Express Pharma 16-31, 2013

VOL .8 NO.20 PAGES 90

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Market Pharmacovigilance: Is India losing the way?

Management Pioglitazone: The saga continues...

Pharma Life Losing ground?

16-31 AUGUST 2013, ` 40

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V O L 8 . N O . 2 0 AU G UST 1 6 - 3 1 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Pioglitazone: The saga continues

BUREAUS

PAGE 33

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

US Supreme Court squares off on human

Bangalore Neelam M Kachhap

RESEARCH

gene patentability

PAGE 38

Regulators pave way for dissimilar drug

Delhi Shalini Gupta

breakthrough

MARKETING

PAGE 39

FDA rejects Merck insomnia drug, seeks

Deputy General Manager Harit Mohanty

lower-dose

Senior Manager Rajesh Bhatkal

PAGE 40

LAB NEXT SPECIAL

PRODUCTION

Viral contamination: Detection and

General Manager B R Tipnis

removal

Manager Bhadresh Valia

Encapsulation and spray drying solutions by

Asst. Manager - Scheduling & Coordination Arvind Mane

BUCHI

Deputy Art Director Surajit Patro

LOSING

Senior Graphic Designer Rushikesh Konka Photo Editor Sandeep Patil

GROUND?

Layout Rakesh Sharma

Circulation Team Mohan Varadkar

August 16-31, 2013

‘We consider external experts’ engagement and clinical research as a major business area to grow’

PAGE 46

Facility design requirements for high potency APIs

C I R C U L AT I O N

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.

PAGE 44

PHARMA TECHNOLOGY REVIEW

Chief Designer Pravin Temble

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.

PAGE 42

PAGE 48

PHARMA LIFE Losing ground?

PAGE 79

United Way of Mumbai and AmeriCares India

MARKET

commemorate World Hepatitis Day

‘R&D focus is increasing in India’

PAGE 81

PAGE 22

SC asks centre to discuss clinical trial regulation with state/ UT health authorities

PAGE 23

State/UTs drug regulators await order to monitor drug price revision process

PAGE 24

Intas finalises corporate plans post IPO

PAGE 25

IMA opposes proposed one year pharmacology course for non MBBS doctors

PAGE 26

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EXPRESS PHARMA

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EDITOR’S NOTE The pio'glitch'azone story

PIOGLITAZONE'S RE-ENTRY INTO THE MARKET COULD WELL BE THE ACID TEST OF THE PVPI AS WELL AS OTHER REGULATORY MECHANISMS OF INDIA'S HEALTH MINISTRY

Now that the Ministry of Health and Family Welfare (MOHFW) has rolled back the ban on pioglitazone, it is time to mull over the key takeaway messages from this episode. Two stories in the August 16-31 issue attempt to do this from two different perspectives.

The story, 'Pioglitazone: The saga continues' mirrors the dilemma of the prescribing community: how do they heal without harming? Every doctor wants only the best for his patient. But, do we have a system in place to find out if today's wonder drug is truly as good as it seems? Unfortunately, the answer is no. Pioglitazone has been available in India since March 2001 but more than a decade later, we still do not have the data to show us conclusively that it has no long term side effects on patients in India. So, do we conclude that the absence of proof is proof enough of its safety?

The second story, 'Pharmacovigilance: Is India losing the way?' is an analysis of India's attempts to put in place a drug safety monitoring system and the many challenges along the way. Experts argue that while the Pharmacovigilance Programme of India (PvPI) looks good on paper, the reality is very different. The biopharma companies who do have a PV structure in place unfortunately look at PV as a cost, required by law, rather than implementing it in the true spirit. PV spends need to be positioned as an extension of a company's commitment to patient care.

In fact, pioglitazone's re-entry into the market could well be the acid test of the PvPI as well as other regulatory mechanisms of India's health ministry. For instance, who will monitor that not only do all packs of pioglitazone and its formulations have a 'red box' warning but also have product inserts and promotional literature with the same warning in bold red letters? Who will check that doctors follow all four conditions laid out in the ‘Advice to healthcare

professionals’ checklist? Who will ensure that doctors are in fact reviewing the response of the patients on the drug at three-six month intervals?

The fact that diabetes has reached epidemic proportions in our country make it all the more urgent to have a robust system in place to search for the proverbial needle in the haystack. Many factors, like genetic variations, cultural and dietary habits, concurrent use of traditional medicine, complicate the equation between medication use and clinical outcomes in India and thus a glitch-free PV system is a safety net we must have.

The silver lining to the whole controversy is that hopefully, patients and their relatives are today more aware that all medicines can potentially have side effects. This awareness needs to be increased and sustained, because at the end of the day, a patient is a consumer and sooner or later, the patient community will have to take care of its interests.

This is already happening in other countries.

Industry observers point out that patients in the US who developed bladder cancer after being on pioglitazone for four years, sued the pharma company alleging that it did not provide adequate warnings to doctors and patients on the drug's link to an increased risk of such cancers. India has a relatively poor history of such product liability claims, and it is likely that again the lack of data will be cited as a reason to discredit such claims. Just as patient groups have had to agitate for more affordable cancer medication or stop improperly conducted clinical trials, unless pressure builds up on the PV front, progress will be sluggish.

Everyone - from patients, doctors, biopharma companies and finally the health authorities – will have to work together to develop a fool proof system to test even the most trusted of medicines. After all, it is better to be safe than sorry.

Viveka Roychowdhury viveka.r@expressindia.com

12 EXPRESS PHARMA

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August 16-31, 2013

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W H AT ’ S INSIDE

‘R&D focus is increasing in India’ PG 22 SC asks centre to discuss clinical trial regulation with state/UT health authorities PG 23 State/UTs drug regulators await order to monitor drug price revision process PG 24 Intas finalises corporate plans post IPO PG 25 IMA opposes proposed one year pharmacology course for non MBBS doctors PG 26 Piramal Enterprises receives IND approval from US FDA PG 27 Increasing product pipelines in acute care environment drive M&A activity PG 28 BIORx launches BIO-Accelerator Programme PG 29 LOC OF 65th Indian Pharmaceutical Congress felicitates Atul Kumar Nasa, President, IPCA PG 32

MANAGEMENT 33 RESEARCH 39 LAB NEXT SPECIAL 41 PHARMA TECHNOLOGY REVIEW 45 PHARMA LIFE 79 August 16-31, 2013

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DR PIPASHA BISWAS

T The thalidomide tragedy of the 1960s is today recognised as one of the most horrific examples of the side effects of medicines. Prescribed to relieve morning sickness in early pregnancy, the world was shocked by its side effects, when babies exposed in utero to thalidomide were born with serious deformities and congenital defects.

Until the thalidomide tragedy, drugs were not monitored for their possible impact on foetuses, even though it was already recognised that alcohol could across the placental barrier and affect foetal development. Thalidomide was subsequently banned and the incident marked a landmark change in the drug monitoring process. Teratogenicity testing and safety laws were framed to monitor medicines for safety and quality.

Today, drug safety monitoring has evolved into a separate branch of pharmacology – pharmacovigilance (PV) – defined as the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines. Regulators and governments rely on such data to evaluate the benefit:risk ratio of a particular molecule when considering it for marketing approvals.

Many drugs have been withdrawn from the market due to safety issues. The biggest drug recalls in recent history are Rofecoxib (Vioxx) which was withdrawn in 2004, natalizumab (Tysabri, 2005), and valdecoxib (Bextra, 2005.)

An analysis of reasons published by the US FDA and previous reports regarding drug recalls and withdrawals list the top nine safety reasons

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Principal Consultant, Director & QPPV of Symogen

DR J VIJAY VENKATRAMAN Managing Director & CEO, Oviya MedSafe

MOIN DON Executive Director & Founder, PVCON Pharmacovigilance Auditing Consulting Services

India's PV system looks like a cut and paste job without taking into consideration the Indian scenario and needs improvement and refinement

A company's compliance is an extrapolation of the country's culture and does not depend on whether the company is an innovator or a generic player

Indian companies are now open to have PV systems in order to enter US and EU markets

for withdrawals as hepatotoxicity (27.9 per cent), cardiovascular toxicity (17.4 per cent), haematologic toxicity (10.4 per cent), cutireaction (7.0 per cent), carcinogenicity (6.3 per cent), neurotoxicity (6.3 per cent), nephrotoxicity (5.6 per cent), allergy (3.5 per cent) and drug abuse (3.5 per cent).1 One of the prime reasons for pharma companies to invest in PV systems is to proactively monitor their products' safety profile, as drug recalls result in substantial loss in revenues as well as reputation of the company concerned. Imran Ali, Senior Director & Global Head, Safety Operations, Global Data & Safety Monitoring, Quintiles lists the long term benefits of PV saying, “The benefits for biopharma companies from PV are primarily the ability to maximise drug safety and secure and maintain public trust and confidence. PV helps in proactively assessing drug risk through its product lifecycle, evaluating drug to drug interactions and designing risk mitigation strategies.”

worth $1.86 billion in 2008 and is estimated to touch $2.25 billion in 2015, says Nidhi Saxena, CEO, Karmic Lifesciences quoting from a Frost & Sullivan report on the World Pharmacovigilance Markets. The PVG market is thus growing at a CAGR of about 15 per cent. “Globally, with new regulations and greater safety awareness, PV is becoming an increasingly important activity for all pharma companies and we are seeing see a rapid growth in this area,” explains Saxena.

Confirming this trend, Moin Don, Executive Director & Founder, PVCON Pharmacovigilance Auditing Consulting Services, observes that Indian companies are now open to have PV systems in order to enter US and EU markets where, without such PV system registration or reregistration, and hence marketing of their products is not possible.

reflected the loopholes in the country's mechanisms to report incidents concerning drug safety and the dire need to build and strengthen a countrywide PV system.

Even though he points out that pioglitazone has not been globally banned or even wholly withdrawn from Europe or North America, Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe, agrees that the longterm solution to such critical issues concerning the safety of patients is establishing a robust PV system that includes all stakeholders of drug safety with the sole aim of ensuring that the benefitrisk ratio is in favour of the patients.” (For more reactions after the revocation of the ban, see story, ‘Pioglitazone: the saga continues’, pages 33-36) As he explains, Indian data for pioglitazone becomes significant because the drug's role in the development of bladder cancer is still a matter of controversy, contrary to the case of rosiglitazone for which there was global evidence in favour of its withdrawal from the market.

India's first steps towards a PV framework was in 1986 when an ADR monitoring system was put in place with 12 regional centers serving a population of 50 million each.

This system was not so successful and India's next attempt was in 1997 when the country joined WHO's ADR monitoring programme based in Uppsala, Sweden. But India's contribution to the global ADR database was too scant, pointing to the lack of

Drivers of change Bioharmaceutical companies have thus had no choice but to invest in a PV strategy.

The escalating costs of getting a molecule to market have seen most pharma companies outsource key components of the R&D and clinical trials process and PV requirements too have gone the same way.

This has led to a growth in the demand for PV services.

The global PV market was www.expresspharmaonline.com

Building a case for PV in India Given that investments in PV are linked to regulatory oversight, it is safe to assume that since India's PV system is still in evolution, companies have not yet taken it too seriously. India's PV framework (or rather the lack of it) was once again in the spotlight recently, with various industry representatives protesting that a ban on pioglitazone was unwarranted as there was no data of pioglitazonerelated adverse drug reactions (ADRs) in India. The ban has since been rolled back but these arguments

August 16-31, 2013

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traction within the industry at that point of time. India's third attempt, in 2004, the National Pharmacovigilance Programme, with WHO funding had to be re-conceptualised.

Renamed the Pharmacovigilance Programme of India (PvPI), it has been operational in this avatar since July 2010. Dr Vijay says that today, the PvPI is the main repository of suspected post-marketing adverse drug reactions in India.

Unfortunately India's PV system has not evolved as fast as it could have. Dr Deven V Parmar, Chief Scientific Officer, Karmic Lifesciences points to data released by the Uppsala Monitoring Centre, where India does not feature in the list of active Individual Case Safety Reports (ICSRs) in the WHO global ICSR database from March 2008-2013.

(See chart: List of active ICSRs in the WHO global ICSR database from March 2008-2013) Explaining the basis of PV systems, he quotes from Cicero in ancient Rome who

August 16-31, 2013

said, "Salus populi suprema lex esto," meaning that 'the welfare of the people is to be the highest law.' But he alleges that only a handful of Indian companies have a basic PV programme in place.

“By and large, not many Indian companies feel a PV system or department is a necessity. Only Indian companies who have products being sold in emerging and established markets where the regulation mandates them to submit Periodic Safety Update Reports (PSURs) would have a rudimentary system in place,” he says.

Even with these systems Parmar questions the accuracy of the data since for instance, the collection of the data for a PSUR would be through medical representatives, who are more focused on reaching their targets, as compared to collection of data.

This lack of commitment to a PV strategy is critical when one considers the various complications that could arise. Ali of Quintiles stresses

www.expresspharmaonline.com

this aspect of PV data saying, “It is very critical for India to have her own PV monitoring system on account of our ethnic variability, demographic profile, cultural differences, indigenous systems of medicine, etc which can all impact the safety and efficiency profile of the drug with the Indian population.” His reading is that given the Indian regulatory authorities’ increased focus on PV, biopharma companies are increasing their efforts to align with stringent Indian and global safety PV norms.

A will but no clear way?

Dr Vijay observes that in general, biopharma companies want to be compliant with regulations. A prime reason is that with globalisation, “compliance with one country's regulation helps a biopharma company get into the good books of another, which is vital for their business expansion.”

He sees no difference in the attitudes between innovator and generic companies

abroad as both treat compliance issues with equal importance. However, in India, the enforcement of the laws governing compliance issues is “ambiguous” and only the companies that are keen to remain compliant with Indian regulations choose to be compliant. Thus he feels that a company's compliance is an extrapolation of the country's culture and does not depend on whether the company is an innovator or a generic player.

If the recent outcry protesting the ban on pioglitazone and other drugs like the popular painkiller Analgin were any indication of India’s PV culture, the country still has a long way to go. Experts with experience of global PV systems like Dr Pipasha Biswas, Principal Consultant, Director & QPPV of Symogen, argue that India's PV system “looks like a cut and paste job without taking into consideration the Indian scenario and needs improvement and refinement.

Comparing other emerging and developing countries

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like China and in the ASEAN region like Thailand, Singapore etc Biswas comments that India is lagging behind in terms of regulations, implementation, funding, human resources, the desire to make it happen and several other reasons.

For instance, she points out that China's PV reporting has increased significantly since 2005. The Chinese government has built a robust infrastructure and is working in sync with healthcare professionals, hospitals and various provincial agencies to take it to the next level. The Chinese government has also increased the monetary funding and is serious about PV activities.

According to Biswas, this is the case with other ASEAN countries as well, who have a far more reporting rate of adverse events to their respective regulatory agencies than India.

These regulators obviously see the benefits of these investments because as

Biswas reasons, increased (PV) reporting from within the country helps the regulatory agencies in that country to make effective decisions about the product when there are issues with the products.

Secondly, the poor quality of human manpower is a difficult situation in India that does not help either.

Peer to peer comparisons But India is not the only country with teething trouble on the PV front. Parmar quotes from a paper comparing PV systems in 55 low and middle income countries which shows that 45 percent of the PV centres (114) in the analysis were established during the 1990s and 49 per cent were set up later; 69 per cent were affiliated with their Drug Regulatory Agency, 20 per cent with the Ministry of Health and 9 per cent with a university or other scientific body. Less than half of the countries (23 of 55) have any budget allocated for PV. Public health programmes (44

List of active ICSRs in the WHO global ICSR database from March 2008-2013

per cent), the Global Fund to fight AIDS, Tuberculosis and Malaria (36 per cent), universities (26 per cent), poison centres (21 per cent), Management Sciences for Health (18 per cent) and Rational Use of Drugs networks (15 per cent) sponsor some PV activities.2 Having worked across geographies, Ali lists the several issues and challenges faced by developing countries as compared to the developed world pointing out that there is no data on ADRs that may occur due to the interaction between established medicines and traditional, herbal medicines and vaccines used locally. ADRs reporting for traditional and herbal medicines, especially the multicomponent and adulterated ones, is not addressed seriously enough.

Also, in a predominantly generic market, there is no accountability of PV when innovator products are taken off the market. Many admit to not investing in ADR monitoring considering that they deal with off-patent products, observes Ali. Further analysing the performance gaps in India's PV system, Dr Vijay says that though the PvPI is a huge step forward in the right direction for collating Indian drug safety data, it is currently restricted to the approved medical college hospitals in India, public health programmes, and autonomous institutes like the Indian Council of Medical Research (ICMR).

Moreover, he points out that the data received by the PvPI by way of ICSRs is shared only with the World Health Organization (WHO) but not with the concerned pharma companies thereby denying them of the opportunity to become aware of adverse events associated with the drugs they market and take corrective actions.

Apart from PvPI, some Indian pharma companies too receive adverse events, process them and report them to the CDSCO. The CDSCO headed by the Drug Controller General of India (DCGI) mandates the submission of PSURs for new drugs but not all biopharma companies are compliant, says Dr Vijay.

Creating a PV culture Ali too feels that the objective, planning and focus of PvPI “hold great promise” as it has considered the challenges faced in the previous

Source: http://who-umc.org

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programmes and the collaboration with medical institutions and corporate hospitals and is slowly creating an ADR reporting culture and practice.

But he points to the challenges in reporting ADRs like lack of awareness of reporting systems and not knowing what exactly to report.

“Reporting of ADRs is considered low priority. The fear of impact on reputation and medico legal issues is also a deterrent. This is compounded by the existence of numerous brands from various companies, multiple unapproved combination drugs and concomitant use of Indian system of medicine that complicate the entire reporting process,” says Ali elaborating on the many interconnected issues.

Giving the doctor/clinician perspective, Dr Vijay says, “The overall awareness of PV or rather the lack of it is the first challenge. The perception that any approved drug is unconditionally safe is widespread not only among the patient population but also among the medical fraternity. Doctors and other healthcare professionals should be motivated to report any untoward occurrence that happens after the administration of a drug, without wondering if it would be biopharmacologically possible, in order to identify hitherto unknown adverse drug reactions.”

However, he is optimistic that the Indian regulators have begun to show positive signals to energise Indian PV. He sees this as a “transition phase” as the Indian biopharma industry adapts to global drug safety standards in line with the country emerging as an 'innovator market' and shedding its image of being just another huge 'generic market'.

Regulatory gaps Parmar of Karmic Lifesciences sums up the current scenario when he says, “Today PvPI is strong on paper, however the question is, how many centers are actually collecting the data and submitting the same?”

Don points out that the Indian PV regulations are not in synchronisation with ICH or international guidelines.

The latest update on safety reporting requirement from clinical trials would result in many fold reporting of SAEs, both relevant as well as irrelevant to the trials, to DCGI’s office. He feels that the curAugust 16-31, 2013

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rent PV programme is doing much better but there are still centres around India where reporting numbers are abysmally low or nought and therefore we need to create awareness, and educate the stake holders in appropriate manner.

India's sheer geographical mass also adds another dimension to the regulator's task, because as Biswas of Symogen points out, the PvPI programme currently lacks the infrastructure needed for such a vast country. Thus the overall sense is that there would be more openness to the idea of implementing PV systems if the regulations were better framed.

Involving all stakeholders There is consensus that if the PvPI needs to succeed, there needs to be greater involvement at the grass roots level. Ali points out that there is a need to increase awareness of healthcare professionals and the public in the understanding and importance of PV. This should

include proactively demonstrating the benefits of collecting ADRs to medical professionals and creating awareness amongst the general public through product inserts/labeling sheets on PvPI and where to report ADRs as also introduction of a toll free number for reporting ADRs. Besides doctors/clinicians who have an important part in identifying and reporting ADRs, Ali says that the accountability of biopharmacists and paramedics in reporting ADRs should also be enhanced.

At another level, Ali says that academic curricula should be enhanced to include PV for all healthcare and paramedical courses and the practice of reporting ADRs should be inculcated during internship and postgraduate programmes which will ensure strong foundational training.

At the regulator level, he opines that the PvPI workforce needs to be strengthened to handle incoming

ADRs and ensure the processing of these events on time and there needs to be ongoing collaboration with various stakeholders for enhancing the programme.

Finally, Ali stresses that there is a strong need to create fora where regulators and the biopharma Industry interact with clinicians, patient groups and the general public to create awareness of the ADR reporting system and the immense benefit it has in patient safety. The PvPI’s involvement in these stakeholder partnerships would help create great and sustained value in the near future, according to Ali. Industry associations should also be harnessed to drive this change. Parmar suggests that national bodies like the Indian Medical Association, Association of Medical Consultants, and others such as Association of Physicians of India, etc. can be roped in to strengthen the links between the various parts of the ADR system. Most consultants are not aware of

PV practices in India and in fact, Parmar opines that the Medical Council Of India should make it a compulsory learning for all doctors in order to renew their licenses.

In a similar vein, he recommends that the authorities should seek the cooperation from their counterparts in Unani, Ayurveda, Pharmacy & Allied branches of medicine as well.

The way forward As the biopharma sector is a heavily regulated sector, it follows that rules and laws are a major driver of change.

Thus regulators are no doubt aware that the guidelines and laws they frame today will dictate the destinies of the sector going forward.

Therefore industry stakeholders are unanimous that the DCGI/CDSCO are on the right path but have many suggestions to improve /refine the framework.

Dr Vijay reasons that though PvPI is emerging as one of the largest and reasonably structured PV pro-

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grammes in Asia, India does not have specific guidelines for PV as are available in the EU and the US. Schedule Y primarily focuses on clinical trial safety but not much mention is made in it about postmarketing PV, unlike emerging and developing countries similar to India such as Brazil and Saudi Arabia, which have formed their own PV guidelines by customising the guidelines of the matured markets.

Taking this thought further, Dr Vijay says, “With globalisation being the rule today, we would always benefit with our regulators getting to discuss more and more with their counterparts across the globe, as it would result in earlier awareness in India about any global drug safety issue and increased possibility of prior adoption of global drug safety strategies by India also.”

He also suggests that our drug regulators could call for proactive Risk Management Plans from biopharma companies that market drugs which have been implicated in safety issues to understand and evaluate the risk minimisation procedures put in place by them, as is the case in many other countries, instead of abruptly suspending a drug just on the basis of suspicion.

This would provide a fair chance to quantify how safe or unsafe a drug is before deciding for it to be banned and this decision would be particularly important in the case of life-saving drugs since recalling them from the market would anyway impact the patients directly, he reasons, obviously referring to the aftermath of the pioglitazone episode.

PV solutions: options galore Biopharma companies looking at setting up PV systems have the option of doing it themselves or outsourcing the entire process or parts of it to a growing list of PV specialists. Services and solution providers can be broadly categorised into CROs which offer end to end services, BPOs who have offer selected services like case processing activities for safety services along with additional safety knowledge and reporting services.

Ali also points out to a more recent trend of small scale consulting groups who have started to offer a wide range of safety services. In

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IMRAN ALI

NIDHI SAXENA

DR DEVEN V PARMAR

Senior Director & Global Head, Safety Operations, Global Data & Safety Monitoring, Quintiles

CEO, Karmic Lifesciences

Chief Scientific Officer, CSO, Karmic Lifesciences

It is very critical for India to have her own PV monitoring system

Globally, with new regulations and greater safety awareness, PV is becoming an increasingly important activity for all pharma companies

Today PvPI is strong on paper, however the question is, how many centers are actually collecting the data and submitting the same?

addition, some large biobiopharma companies have captive PV units to deliver safety services.

Enumerating the hallmarks of a good PV solution, Ali of Quintiles says the solution must take into account all the core services of safety from case intake, case processing, medical review to regulatory reporting, aggregate reporting, benefit risk evaluation and mitigated safety risks. A good PV solution should be able to provide accepted PV systems (example Argus, ARISg, etc) and standardised operating procedures to avoid the need for companies to invest in their own systems and procedures.

This ability should be available at a global, scalable model and be able to meet the requirements of an ever changing and stringent regulatory environment. All this should be available at reasonable costs and within acceptable compliance and quality standards, he concludes.

Besides these, Saxena believes that companies working to exceed client expectations should have a robust voice of customer process where clients can provide their feedback.

Quintiles' global reach can be gauged by its 1000+ safety professionals across the globe, with dedicated staff in the US, Ireland, Switzerland, India, Singapore, China and Japan.

The company has been providing PV services for 150+ biopharma companies for over two decades and has

processed over 1.5 million adverse events globally as per industry leading quality and compliance metrics.

According to Ali, the company has been audited by several global regulatory agencies with no critical findings. The level of services ranges from advanced specialist support as also PV consulting services for new entrants or small players wanting to establish a PV service as well as outcomes research abilities by harnessing public health.

Homegrown CROs too are as active in the PV space.

According to Saxena, Karmic Lifesciences' current PV team, with 180+ person years’ experience, offers a PV portfolio encompassing endto-end PV and safety services to support US FDA, EMA and local reporting requirements, combined with full service CRO offerings to offer a complete solution to sponsors.

The Mumbai-based company, processes approximately 5000 cases in a year, comprising serious, non-serious and clinical trial cases as well as literature search.

Karmic Lifesciences' PV system was designed and put in place by Don's firm, who says he has worked with a variety of clients ranging from Indian and global MNCs. His client roster includes giant generic biopharma companies, CROs and some KPOs with whom he has been associated with, as a strategic advisor and consultant.

Besides these assignments, Don has been conducting PV audits round the year in the

Asia-Pacific and CIS region as his preferred geography.

www.expresspharmaonline.com

A global approach “The growth prospects for PV solution providers is immense for the next three years or so,” says Don. He sees more business coming to Indian KPOs and PV solution providers like himself, with cost effectiveness as the biggest driver. Thus, services such as end to end case processing of cases, authoring of reports etc has grown many fold in the previous few years due to cost effectiveness of outsourcing vis-a-vis in house processing of cases by foreign MNCs. The expenditure on PV operations per company would largely depend on multiple factors such as nature of operations, magnitude, product portfolio, etc, he explains.

Though PV auditing services from India is a rarity, Don acknowledges that his clientele beyond the country is a testimony to his ability to leverage his personal global networking and brand name / goodwill to tap this potential.

Clearly, India does not lack the PV know-how; what's lacking is the ADR reporting culture and regulatory push.

Another breed of solution providers are cliniciansturned-PV specialists like Dr Vijay, a diabetologist who set up Coimbatore-based Oviya MedSafe along with other clinicians in February this year, to provide PV services.

Initially operating in the European and the North American markets, the company won their first contract August 16-31, 2013

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in the the Middle East market in June, and will to work on Corrective And Preventive Action plans (CAPAs) for one of the largest drug distributors in the region. The company also bagged its first India client in the same month, reportedly one of India's largest biopharma companies, to write their PSURs for submission to the DCGI.

PV solution providers.

The final argument in favour of a robust PV system is that drugs which were previously banned for safety reasons, are being approved, albeit with very strict controls, for certain conditions.

For instance, thalidomide is currently approved under the US FDA orphan drug rules to treat leprosy, even as it

remains a subject of ongoing research to treat other cancers and autoimmune conditions . Its use is minutely supervised to prevent the tragic birth defects associated with its first outing in the 1950-60ties.

Thus the business case for PV is very clear, both for the biopharma clients as well as PV solution providers. But

going by the recent history of regulations for clinical trials, India needs nothing short of a patient uprising, led by pharmacovigilantes, to push the PV agenda forward. Any takers? viveka.r@expressindia.com

References: 1.Man F, Thornton A, Mybeck K et al; Evaluation of the character-

istics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets-1960 to 1999. Source: Drug Inf. J. 35, 293–317 (2001).

2.Sten Olsson, Shanthi N. Pal, Andy Stergachis and Mary Couper; Pharmacovigilance Activities in 55 Low- and MiddleIncome Countries. A Questionnaire-Based Analysis.

Drug Saf 2010; 33 (8): 689-703

A problem of plenty?

In fact, far from a dearth, biopharma companies in India may be faced with a problem of plenty when it comes to choosing PV solution providers. Gauging the merits of each may prove difficult.

Biswas of Symogen cautions that the sector has a the high attrition rate and points out that the “poor quality of work is always in the news.”

She stresses that as PV is a highly regulated area with increased audits and inspections, there are bound to be repercussions sooner rather than later if the quality (of PV work) suffers. “Unless there is improvement by providing Western standard training and increasing knowledge, it will be difficult to continue doing PV (in India),” she says.

To meet this issue head on, one of Symogen's main principles since its inception in 2007 is to train and make their staff knowledgeable in all the spheres of PV especially with worldwide PV regulations so that seamless quality of work can be delivered to clients. The firm has its main offices in the US and Europe, and advocates proactive PV to meet regulatory demands.

Symogen's client list comprises large, mid-size and small biopharma and biotech companies as well as international CROs and BPOs, the likes of Roche Pharmaceuticals, Valeant, Shire Pharmaceuticals, Takeda, Genzyme, and Solvay.

The evolving regulations in the country maybe be a deterrent but pharma companies with global ambitions have no choice but to put a PV strategy in place. So a change in attitude is a given, driven by business realities rather than altruism. And the fact that Ma Foi Strategic Consultants picked up a 17.5 per cent stake in Oviya Medsafe less than a year after its inception is a clear indication of the value addition and long term growth prospects of August 16-31, 2013

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‘R&D focus is increasing in India’ Indian pharma companies seem to be thriving even as large MNCs see a decline in their revenues, reveals GlobalData’s PharmaLeaders: Top 10 Pharmaceutical Companies in India Benchmark Report. Shalini Gupta finds out more in an interview with Adefemi Adenuga, GlobalData’s Healthcare Analyst covering industry dynamics Sun Pharma has emerged the winner. Why and on what parameters?

Sun Pharmaceuticals has emerged as the leader based on impressive performances in financial and capital management in 2012.

Which companies have emerged as revenue leaders and revenue growth leaders? Are they the same? If not why?

The revenue leaders were Ranbaxy, Dr Reddy’s and Sun Pharma; while Sun Pharma, Lupin, and Glenmark emerged as revenue growth leaders in 2012. Larger companies like Ranbaxy and Dr Reddy’s possess a broad range of products, having been in the business for a relatively longer time than Lupin and other players. Therefore, it was not surprising to see them emerge as revenue leaders.

However, relatively smaller companies such as Glenmark and Lupin are more nimble and aggressively growing as they aim to overtake these larger players. For instance, Lupin and Glenmark witnessed sales increases of 41.7 per cent and 46.5 per cent in the US in 2012.

Which companies rank high on operating margin and which rank low? What does this mean?

Sun Pharma, Wockhardt and Cipla were the operating margin leaders, while Aurobindo, Ranbaxy and Torrent were the laggards.

Companies that ranked higher were able to minimise their operating expenses (cost of goods

COMPETITION IS EXPECTED TO INTENSIFY DOMESTICALLY AS COMPANIES WILL SEEK TO INCREASE VOLUME TO BOOST PROFIT. IN ADDITION,THERE WILL BE AN INCREASED FOCUS ON INTERNATIONAL EXPANSION BY DOMESTIC PLAYERS AND MORE ATTENTION TO NICHE DISEASE AREAS,WHERE THEY CAN POTENTIALLY GENERATE INCREASED MARGINS 22

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sold etc.) and so recorded greater margins from their operations.

Are there any observations to note when one observes the companies leading and lagging while comparing operating income and operating income year-toyear growth?

Sun Pharma, Wockhardt, and Cipla emerged as leaders in both operating income and operating income yearto-year growth. Dr Reddy’s was the operating income year-to year growth laggard.

The company’s operating income declined by 0.4 per cent in 2012. Therefore, the company needs to be more cost-efficient.

How do you see the current pricing policy affecting the competitiveness of Indian players, given that their profit margins are bound to come down?

Competition is expected to intensify domestically as companies will seek to increase volume to boost profit. In addition, there will be an increased focus on international expansion by domestic players and more attention to niche disease areas, where they can potentially generate increased margins.

MNCs have lambasted India’s patent laws.

However, what does this mean for domestic pharma, does it stand to benefit or lose? Also, how is the move from being a semi-regulated market to a regulated market going to bode for the Indian pharma?

Undoubtedly, domestic pharma companies, which are primarily generic manufacturers, have and are benefitting from the current state of patent protection in the country. They are able to challenge patents and also obtain compulsory licenses from the government to manufacture generic versions of drugs to treat diseases classified as national emergencies. However, I expect IP protection in India to steadily get stronger over www.expresspharmaonline.com

INTERVIEW

the next few years as the country would need to protect domestic companies involved in developing novel drugs.

Is the investment in new drug development and R&D on the rise? Explain with examples.

R&D focus is increasing in India. In 2012, Ranbaxy successfully launched the country’s first new molecular entity (NME) – Synriam, an anti-malarial drug.

Other companies such as Dr Reddy’s, Lupin, and Wockhardt have also increased their R&D investments recently. Dr Reddy’s R&D investment increased by 25.2 per cent from $103 million in 2011 to $129 million, while Lupin’s grew by 21.7 per cent to $118 million in 2012 from $97 million in 2011. Furthermore, Lupin’s Novel Drug Discovery and Development (NDDD) is currently focused on various therapeutic areas, including oncology, pain management, and infectious diseases.

Though India has the largest number of US FDA approved sites outside the US, how does the Ranbaxy incident cast a light on the industry’s competitiveness?

The Ranbaxy incident casts a negative light on Indian pharma, being one of the country’s largest pharma companies. However, this does not seem to be a general trend in the country

(despite isolated quality issues here and there). The FDA will possibly pay more attention to drugs being manufactured in India – more frequent inspections, etc. (which is one of the aims of the Generic Drug User Fee Amendments (GDUFA) fees).

How are companies coping up with GDUFA? How has it affected them?

It is still too early to gauge how it has affected companies. However, their margins are expected to be reduced. Larger companies should be able to absorb the added costs but smaller ones may struggle unless they can increase volume to compensate for the increase in expenditures.

Finally, given all the challenges and opportunities in view, how are Indian firms restructuring their business models? What constitutes a winning strategy to stay competitive today and in the future?

Indian drug makers are currently increasing their focus on disease areas and segments (including pain/inflammation and autoimmune diseases).

Based on the relatively weak barriers to entering the generics business, price competition has inevitably been decreasing margins.

Therefore, companies are hoping to face softer competition in these niche markets and consequently, enjoy greater margins. We are also beginning to see more interest in the development of novel drugs among domestic companies.

Going forward, Indian companies need to tap into the international market, particularly other emerging markets in Latin America and Eastern Europe, to take advantage of the rapidly increasing insurance coverage and economic growth in these regions. Some of the companies such as Lupin and Ranbaxy are already doing this through subsidiaries in these markets. shalini.g@expressindia.com August 16-31, 2013

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COMPANY WATCH SC asks centre to discuss clinical trial regulation with state/UT health authorities PIL petitioners to submit suggestions in two weeks; ISCR expresses concerns on slowdown of trial approvals

which has the greatest impact on patients for many of whom clinical trial provides early access to a new treatment and for others, the

last option or hope of a cure.

Without clinical trials there can be no new therapies, said the ISCR statement. The SC has also asked the Secretary,

Ministry of Health to file an affidavit in compliance of this order within six weeks from July 26, with copies sent to the counsel for the petition-

ers, counsel for the states governments/Union Territories, Commission and proposed intervenors.

EP News Bureau-Mumbai

ndia's Supreme Court, in its July 26 order, has directed the Secretary, Ministry of Health to convene a meeting of the Chief Secretaries/Health Secretaries of the State Governments and the Administrators of the Union Territories to discuss all the facets and aspects concerning the legal framework for strengthening the regulation of clinical trials and other incidental matters. The centre has been given four weeks to conduct this meeting.

The SC order followed the hearing of a PIL filed by various NGOs criticising the conduct of clinical trials in the country. Even as the SC acknowledged the steps taken by the Ministry of Health to strengthen regulation of clinical trials in India, the petitioners submitted that the proposed measures do not answer many issues, particularly with regard to clinical trials of new chemical entities as well as the controlling and monitoring measures.

The SC has also granted two weeks time to the petitioners, National Human Rights Commission, NGOs and other proposed intervenors to submit their suggestions concerning the regulation and monitoring of clinical trials to the Secretary, Ministry of Health.

The SC order takes cognisance of Madhya Pradesh's counsel submission that they had not been consulted on the measures needed to strengthen regulation of clinical trials, which was necessary as the state governments are directly concerned with the matter. The MP counsel indicated that this is the stand of almost all the States/Union Territories.

While an ISCR statement said that it was ‘fully supportive’ of these initiatives it also expressed its concern with regard to the slowdown in granting approvals for clinical trials in the country

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August 16-31, 2013

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State/UTs drug regulators await order to monitor drug price revision process Karnataka state regulators write to state govt; Maharashtra and Gujarat gears up for action Usha Sharma – Mumbai uly 29 was the D-day when the first batch of medicines with revised prices as per the Drug Price Control Order 2013 (DPCO) were to be on chemist shelves. But as industry associations and individual companies file cases and make representations to stall/postpone implementation of the new pricing regime, state and union territory regulators reportedly have not yet received any official communication from the National Pharmaceutical Pricing Authority (NPPA) empowering them to monitor the price revision process.

The Department of Pharmaceuticals (DoP), in order to make affordable medicines available in India, had released an order on May 15 and provided a 45day period to pharma companies to implement the revised prices on medicines falling under the Drug Price Control Order 2013 (DPCO).

J

In the first batch on June 10, National Pharmaceutical Pricing Authority (NPPA) has revised 86 formulation packs but more than a month later there is no official communication to Indian State/Union Territories’ offices authorising them to monitor the implementation of the price revision process.

As per a DoP order dated May 15, any gazetted officer of the Central Government or of a State Government, in order to check compliance with this order could enter and search any place as well as seize any drug, along with the containers, packages or coverings.

However as per another DoP order dated May 30, the Central Government has directed that only the NPPA would exercise the functions of the Central Government on this issue and in turn empower the state regulators to take action if required.

Commenting on the two orders, Dr Bharatesh Jagashetty, Drug Controller, Karnataka said, “So far we have not received any official direction either from the

Government of India or NPPA. However, we have approached the Karnataka Government and asked them to give our drug controller officers the power to authorise such actions in order to monitor the implementation process as per paragraph 30. We hope to receive a formal notification from the state government in a couple of days.”

When contacted by Express Pharma, and asked to clarify who was the designated authority to implement the process, Pradeep Yadav, Joint Secretary, DoP replied, “DoP has mentioned that NPPA is the authorised body to govern the order through the State and Union Territories (UTs). If NPPA has not communicated officially with the state/UTs drug regulators, then we will direct them and very soon all the states and UTs will get a notification from NPPA.” Omprakash Sadhwani, Joint Commissioner, Food and Drugs Administration commented, “Though we have not heard anything officially from NPPA, we have still started working on the

revised prices at Maharashtra FDA office. In a day or two, our drug inspectors will make surprise visits to different chemist shops located in Maharashtra and check whether pharma companies have implemented the revised prices or not.

However, we are also awaiting an official communication from NPPA.” Dr Hemant Koshia, Commissioner, Food and Drugs Control Administration (FDCA), Gujarat highlights, “As per DPCO 2013, we have already started collecting primary data related to price variation of the revised drug prices and our drug inspectors are working on it.”

He also mentioned, “It is a known fact that the Government of India enforces the orders and state authorities are liable to implement in their respective states. However, we hope that some official communication will be released by the NPPA and we will be officially authorised to work on this direction. We hope to hear from NPPA in the next two to three days.” u.sharma@expressindia.com

Claris Lifesciences completes transfer of infusion biz in India and emerging markets to Otsuka JV Receives a total cash consideration of ` 1050 crores as a part of the transaction from Claris-Otsuka laris Lifesciences, India (Claris) has completed the transfer of its infusion business for India and emerging markets to the joint venture (Claris-Otsuka) with Otsuka Pharmaceutical Factory, Japan (OPF) and Mitsui & Co, Japan (Mitsui).

The infusion business includes common solutions, anti-infective, plasma volume expanders and parenteral nutrition therapies for India and emerging markets. Claris has transferred two of its existing plants to the joint venture. Claris will continue to hold a 20 per

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cent stake in the joint venture while Otsuka and Mitsui will hold 60 per cent and 20 per cent respectively.

Claris has received a total cash consideration of ` 1050 crores as a part of the transaction from Claris-Otsuka.

Claris-Otsuka is valued at ` 1313 crores.

Claris has used a part of the cash consideration towards debt prepayment of around ` 360 crores, and sub-

ject to regulatory approvals it intends to reward shareholders via buyback of shares for which it has allocated ` 300 crores. The remaining funds net of taxes and deal related expenses will be used to fund future growth of the company.

Claris Lifesciences has 11 ANDAs approved in its name across seven molecules with a total filing of 31 ANDAs across 22 molecules

CLARIS WILL CONTINUE TO HOLD A 20 PER CENT STAKE IN THE JV WHILE OTSUKA AND MITSUI WILL HOLD 60 PER CENT AND 20 PER CENT RESPECTIVELY www.expresspharmaonline.com

and a pipeline of 20 ANDA to be filed.

According to a release, Claris will remain focused on its speciality generic injectables business and shall intensify its growth in all international markets, especially the regulated markets (including the US) through new product launches. The company will continue to increase its focus on bag products and other niche ‘difficult to manufacture’ products as well as work on fast track growth opportunities via organic (capacity expansion and introduction of new delivery systems) and inorganic (acquire products and ANDAs) routes.

EP News Bureau-Mumbai August 16-31, 2013

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Intas finalises corporate plans post IPO Focuses on European market and setting up of a new R&D centre in Ahmedabad Usha Sharma – Mumbai hmedabad-based Intas Pharmaceuticals has chalked out its expansion plans post the upcoming initial public offering (IPO) worth ` 225 crores. The company will mainly focus on strengthening its presence in the European market and invest ` 122 crores for obtaining marketing authorisations.

Recently, Intas Pharmaceuticals has filed a draft red herring prospectus (DRHP) with SEBI for the IPO. Jayesh Shah, Chief Financial Officer, Intas Pharmaceuticals shared the company's corporate plans and provided the break up of the IPO amount and commented, “From the IPO, we shall be able to raise ` 225 crores, and plan to invest ` 122 crores in obtaining marketing authorisations in Europe, ` 68 crores for setting up a new research and development (R&D) facility in Ahmedabad and the balance amount of `35 crores will be spend for corporate purposes and other expenses.” The company has 40 new molecules at different stages of completion. These molecules are targeted for registration in various countries in Europe.

It has molecule for oncology (11), cardiac (10), pain management (3), CNS (3), gastro intestinal (3), anaesthesia (2), anti infective (2), dermatology (2), anti parasite (1), gynaecology (1), and two molecules for other therapeutic areas.

Commenting on strengthening the company’s presence in the European market, Shah said, “For the European market, we have 40 molecules for different therapeutic areas registered in various countries. In 2014-15, we will invest ` 81.5 crores and in 2015-16 we plan to invest ` 40.5 crores.”

As mentioned, Intas Pharma will invest ` 68 crores for setting up the new R&D centre. The company will invest ` 47 crores for the plant and machinery, ` 17 crores for civil work and ` 4 crores for other works in order to set up the R&D centre. While speaking about the new R&D centre, Shah said, “Considering the consistent

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August 16-31, 2013

growth of more than 25 per cent compounded annual growth rate (CAGR) since the last six years, we felt the need

to establish a dedicated R&D centre to maintaining the future pace of growth. The new R&D centre will be established at the existing site of manufacturing facility.”

Recently, Intas Pharma and its wholly-owned

subsidiary Accord Healthcare entered into a settlement and license agreement with Hoffmann-La Roche Inc. Commenting on the recent settlement, Shah highlighted, “The recent settlement and licensing agreement with

Roche will enable the company to launch the product ahead of its exclusivity period which presents an upside for the company which is market size of the product being in excess of $ 0.7 billion.” u.sharma@expressindia.com

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IMA opposes proposed one year pharmacology course for non MBBS doctors Alleges that the real problem is infrastructure not availability of doctors Usha Sharma – Mumbai he Indian Medical Association (IMA) is opposing the Health Minister of Maharashtra’s proposal of a one-year pharmacology course for non-MBBS doctors to allow them to conduct medical practices in the State. The Health Minister has proposed a modern medicine certification course for non MBBS doctors in the ongoing monsoon session at the Maharashtra State Assembly.

Reacting to the announcement, IMA wrote a letter on July 19, to the Union Health Minister, State of Maharashtra Raj Bhavan, State of Maharashtra Mantralaya, Health Minister Mantralaya, Ministry of Health Education Mantralaya and Ministry of Cultural Affairs Mantralaya explaining the seriousness of the issue with its far reaching consequences and doctors' concerns.

The letter from the IMA does not only pertain to the practice of allopathic doctors but is from a larger conceptual viewpoint viz. that the life of the common man is being endangered and empowering doctors who are practicing in Ayurvedic, Unani and

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Homeopathic medicines to prescribe medicines without undertaking an appropriate course of anatomy, physiology, pathology, microbiology and other related subjects for a perfect diagnosis of the disease is very dangerous to the life of the common man.

The IMA letter also highlights that introducing such a course is not only 'illegal, unlawful and highly unconstitutional' but also cannot stand scrutiny in a Court of Law. It further points out that the law and Maharashtra University of Health Sciences (MUHS) does not recognise the ‘concept of a certification course’ as a course can be only a degree or a diploma as per Schedule 7 of the Constitution of India, they are legislations enacted by the Central Government in the nature of Indian Medical Council Act, 1956.

The IMA letter cautions that if the proposed ordinance and/or legislation is approved by the legislative assembly and legislative council, it would be in conflict with the provisions of the Medical Council Act and in the absence of any assent by the President of India under Article 254 of the Constitution of India, it would be unconstitutional and illegal.

As one of the signatories of the letter, Dr Jayesh Lele,

State Secretary, IMA said, “There are many judgments from the Supreme Court as well as from various States against the cross-pathy medical practices.”

On the other side of this debate is Dr K Tripathi, President, National Integrated Medical Association who rationalised the Maharashtra Health Minister's proposal saying, “We feel that after inclusion of a proposed one year course the legal competency issue can be easily solved. This will allow graduates of the Indian System of Medicine (ISM) to be legally competent and the government can also access these graduates for rural areas where we have a scarcity of qualified doctors.”

The IMA has alleged in its letter that there is no shortage of doctors in rural Maharashtra, saying that the IMA has about 191 branches in the state and even in the remotest rural area like Gadchiroli, doctors are available. Lele strongly feels that it is not correct to allow 'under taught doctors' to prescribe modern allopathic medicines under the pretext that there are less doctors in rural areas. 'This is a kind of back door entry into the allopathic practice,' states the IMA letter.

The IMA letter goes on to

state that many rural areas do not have any hospitals and when hospitals are available at the district level, there is no sufficient infrastructure to run them. It strongly highlights that what is lacking is not the availability of doctors in rural areas but availability of infrastructure for the healthcare of poor people to be established.

It is seen that most rural areas do not even have primary health centers established by the Government.

Tripathi however emphasises that the proposed course will be beneficial for the National Rural Health Mission (NRHM) scheme as it will increase the number of competent doctors in society and provide better access to healthcare.

“The core agenda behind opposing the proposed course is to create a monopoly on the medical services, making healthcare services more costly and out of reach of the common people. This shows that the IMA is showing their professional jealousy towards us,” feels Tripathi. IMA expects the Government to refrain from introducing any such act or ordinance and suggests that the Government should instead focus on taking steps to strengthen the infrastructure in the rural health programme.

critical to determining the effectiveness of IDRI’s VL vaccine candidate and ensuring it is approved and available within endemic countries.

IDRI’s VL vaccine candidate, LEISH-F3+GLA-SE, is the product of more than 20 years of research and development supported by the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation.

The defined, purified, recombinant vaccine comprises two fused Leishmania parasite proteins and an adjuvant to stimulate a protective immune response against the parasite. After completion of a Phase 1 clinical trial of 36

US adult volunteers to test safety and immunogenicity, the vaccine was shown to be safe and to induce potent immune responses in healthy volunteers.

Speaking on the development, Pankaj R Patel, Chairman and Managing Director, Zydus group said, “Zydus has always been committed to working with partners and collaborating to bridge unmet healthcare needs. By partnering with IDRI on this important mission, we will be taking an all important step to eradicate visceral leishmaniasis which is a huge healthcare burden.”

EP News Bureau-Mumbai

u.sharma@expressindia.com

Zydus and IDRI sign agreement Zydus & IDRI will collaborate to conduct clinical development activities in India for visceral leishmaniasis (Kala-Azar) ydus, an innovation-led global healthcare provider and IDRI, a Seattle-based non-profit research and product development organisation are collaborating on the production and clinical development of IDRI’s visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease.

Known as Kala-Azar in India, VL is transmitted by the bite of an infected sand fly. There are over 500,000 new VL cases and 50,000 associated deaths each year.

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VL is the most severe form of leishmaniasis, affecting vital organs, and, if left untreated, the disease can be fatal. A vaccine is considered essential to control and eliminate the disease.

Zydus and IDRI will collaborate to conduct clinical development activities in India with the goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access – that is, ensuring the vaccine is affordable and accessible to all people in need.

Conducting trials in India, where there are real-life situations of disease exposure, is www.expresspharmaonline.com

August 16-31, 2013

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Piramal Enterprises receives IND approval from US FDA P7435 is a novel DGAT1 inhibitor for treatment of lipid disorders and diabetes

disorders, which are commonly associated with diabetes and CVDs. Expansion of this trial will allow testing

this NCE in a wider population, which is critical to the development of this drug and will provide therapeutic

solutions, not just to India but also to the rest of the world.”

EP News Bureau-Mumbai

iramal Enterprises has received approval from the US FDA for its Investigational New Drug (IND) P7435. This is a novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor.

P7435 has been developed by the NCE Research Division of PEL for the management of metabolic disorders such as lipid abnormalities and diabetes. It is wellestablished that increased lipid levels’ (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD). It has been reported by the World Health Organisation (WHO), that CVD, is the number one cause of deaths globally, representing approximately 30 per cent of all deaths. Currently, there is a significant medical need for effective and safe drugs for the management of lipid abnormalities and metabolic disorders.

P7435 has demonstrated its lipid lowering potential in various preclinical studies by showing significant reduction in triglyceride levels, glucose and insulin levels, and decrease in food intake and body weight gain –factors which are associated with lipid abnormalities and metabolic disorders.

PEL has established the safety and tolerability of P7435 in a Phase I trial recently completed in India.

This extension trial in the US will further evaluate the safety and efficacy of P7435 in a larger population.

Dr Swati Piramal, Vice Chairperson, Piramal Enterprises said, “The NCE Research division of PEL continues its ambitious diabetes/metabolic disorders programme to discover and develop NCEs to fight against diseases like diabetes and lipid disorders.

With P7435 we are looking at addressing a serious need for effective and well-tolerated drugs that treat lipid

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August 16-31, 2013

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M|A|R|K|E|T DEAL TRACKER

Increasing product pipelines in acute care environment drive M&A activity Witnesses no deals during July 2013 &A activity in the pharmaceutical sector was focused on strengthening complementary product portfolios, with antibacterial drugs being the area of focus, as bacterial diseases continue to present a major threat to human health.

In line with the above trend, Cubist Pharmaceuticals agreed to acquire Trius Therapeutics, a US-based biopharmaceutical company, for approximately $818 million.

This acquisition is a strategic fit for Cubist that supports its growth and long-range goals, while extending its global leadership in the acute care environment.

This transaction will provide Cubist access to a highly complementary, late-stage antibiotic drug candidate, tedizolid phosphate (TR-701), a novel oxazolidinone drug, which is being developed for both oral and intravenous (IV) administration in the potential treatment of acute bacterial skin and skin structure infections (ABSSSI). It is currently expected that a New Drug Application seeking approval for ABSSSI indication will be submitted to the US Food and Drug Administration (FDA) during the second half of 2013 and a Marketing Authorization Application will be submitted to the European Medicines Agency in the first half of 2014.

Further, Cubist also agreed to acquire Optimer Pharmaceuticals, a US-based biopharmaceutical company, for approximately $801 million. This transaction is also a natural fit for Cubist and is well aligned with its strategic goals. With this acquisition, Cubist will gain access to DIFICID, the first antibacterial drug approved in more than 25 years to treat Clostridium difficile-associated diarrhoea (CDAD) in adults of 18 years age or older. In another key deal in the month of July, Perrigo Company agreed to acquire Elan Corporation, an Ireland-based biotechnology company, for approximately $8.6 billion. This acquisition would strengthen Perrigo’s business and financial profile, with highly diversified revenue streams and enhanced cash flows. Also, this transaction creates an opportunity for substantial after-tax annual operating expense and tax savings of more than $150 million to Perrigo.

M&A activity in the pharma sector increased both in volume and value terms, when compared to the average of the previous six months (January – June 2013). According to Datamonitor’s Medtrack database, the pharma sector recorded 46 M&A transactions in July 2013, against the previous six months’ average of 31.6 transactions. In value terms, the sector recorded deals worth $12.5 billion against the previous six months’ average of $5.3 billion.

The Indian pharma sector witnessed no deals during July 2013, against the average of one deal over the previous six months.

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Figure: M&A (including private equity) trend analysis

Source:

Top M&A Deals (Jul 2013) Rank

Date

Target

Acquirer

Deal value ($m)

1

07/29/13

Elan Corporation, plc (IE)

Perrigo Company (US)

8600

2

07/30/13

Trius Therapeutics, Inc. (US)

Cubist Pharmaceuticals, Inc. (US)

818

3

07/30/13

Optimer Pharmaceuticals, Inc. (US)

Cubist Pharmaceuticals, Inc. (US)

801

4

07/28/13

Rockwood Holdings, Inc. - Rheology business (US)

ALTANA Group (DE)

635

5

07/24/13

Epax UK Holding III AS (GB) ; Epax Nutra Holding III AS (NO)

FMC Corporation (US)

345

6

07/12/13

Medicago, Inc. (CA)

Mitsubishi Tanabe Pharma Corporation (JP)

343.42

7

07/31/13

Ceptaris Therapeutics, Inc. (US)

Actelion US Holdings Company (US)

250

8

07/15/13

Syntaxin, Ltd. (GB)

Ipsen S.A. (FR)

206.53

9

07/17/13

Talon Therapeutics, Inc. (US)

Spectrum Pharmaceuticals, Inc. (US)

206.3

10

07/10/13

National Veterinary Services Limited (GB)

Patterson Companies, Inc. (US)

130.4

Source:

Figure: Venture financing trend analysis

Venture Funding Companies in the pharma sector raised $263 million during July 2013, against the previous six months’ average of $187.5 million. In terms of volume, the sector recorded 25 venture funded deals, when compared to the previous six months’ average of 19.5 transactions.

Notes and Definitions Source:

Top venture financing deals (July 2013) Rank

Date

Target

Investors

Deal value ($m)

1

07/29/13

aTyr Pharma, Inc. (US)

Alta Partners; Cardinal Partners; Domain Associates, L.L.C.; Polaris Venture Partners

49

2

07/18/13

Dermira, Inc. (US)

OrbiMed Advisors, LLC; 5AM Ventures; Versant Venture Management LLC

30

3

07/26/13

PolyTherics, Ltd. (GB)

Imperial Innovations; Invesco Perpetual; Mercia Fund Management Ltd; The Advantage Enterprise & Innovation Fund

20.7

4

07/02/13

Shenogen Pharma Group (CN)

Legend Capital; Qiming Weichuang Venture Capital Management (Shanghai) Company, Ltd.; Shenzhen Capital Group Co., Ltd.; Flybridge Capital Partners; China Investment Wealth Venture Fund; Lapam Venture

20

Foresite Capital Management, LLC; Mohr Davidow Ventures; Index Ventures; Undisclosed Investors

20

5

07/03/13

Sequenta, Inc. (US)

Definitions

Source:

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Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology.

It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

1.Deal value trend is based on transactions where associate values have been disclosed.

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

For more information, visit us at www.medtrack.com

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August 16-31, 2013

M|A|R|K|E|T

PRE EVENT BIORx launches BIO-Accelerator Programme Programme is devised for working executives, Ph.d scholars and postdoctoral scientists aspiring to accelerate the path of their discovery to marketplace

laboratory innovation into business success to contribute to India’s economy. NII, FITT and BIORx Venture Advisors are committed to support

India’s emerging bio-economy model by providing superior learning ecosystem in this regard.

Dr Chandrima Shaha,

Director, NII says, “NII is happy to associate itself as the technology partner in this initiative as we believe it will contribute significantly

towards creating awareness in translating laboratory leads into bioproducts and processes.”

EP News Bureau-Mumbai

IORx Venture Advisors (BIORx) has launched comprehensive master class on Bio-entrepreneurship with the theme, ‘Accelerating Innovations to marketplace – A small step towards strengthening India’s Bio-economy.’

Perceiving the acute need for enabling technologists to become successful business women/men in the life sciences sector, BIORx has designed this programme on bio-entrepreneurship.

This programme is devised for working executives, Ph.d scholars and post-doctoral scientists aspiring to accelerate the path of their discovery to marketplace.

BIORx has teamed up with National Institute of Immunology, NII, New Delhi, an autonomous institution of the Department of Biotechnology, Government of India, as a technology partner and Foundation of Innovation and Technology Transfer (FITT), as an incubation partner, to enable the successful execution of the research ideas to marketplace and recently signed up a tri-partite MoU to strengthen the ecosystem further to accelerate the commercialisation of the life sciences innovation.

BIORx has earlier conducted the first-ever master class on venture capital and private equity in life sciences under the aegis of BioAsia at Hyderabad, a global bio-business forum. The workshop was supported by Biotechnology Industry Research Assistance Council.

It was attended by 30 CEO/CTOs of various life sciences organisations including some foreign companies. The overall feedback by participants was very encouraging.

Vishal Gandhi, Managing Partner and Chief Executive Officer, BIORx considers this initiative as an effort aimed at not only bridging the industryacademia gap but also at helping technologists accelerate

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August 16-31, 2013

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EVENT BRIEF nd

2 Annual Nutraceuticals 2013 Forum Date: August 28-30, 2013 Venue: Holiday Inn International Airport, Mumbai Summary: UBM India will organise a strategic conference, 2nd Annual Nutraceuticals 2013 Forum, under Fi Brand by UBM.There will be a pre-conference regulatory seminar on August 28, 2013 focusing on domestic and global nutraceutical regulations.

will see 300+ exhibitors who will showcase the latest developments in packaging and processing on a floor space of over 1,40,000 sq. ft. (14,000 sq. mtrs).

Contact details: Intel Trade Fairs & Expositions 113, New Sonal Link Industrial Estate, Building No.2, Link Road, Malad (W), Mumbai - 400 064.

Maharashtra Tel: +91-22-26003977, 26003978 E mail: info@intelexpo.com

designed this programme on bio-entrepreneurship.

Contact details: Uttam Singh Negi Company Secretary BIORx Venture Advisors Tel: (0120) 6450521 Mob: 8130155022 Email: uttam.negi@biorxventures.com

Clinical Trials Asia Summit

Pharmac India 2013 Date: September 5-7, 2013 Venue: Hitex, Hyderabad Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and material exhibition, which is going to be held in Hyderabad, Hitex. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported

by BDMA and CIPI. Contact details: Varsha Surve.

Manager - Operations Exhibitions Orbitz Exhibitions 402, Navyug Industrial Estate, TJ Road, Sewri (W), Mumbai 400 015.

Tel: +91 22 2410 2801-03 | Fax: +91 22 2410 2805 | Cell: 09322037955. www.orbitzexhibitions.com /www.pharmacindia.com

Pharma Pack 2013 Date: September 12-14, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: Intel Trade Fairs & Expositions will organise the 13th Edition of Intelpack-2013

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PHARMAbiotika 2013 Date: September 16-18, 2013 Venue: Mahatma Mandir Convention and Exhibition Centre, Gandhinagar, Gujarat Summary: PHARMAbiotika is an exhibition and conference revolving around emerging challenges and trends in pharma, allied and clinical research related industry.This is the first time in India that an exhibition on Medical Tourism will be co located with PHARMAbiotika 2013.

Contact details: Atanu Bhattacharya Director Human Crayon Management Services C-28, Sector - 4 Noida - 201301, India Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: atanu@crayon4.com Website: www.pharmabiotika.com

Master Class on Bio-entrepreneurship Date: September 20-23, 2013 Venue: National Institute of Immunology, New Delhi Summary: BIORx Venture Advisors (BIORx) has launched comprehensive Master Class on Bio-entrepreneurship with the theme 'Accelerating Innovations to marketplace – A small step towards strengthening India’s Bio-economy.' Perceiving the acute need for enabling technologists to become successful business women/men in the life sciences sector, BIORx has

PharmaTech Expo 2013 Date: October 6-8, 2013

Summary: Clinical Trials Asia Summit is a platform for key stake holders to engage and critically analyse the road map for further growth towards establishing sustainable leadership of India in global clinical trials scenario.

Contact details: Tikenderjit Singh Makkar Dy Mktg. Manager India Fleming Gulf 605, City Tower Boat Club Road Pune - 411001 Maharashtra (India) Tel: (020) 67276403 Fax: (020) 6607 0061 Email: tikenderjit.singh@fleminggulf.com Website: www.fleminggulf.com URL: http://www.fleminggulf.com/conferenceview/Clinical-Trials-AsiaSummit-/485

16th PAC-2013

Venue: Brilliant Convention Centre, Indore Summary: PharmaTechnology Index.com and Indian Drug Manufacturers Association are jointly organising the second edition of PharmaTech Expo 2013 in association with Pharmexcil.

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 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol,Andheri (East) Mumbai - 400 059 T +91 22 61727162 F +91 22 61727273 E chaitali.patil@ubm.com

6th Symposium on Nasal and Pulmonary Drug Delivery

Date: December 20-22, 2013

Date: October 24-25 Venue: Hotel Novotel, Juhu, Mumbai

Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) have announced the 16th Pharmaceutical Analysts’ Convention (PAC) 2013.The main theme for this year’s convention is ‘Generics The Game Changer’. Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India New Delhi will be the Chief Guest.

Summary: The Indian Pharmaceutical Association announces the 6th Symposium on Nasal and Pulmonary Drug Delivery with a theme “Global Regulatory Trends”.The Symposium will be held in Mumbai, India on October 24th and 25th, 2013.

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: Prachi,Sr Manager Publications & PR,IDMA

Contact details: SD Joag Indian Pharmaceutical

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Date: December 3-5, 2013

Contact details: Keena Shah PharmaTechnologyIndex.com 702, Corporate House, Opp. Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009.

M: 09825698756 Ph.: 079-27541142 / 27540493 E-mail: kns@pharmatechnologyindex.com Website: www.pharmatechexpo.com

Date: September 27 - 28, 2013 Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai

Association Kalina, Santacruz (E) Mumbai-400 098 Phone No: 022 26671072 Telefax: 022 26670744 e-mail: ipacentre@ipapharma.org website: www.ipapharma.org

CPhI India

Date: September 26-27, 2013 Venue: Hyderabad

Contact Details: Shwetha Prabhu Tel: (022) 61727001 Email: conferencesindia@ubm.com

102-B, ‘A’ Wing, Poonam Chambers Dr Annie Besant Road, Worli Mumbai - 400018 Tel: (022) 24944624/ 24974308 (Extn. 103) Mob: 9867634383 Email: ppr@idmaindia.com/ prach17@gmail.com Website: www.idma-assn.org

65th IPC, 2013

Venue: Amity University, Noida Summary: Indian Pharmacy Graduates’ Association will host the 65th IPC, 2013 from December 20-22 this year.

Express Pharma has been chosen as the ‘Exclusive Official Media Partner’ for the 65th IPC, 2013.The event will be organised by Indian Pharmaceutical Congress Association.The academic partner for the event is Amity University, Noida.

Contact details: Dr Arun Garg General Secretary-IPGA Director-PDM College of Pharmacy, Bahadurgarh, Haryana Mob: 09416056213

August 16-31, 2013

M|A|R|K|E|T

PRE EVENT

Intelpack-2013: a must attend event Over 175+ exhibitors from across nine countries will showcase the latest in packaging technology at the event ntelpack-2013, a comprehensive exhibition on packaging will be held on September 12-14, 2013 at the Bombay Exhibition Centre, Mumbai. Organised on a floor space of over 1,15,000 sq ft,

by Intel Trade Fairs & Expositions, Intelpack- 2013 will be held in Hall VI of the Bombay Exhibition Centre. It promises to be the largest and the most comprehensive exhibition for the packaging industry with every sector of the packaging technology showcased by the exhibitors.

The event will witness 175+ exhibitors from over 200 companies and nine countries showcase the entire packaging supply chain.

Intelpack-2013 will offer the visitors with the opportunity to view what’s new, and learn how they can upgrade

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August 16-31, 2013

and make their packaging business more efficient. It will be a platform to connect with world-class companies whose top priority would be assisting its clients to find the right solution to make their business more efficient and

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dynamic. It would be the right place to discover the best solution to reduce costs and increase productivity. It's a chance to meet the entire packaging industry suppliers and service providers under one roof.

Intelpack-2013 will see several world class companies presenting their technology in India for the very first time.

Innovations, product launches, state-of-art solutions are all a part of the exhibition.

“Intelpack is one of our very successful exhibitions and I am extremely happy to share that we have the list of exhibitors that reads like who’s who from the packaging industry. With over 175 exhibitors and more than 250 products to see, Intelpack2013 is a must visit exhibition.

I believe, Intelpack-2013 will be a well attended show,” says Aditya Ashok, Head – Marketing & Sales, Intel Trade Fairs & Expositions.

Intelpack-2013 is a must attend event for every industry sector. It promises to open new doors of opportunity, be it getting to know who is active in the market, clinching best deals or simply browsing through the wide range of products.

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POST EVENT Local Organising Committee of 65th IPC felicitates Atul Kumar Nasa, President, IPCA In the run up to the 65th IPC in December this year, the IPCA held its second local organising committee meeting to felicitate its new President he second meeting of the Local Organising Committee (LOC) of the 65th Indian Pharmaceutical Congress (IPC) was recently held at Gurgaon, Haryana to felicitate the President of IPCA and also to discuss the progress of the preparation for this year’s event.

Indian Pharmaceutical Congress Association (IPCA) is a federation with five national pharma associations as its constituents viz: Indian Pharmaceutical Association (IPA), Indian Pharmacy Graduates' Association (IPGA), Indian Hospital Pharmacists' Association (IHPA), Association of Pharmaceutical Teachers of India (APTI) & All India Drugs Control Officers' Confederation (AIDCOC).

This year, the 65th IPC is to be hosted by IPGA and Atul Kumar Nasa, President, IPGA, has also been honoured with the prestigious position of President of Indian Pharmaceutical Congress

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Association (IPCA).

The meeting was organised in the run up to the 65th IPC 2013, scheduled to be held from December 20-22 at Amity University Campus, Noida, Delhi NCR. The event saw participation from around 30 members of different task committees.

RC Juneja, Chief Executive Officer and Chairman, Mankind Pharma, also the Chairman of the LOC of 65th IPC, delivered the inaugural note to the audience, thanking them for their cooperation. He said, “The purpose of IPC is to ensure empowerment of Indian pharma companies. It is a big achievement for all of us to move ahead towards this.”

AK Nasa, who has now taken over as President of IPCA, thanked all the members for giving him the opportunity to serve the profession by holding the prestigious position as President of IPCA. “I was associated with the 53rd IPC (2001) and 60th IPC (2008), held at Delhi as an Organising Secretary and both the conferences were benchmark conferences appreciated by everyone. I would request all members to

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extend their support for the success of 65th Indian Pharmaceutical Congress,” he said. He expressed that the 65th IPC will be different one from the past conferences, helping bring about a definite change in the national policies and thereby empowering pharmacists.

Dr Arun Garg, Organising Secretary, LOC, 65th IPC, gave a presentation about the progress of this year’s event.

The theme of the conference is Pharma Vision 2020: Empowering Pharmacists. As the title suggests, the conference would deliberate on the development of pharmaceutical sciences, new drug development, R&D and their future.

Federation of Indian Chambers of Commerce and Industry (FICCI) will be the exhibition partner and it is expected that more than 300 exhibitors from various countries will be participating. Express Pharma will be the media partner for the conference and yatra.com will be the travel partner. He explained the duties and responsibilities of various task committees.

Prof Dr SS Agarwal, Advisor and Chairman

of Scientific Services Committee, thanked Dr Ashok Kumar Chauhan, Founder President, Amity Group of Institution for his support. He added that this year the scientific sessions will be technically based and some noble laureates will be delivering their talk. BR Sikri, Advisor and Chairman of Finance Committee also requested all members to support the 65th IPC. Later on, the chairpersons of different task committees including key committees like registration, inauguration, volunteers, entertainment, press and publicity, accommodation, venue, transport, exhibition, reception, security, ladies hospitality etc., presented their views and discussed the progress of their respective committees. The meeting ended with the vote of the thanks by Dr Garg to the President, Chairman-LOC and all other members.

In the evening there was a felicitation ceremony for Nasa, the IPCA President. It was attended by more than 100 members along with their families.

EP News Bureau-Mumbai

August 16-31, 2013

MANAGEMENT INSIGHT FOR MANAGING PHARMA

W H AT ’ S INSIDE

US Supreme Court squares off on human gene patentability PG 38

MARKET 15 RESEARCH 39 LAB NEXT SPECIAL 41 PHARMA TECHNOLOGY REVIEW 45 PHARMA LIFE 79 August 16-31, 2013

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T The Ministry of Health and Family Welfare (MoHFW) India issued a notification on June 18, announcing the suspension of manufacture for sale and distribution of oral anti-diabetes drug pioglitazone and all the formulations containing it for human use in India. It came as an unwelcome surprise to not only the pharma companies who were manufacturing or marketing the drugs but also for medical professionals who were prescribing it on a day to day basis and last but not the least, the diabetic patients who are on pioglitazone medication. To challenge the ban, medical experts in association with patients, pharma stakeholders and diabetologists came together and made propioglitazone representations to the MoHFW and after speculations on these arguments, the ministry revoked the ban

DR RAJIV KOVIL

DR A K SINGH

Founder Member, United Diabetes Forum, Dr Kovil's Diabetes Care Centres

Consultant Endocrinologist and Diabetologist, GD Hospital and Diabetes Institute, Kolkata and Sun Valley Hospital and Diabetes Research Center

Every one who resisted the ban believed that the drug has a lot of value, especially in India where it is a cheap drug with a long durable action

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I believe that physicians must use it very judiciously and not rampantly as it was used earlier

DR BANSHI SABOO

DAARA B PATEL

Fellow - American College of Endocrinology, Diabetologist and Endocrine Physicians

Secretary-General, Indian Drug Manufacturers' Association (IDMA)

I am very glad that the drug is available again in the market

All is well that ends well!

It is the responsibility of the DCGI to protect patients, not profits and sales of the pharma industry

officially on July 31, but with cautionary mandatory guidelines on each pack.

The news of the revocation of the ban on pioglitazone was a cause for celebration for many. Responding to the announcement, Dr Rajiv Kovil, Founder Member, United Diabetes Forum, Dr Kovil's Diabetes Care Centres says, “This decision will bring a smile back on the face of 30 lakh patients who are using the drug. Diabetes specialists across the country believed that pioglitazone is a nuclear level good molecule which when used judiciously can produce excellent results. It is a victory for science which brings the patient-doctor relationship much closer. This saga and red box warning will ensure the judicious use of pioglitazone and all molecules in the chronic care segment, thus ensuring transparency and evidence-based practice.”

Dr A K Singh, Consultant Endocrinologist and Diabetologist, GD Hospital and Diabetes Institute, Kolkata and Sun Valley Hospital and Diabetes Research Center expresses, “I am happy that the pioglitazone ban has been revoked officially through notification in the Indian Gazette Extraordinary dated July 31.

Now it will help all of us to control and manage diabetes effectively.”

V Mohan. Kovil informs, “France had banned pioglitazone in June 2011 and there were no fresh new evidences to ban it since then, hence it came as a surprise. Majority of diabetologists across the country believed that the Government of India (GoI) had taken a knee jerk reaction and hence made their protest evident through media, social media, petitions and also RTI. There was anger, anguish and despair among patients and doctors across the country when the ban on pioglitazone was announced.”

Daara B Patel, SecretaryGeneral, Indian Drug Manufacturers' Association (IDMA) reveals the steps taken by the association against the ban and says, “In our representation submitted to Drug Controller General India (DCG(I)) earlier requesting them not to suspend the drug, we have highlighted a few studies conducted internationally which point out that the side-effects associated with pioglitazone, such as bladder cancer, was not significant and that there are too few events of bladder cancer reported. However, despite this, leading regulatory agencies such as US FDA, UK MHRA, Japan PMDA and Australia TGA have persisted with its availability in view of its immense need for managing Type II diabetes mellitus (T2DM). The reasons have been based on firm scientific evaluation of the same based on factual evidence.”

Singh agrees with the drug's side effects and informs, “It is well known fact that any drug administered to a patient will have a side effect. Pioglitazone does have some side effect like pedal

edema, macular edema and propensity to aggravate latent heart failure. It can also aggravate osteoporosis and incidental fractures in postmenopausal women and therefore needs caution. An astute physician will choose the right patient for a given therapy to avoid the side effects.”

Why was pioglitazone banned in the first place?

The Health Ministry's decision to ban the manufacturing and sale of pioglitazone drug was reportedly due to its ban in France in 2011 on account of its associated risk of bladder cancer and a report by a Chennai-based doctor, Dr www.expresspharmaonline.com

DR CHANDRA M GULHATI Editor, MIMS

Risk vs acceptability Dr Chandra M Gulhati, Editor, MIMS imparts more information on the pioglitazone ban and highlights, “The notification (of June 18) had merely stated that continued marketing of pioglitazone can harm the patient. And the ministry has not given any reasoning for 'suspension' of marketing authorisation.

There must have been very good reasons to suspend the manufacture, distribution and sale of pioglitazone. The Ministry has 'not suggested to switch to another treatment methodology'."

Patel points out, “For any new product, clinical trials are necessarily being carried out to test the drug on Indians even though the drug has been found to be efficacious in overseas market and has a history of use!” He also stated that in this context pioglitazone's use should be permitted for the benefit of Indian diabetes patients unless the evidence of its cancer concerns far outweighs its utility.

He further added, “It thus seems irrational that even in the absence of relevant data on Indians, the Health Authority considered suspending pioglitazone, based on just one European country (Republic of France) – that too whose health regulatory agency (AFSSAPS) had stated August 16-31, 2013

M|A|N|A|G|E|M|E|N|T

in June 2011 that it was banning pioglitazone since the 'population of its country particularly had shown an unusual associated risk of bladder cancer with the use of this drug'.

Hence, such a premature attempt at prohibiting pioglitazone's availability in the Indian market was grossly unjustifiable, not only for the consumer but even for the pharma industry which would suffer a setback to the tune of over ` 550 crores (annually as per ORG, March 2012 – India).”

While recalling the DCGI's responsibilities and duties, Gulhati queries, “It is the responsibility of the DCGI to protect patients, not profits and sales of the pharma industry.

Pioglitazone is one of the many antidiabetic agents and there are so many other drugs for diabetes. If patients in France and German can survive without pioglitazone, so can people of India. Why should a patient be treated with a drug that can cause bladder cancer?”

Singh disagrees with the government's opinion and counter-argues, “If the insubstantial association of bladder cancer is the reason for banning pioglitazone then all existing anti-diabetic agents (except metformin,) including insulin, sulfonylureas (SUs), and incretin-based therapies should be withdrawn or banned as well because of their unsubstantial associations with cancer. All current major international guidelines, including ADA/EASD (2012) and IDF (2012) recommends pioglitazone as a second line drug after metformin.”

He continues and informs about the drug's side effects and suggests, “When everything hinges on the riskbenefit ratio, it is tilted heavily in favour of pioglitazone. The number of patients required to be exposed to pioglitazone to cause one bladder cancer is very high when compared to the number of deaths prevented by its meticulous use. I believe that physicians must use it very judiciously and not rampantly as it was used earlier. It should be used in the lowest effective dosage whenever applicable and must not exceed doses of more than 30 mg/day. Everybody should be aware about the 'Red Box warning' associated with its use and always remain pharmacovigilant about all the side effects.”

Why India needs pioglitazone Pioglitazone is a preferred drug for diabetes treatment as it is the cheapest drug available in the Indian market. According to the ORG 2012 data, the consumption of pioglitazone in India alone is 2,84,81,000 units and its combinations is 8,97,90,000 units annually. This translates into approximately 3.25 lakhs patients consuming pioglitazone/-based combinations every day of the year! Informing about the availability of pioglitazone with its price variation in the Indian market, Singh says, “For a month's treatment, pioglitazone nearly costs `120-150 as compared to other oral August 16-31, 2013

drugs like gliptins which cost ` 1200 1300 for a month or injectable GLP-1 analogues that cost ` 4000-4200 per month. It is an effective oral drug and banning this drug obviously would lead to much increased utilisation of either gliptins or GLP-1 analogues, incretin-based therapies (long term safety still unproven apart from being costly) or insulin (injections, regular monitoring, complex regime). Today lakhs of Indian diabetic patients are on pioglitazone treatment with no untoward effects.”

Patel points out, “Discontinuing pioglitazone can result in unwarranted poor hypoglycemic control, leading to more defined health related concerns in Indians, with India already recognised to have the largest population of diabetics, This evidently implies that the medical profession is more dependent on pioglitazone (and combinations) for managing their T2DM Indian patients. ” Dr Banshi Saboo, Fellow American College of Endocrinology, Diabetologist and Endocrine Physicians opines, “The sudden ban left us with no options at all and patients, as an alternative, had to be put on gliptins or insulin to help control their diabetes. It caused a sense of dilemma and mistrust in the minds of the patients as to why did their doctor prescribe them a drug with such a dangerous side effect. For the patients from the unaffordable category it was even more difficult as gliptins and insulin are costlier than pioglitazone.

It left our patients with uncontrolled blood sugar levels and anxiety. The upliftment of the ban from the drug has been a relief overall. I am very glad that the drug is available again in the market.”

Kovil emphasises, “Every one who resisted the ban believed that the drug has a lot of value, especially in India where it is a cheap drug with a long durable action.”

Pharmacovigilance: a needed step Gulhati informs, “Tracking hitherto unknown side effects of marketed drugs is an extremely tedious, time consuming, expensive and elaborate exercise. Depending on drug manufacturers, with obvious conflict of interest, to report adverse drug reactions (ADRs) on their own products is unwise. Experience in the past has taught that depending on spontaneous reporting of side effects by physicians, pharmacists, nurses etc. is not adequate. Even in the US, not more than 10 per cent side effects are reported spontaneously. The answer lies in large scale, controlled, phase IV trials focused on identifying side effects. There has to be an independent mechanism in place, run and managed by academic institutions with no biased interest. This is the only way forward. “ He continues, “The current pharmacovigilance (PV) programme in India is ineffective. As of date there is no way except drawing on the experiwww.expresspharmaonline.com

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ence and reports of side effects and regulatory action taken by advanced countries.

The MoHFW has correctly taken a decision to suspend marketing of drugs which are prohibited in specified developed nations viz US, Britain, Canada, EU, Australia and Japan.” (More details of the challenges facing India’s PV framework are in the story, ‘Pharmacovigilance: Is India losing the way?’, pages 15-21 of this issue)

Media's role

promoting an alternative to pioglitazone. Patel also states that probably it was the first time that our health authorities took such a drastic step without seeking industry’s views or at least consulting the medical fraternity who prescribe this medicine regularly. Any concern of the regulatory/health authorities pertaining to pioglitazone could always have been discussed and debated with concerned stakeholders as well as with practicing medical professionals, relevant medical experts

Patel enlightens that Dr V Mohan, the doctor who authored the report based on which pioglitazone was banned, had vested interests for favouring the ban. He says that as per many newspaper reports, Dr Mohan’s Diabetes Specialties Centre, Chennai was apparently being supported by an MNC who could have had a vested interest in

Further steps required

Major countries where pioglitazone is sold Sr. No.

Name of Country

Launch date

Remarks

No. of years

1

USA

1999

13

2

Japan

1999

13

3

UK

2000

12

4

Switzerland

2000

12

5

Canada

2000

12

6

Austria

2000

12

7

Denmark

2000

12

8

Mexico

2000

Approval date

12

9

Thailand

2000

Approval date

12

10

Australia

2001

11

11

Italy

2001

11

12

Spain

2001

11

13

HongKong

2001

11

14

New Zealand

2001

11

15

Philippines

2002

10

16

Finland

2002

Approval date

10

17

Belgium

2003

Approval date

9

18

South Korea

2003

9

19

China

2004

8

20

Ireland

2006

6

21

Malaysia

2006

6

22

South Africa

2007

Approval date

23

Brazil

Available

Launch date not known

24

Argentina

Available

Launch date not known

25

Chile

Available

Launch date not known

26

Czech Republic

Available

Launch date not known

27

Greece

Available

Launch date not known

28

Norway

Available

29

Portugal

30

5

Regulatory body of France has taken cognizance of a cohort study by the Kaiser Permanente Northern California (KPNC), which included around 190,000 patients, and showed an increased risk of bladder cancer with pioglitazone exposure for >24 months.

However, after adjusting for age, sex and use of other glucose lowering drugs, the association between pioglitazone use and bladder cancer was not significant. Singh suggests, “Physicians must use pioglitazone judiciously in selected cases where it is indicated, preferably not as first or second line agent. Patients with heart failure, osteoporosis and at risk of developing macular edema should not be given pioglitazone. The lower dose of pioglitazone, in combination therapy, could be equally effective and may be used to avoid any cumulative long term risk. We must remain pharmacovigilant.

MoHFW, DTBA, DCGI, Journal of the Association of Physicians of India (JAPI) and Association of Physician of India (API) should take lead in increasing awareness.

Currently we may put a 'black box warning' about these potential side effects to make both patients and doctors aware. However, it is too harsh to ban a potential beneficial drug in diabetes on this unknown and unsubstantiated bladder cancer risk!”

Commenting on the government’s further steps before banning any drugs in India, Gulhati says, “Industry has obvious conflict of interest.

Would it ever advocate a ban?

As far as experts are concerned, the number needs to be much larger than current levels of a few that can be counted on finger tips. Besides the process of selection of experts has to be transparent.

The parliamentary committee has named and shamed many "eminent experts" from medical colleges and hospitals who have merely signed ghost recommendations drafted by drug manufacturers in support of their products. Moreover, even honest experts can only comment on data that is generated abroad. Personal opinions of experts without credible, transparent data and evidence in support of such opinions is of limited use. Unless original, independent, credible data on ADRs is generated in India, there is no practical alternative to mainly depending on data generated abroad in the decision making process.

Patel quips, “Alls well that ends well! It is now learnt that the DTAB, in the meeting on July 19, has endorsed our suggestions and recommended to the Government to revoke the ban. We also understand the Board has recommended that the drug carry a box warning on the possible risk of bladder cancer.” The argument continues but the fact remains that any step taken should ultimately benefit the patient. It also goes without saying that we need to be more pharmacovigilant and that patients should be kept in the loop about the side effects of any medication consumed by them. u.sharma@expressindia.com

Year since pioglitazone formulations are marketed in India Launched

Molecule

Launch date not known

Mar-01

PIOGLITAZONE

Available

Launch date not known

Feb-01

PIOGLITAZ.+ METFORMIN

Russia

Available

Launch date not known

Dec-02

PIOGLITAZ.+ GLIMEPRIDE

31

Sweden

Available

Launch date not known

32

Venezuela

Available

Launch date not known

Dec-03

PIOGLITAZ.+METFORM.+GLIM.

(Source: Indian Pharmaceutical Alliance (IPA))

(Sources: Indian Pharmaceutical Alliance (IPA))

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and the pharma industry’s representatives.

However Gulhati states that MoHFW had no hidden agenda behind banning pioglitazone. He asks, “A decade ago USV's phenformin was banned, was it to hurt USV? Besides, both Sun Pharma and Lupin market pioglitazone under the brand names of Pioglit and Path. So, how can they be benefited by banning their brands? To even think that the health ministry's move is meant to help certain drug companies is beyond belief. It is the direct fallout of media coverage and 59th report of the parliamentary committee on health, which castigated DCGI for dancing to the tune of the drug industry at the cost of the welfare of patients. It is the statutory duty of DCGI to protect the interest of patients.”

EXPRESS PHARMA

www.expresspharmaonline.com

August 16-31, 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:

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LEGAL EAGLE US Supreme Court squares off on human gene patentability Smriti Subramanian, Partner, and Anumeha Iyer, Associate, Advaya Legal dissect the split legal outcome of the decision by the US Supreme Court in the Myriad-AMP and discuss its implications on the legality of gene patents in India he US Supreme Court delivered its much anticipated judgment in the Myriad case (Association for Molecular Pathology vs.

Myriad Genetics) on June 13, 2013 putting an end to the generally accepted USPTO practice, and overruling what appeared to be settled since the Court’s landmark decision in Diamond vs Chakrabarty – the patentability of human genes.

For three decades, the United States Patent and Trademark Office or USPTO had awarded patents on naturally-occurring human genes. But those patents have been rejected by nine justices who unanimously ruled that companies cannot patent parts of naturallyoccurring human genes, but afforded legal protection to synthetically produced genetic material under extant patent laws.

In a decision with both immediate benefits for some cancer patients as well as seemingly long-lasting repercussions for biotechnology research, the apex court found that human DNA sequences were a ‘product of nature’. As such, the Court concluded that merely isolating a gene from its surrounding genetic material cannot be deemed an invention or a technological discovery and accordingly, the same did not qualify for patent protection.

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Anumeha Iyer, Associate, Advaya Legal

Smriti Subramanian Partner, Advaya Legal

Background Association for Molecular Pathology vs.

Myriad Genetics1 was a significant case challenging the validity of gene patents in the US, specifically challenging certain claims in issued patents, jointly owned/controlled by Myriad Genetics along with the University of Utah Research Foundation, that covered isolated DNA sequences, methods to diagnose propensity to can-

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cer through mutated genetic codes, and methods to identify drugs using such isolated DNA sequences for cure.

Prior to the case, the USPTO accepted patents on isolated DNA sequences as a composition of matter.

Gene patents in India The legality of gene patents has long been a bone of contention. On one hand, it may be argued that the isolation of a gene amounts to ‘discovery’ and not ‘invention’ and hence the same is not patentable.

On the other hand, it may also be asserted that the subject matter is not the isolated gene per se but the purified gene which comes under the realm of ‘invention’ and therefore, patentable. The question as to whether a purified gene is a part of the human body remains moot.

Under the present Indian patent regime, ‘naturally occurring’ human genes cannot per se be patented but when modified with significant human intervention coupled with industrial applicability, they are considered a valid patentable subject matter under the Patents Act, 1970. Further, the Draft Manual of Patent Practice and Procedure, 2008 prescribes that diagnostic methods employing DNA are patentable to the extent the same is performed on tissues or fluids which have been permanently removed from the body.

Implications of the decision As a result of the ruling, the Court struck down patents held by Utah-based biotechnology company, Myriad Genetics on a pair of genes linked to increased risk of breast and ovarian cancer, namely BRCA1 and BRCA2.

Myriad's patents on BRCA genes made testing www.expresspharmaonline.com

for them its monopoly. The company's breast cancer gene test was recently brought into the public eye by Hollywood actress, Angelina Jolie, who revealed that she had undergone a preventive double mastectomy procedure after learning that she herself carried a defective BRCA1 gene which put her at high risk for developing breast and ovarian cancer. The actress who lost her mother and grandmother to ovarian cancer openly acknowledged that BRCA testing was rather expensive.

Gene patents claim underlying fundamental information about genetic behaviour which is pertinent for both upstream and downstream research activities. The very nature of gatekeeper patents mandates that all uses of the gene, including gene therapy and other pharmacological modulations, must go through the original gene patentee before any invention pertaining to such gene is practiced. Such patents can therefore easily acquire the character of ‘blocking’ patents which can have an ‘anti-commons’ effect on the society.

This split legal outcome is representative a victory for cancer patients, researchers and physicians who have claimed that a single company's patent raised costs, restricted research and sometimes forced women to have breasts or ovaries removed without sufficient facts or second opinions. Myriad itself emphasised the bright side of the decision for the company – that complementary DNA or cDNA, which is not naturally occurring, remains patentable, as a result of which, it said, 24 patents containing more than 500 valid claims remain in effect. Moreover, what appears to be the most significant positive outcome of such a decision is that the cost of breast and ovarian cancer testing has fallen, thereby making it more easily available to lowerincome groups or those lacking quality health

insurance.

However, the more conservative justices have criticised the decision pronounced by Justice Clarence Thomas, and regarded it as a complete denial of patent rights, which could potentially jeopardise investments by other biotechnology companies, and in turn limit progress on a range of research. Genetic research is a fairly young science whose full potential is yet to be tapped. A legal framework protecting gene patents would promote and accelerate clinical research in this niche, as it would assure investors participating in such high-risk activities of a decent return from commercialisation of their research output.

While genes are certainly a product of nature, the isolation of fragments and knowledge of their properties are the outcome of the huge financial and material resources invested with its attendant risks, whose importance cannot be denied.

Another major drawback of the said decision to bar gene patents is that it would also mean that researchers — who discover human gene sequences responsible for a particular disease — do not have necessary incentive to disclose the new discovery. This indirect and unintended bar on public disclosure is a major shortcoming that encroaches upon public welfare.

Similarly, scientific exploration activities for new and rare organisms that have incredible economic value, which could be in hostile areas like the bottom of the oceans or the edge of a volcano, will also get a setback as the inability to patent the genome makes such projects unfeasible.

In light of this decision, it would be worthwhile for players in the global biotechnology industry to review their existing patents portfolio as also re-allocate spending in research and development initiatives.

Reference 1 569 U.S. 12-398 (2013) August 16-31, 2013

RESEARCH UPDATES

Regulators pave way for dissimilar drug breakthrough

London/ Zurich uropean regulators have cleared the way for the first serious threat to the makers of multibillion-dollar biotechnology drugs to treat diseases such as cancer and rheumatoid arthritis. The European Medicines Agency (EMA) said that its experts had backed approval of two copycat versions of Johnson & Johnson and Merck & Co's blockbuster rheumatoid arthritis drug Remicade, the first time a green light has been given for such antibody-based medicines. Until now, complex biotechnology medicines such as Remicade given by injection or infusion have been largely immune from generic competition, unlike conventional pills.

But the EMA’s announcement on so-called biosimilars Remsima and Inflectra, made by South Korea's Celltrion and U.S. company Hospira respectively, signals the changing landscape as regulators set out a clearer path for the evidence needed to secure approval of such products.

Celltrion executive Kim Hyoung-ki told reporters that the company is planning to seek approval in Japan later this year and that an application for US approval is possible in 2015.

He said that the company expects to sell Remsima at a 30 per cent dis-

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August 16-31, 2013

count to Remicade, aiming to win a significant chunk of the $6.1 billion sales that the drug racked up for Johnson & Johnson in 2012.

Celltrion also aims to boost sales further with approval in emerging markets and recession-hit countries such as Greece. Citi analyst Andrew Baum said that European regulators' backing of biosimilar versions of Remicade is also likely increase the perceived risk for Roche's top-selling cancer drugs Rituxan and Herceptin. Roche is trying to protect its existing products by bringing out improved, patented versions of its medicines. Both Remsima and Inflectra have been recommended for a range of auto-immune diseases, including rheumatoid arthritis, Crohn's disease and psoriasis among others.

Europe has already approved some simpler biosimilars, including copycat versions of human growth hormone and the anemia treatment EPO, but it has yet to approve an antibody drug such as Remicade, which is known generically as infliximab. Unlike traditional chemical drugs, biotech medicines consist of proteins derived from living organisms that cannot be replicated exactly. Biosimilars, therefore, are more difficult to develop and need more tests to prove they work properly.

Reuters www.expresspharmaonline.com

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FDA rejects Merck insomnia drug, seeks lower-dose US health regulators have rejected Merck & Co's new insomnia drug application but opened the door to approving a lower-dose version of the medication, the company said erck said it received a complete response letter from the US Food and Drug Administration saying that the agency could consider a 10 milligram starting dose of suvorexant for most patients, but that the company would have to have that dosage ready before it could be approved. The FDA in its letter said 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective, Merck said.

M

ISI Group analyst Mark Schoenebaum said the manufacturing study could lead to about a one-year delay in approval, especially if the FDA asks for long-term stability testing of the lower dose version.

Merck declined to discuss the timeline or potential length of delay as a result of the FDA response.

Merck had proposed that elderly patients start by taking 15 milligrams of the drug and increase that to 30 if necessary, and had recommended that non-elderly adults start on 20 milligrams and increase to 40 milligrams if needed. In its letter, the FDA determined that doses of 30 mg and 40 mg were not safe for approval, Merck said. Merck said it

doesn't see the need for further clinical studies to move forward with a 10 mg dose, but would require manufacturing studies to move ahead. Such manufacturing studies typically involve development of standard manufacturing and operational procedures to demonstrate that the pill can be manufactured in a stable and reproducible form. It could also require demonstrating that the medicine has a durable shelf life. “We know how to do this. We do this all the time,� Merck spokesman Steven Cragle said. ISI's Schoenebaum, who forecast annual suvorexant sales of $700 million by 2018, in a research note estimated a modest impact to Merck

from the delay, and found a silver lining in that "suvorexant at 15 mg and 20 mg doses appears to the FDA to be approvable."

He said a one-year delay lowers ISI's 2018 Merck EPS estimate by only 0.25 per cent to 0.6 per cent. Merck also said it will discuss with the FDA whether additional studies will be required to support a 5 mg dose for certain patients. Suvorexant belongs to a new class of insomnia medicines called orexin receptor antagonists and would be the first such medicine on the market if approved. It is designed to facilitate sleep by blocking neurotransmitters in the brain that help to keep a person awake.

Reuters

Bayer enters cancer research deal with Compugen Frankfurt/ Jerusalem erman pharmaceuticals company Bayer has entered a new cancer partnership with Israel’s Compugen to research, develop and commercialise antibody-based therapies.

The two partners will jointly carry out a preclinical research programme. Under the deal, Compugen will receive an upfront payment of $10 million, and is eligible

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to receive over $500 million in potential milestone payments. Compugen may also receive mid to high single digit royalties on worldwide net sales of any resulting products under the collaboration.

"Antibody-based immunotherapies are promising approaches in oncology which can stimulate the body's own immune cells to fight cancer cells," Bayer executive Andreas Busch

said. Bayer will have full control over further development and have global commercialisation rights for potential cancer therapies.

The immunotherapy approach aims at combating cancer by stimulating the body's own immune cells. The tumour and its environment suppress the ability of cancer patients to develop an effective antitumour immune response and in this way protect both tumour growth and survival.

Compugen said it has discovered two novel immune checkpoint regulators that potentially play a key role in immunosuppression and researchers at Compugen are developing specific therapeutic antibodies that are geared to block the immunosuppressive function of these targets and to reactivate the patient's anti-tumour immune response in order to fight cancer Reuters

Novartis drug does not show survival benefit in liver cancer Zurich wiss drugmaker Novartis said its drug Afinitor did not show a survival benefit in patients with advanced liver cancer. Data from a late-stage trial found that Afinitor did not extend overall survival compared to placebo in patients with locally advanced or metastatic hepatocellular carcinoma (HCC) after progression on or intolerance to another drug sorafinib.

"While we are disappointed with these results, Novartis remains committed to study-

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ing everolimus through a robust research and development program to address unmet needs in different types of cancer," said Alessandro Riva, Global Head of Oncology Development and Medical Affairs at Novartis Oncology.

Afinitor is already approved in the US and Europe for the treatment of advanced renal cell carcinoma. It is also approved in Europe for postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

Reuters www.expresspharmaonline.com

August 16-31, 2013

LAB NEXT Special INSIGHT Crystallisation tools for the research chemist Dr Jasbir Singh, Founder and Managing Director, HEL, gives an outlook about the crystallisation tools for the research chemist

he need to study crystallisation is extremely widespread in the chemical industry due to the importance of solids as the final form of many products.

The most basic information required is the solubility of crystals – proceeding without this basic information is like trying to locate a house without knowing the address – it can be done but will take a long time.

When the crystallisation is to be scaled up into a process, you also need the socalled metastable zone width (MSZW). MSZW is important in crystallisation processing as it represents the difference between the saturation temperature and the temperature during cooling at which crystallisation actually commences. – essentially a road map of the temperature region over which the crystallisation process will be run. During research, knowledge of these parameters is needed at a range of concentrations for common solvents and solvent mixtures.

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CrystalEYES – A basic tool When crystals are added August 16-31, 2013

to a solvent and heated, the solution will become clear when the crystals have dissolved; as it is cooled down again the crystals will reappear. The point at which these two events occur can be estimated by simply looking into the vessel and noting the relevant temperatures – a procedure that is likely to be time consuming and unreliable.

A simple but effective alternative is to insert a turbidity probe in the vessel and this will reproducibly do the same job. If these measurements can be integrated with temperature, and the data is automatically recorded, then of course you have the ideal system.

This is in fact exactly what crystalEYES does – it records temperature and turbidity to give the solubility and MSZW for the solvent and crystals being studied – it is linked to a PC with preloaded software so the information is captured without effort. This can be hooked on to existing stirred reactors or simply vials on hot plates to record the necessary data. CrystalEYES is also records pH if necessary, as this can sometimes affect solubility. Typical data is shown in Figure 1 below – this is a screen shot of the live data display as you heat and cool a mixture.

If this cycle is repeated at different concentrations this will give the all the necessary information for that crystal/solvent combination and the classic plot shown in Figure 2 can be generated.

CrystalEYES basically consists of temperature and turbidity probes plugged into a signal conditioning unit which in turns is connected to a PC. The system comes ready to run – all that needs to be decided is the size of the probes. Different interchangeable probes can

W H AT ’ S INSIDE

Viral contamination: Detection and removal PG 42 Encapsulation and spray drying solutions by BUCHI PG 44

Figure 1. Typical data from CrytalEYES

Figure 2. Metastable zone width (MSZW) plot

Figure 3. Typical data from CrystalSCAN with successive dilutions

Figure 4. Comparison of result with literature Continued on Pg 44 www.expresspharmaonline.com

MARKET 15 MANAGEMENT 33 RESEARCH 39 PHARMA TECHNOLOGY REVIEW 45 PHARMA LIFE 79 EXPRESS PHARMA

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Viral contamination: Detection and removal Many bio-manufacturing processes use animal-derived starting materials, which raises the risk of viral contamination. It is essential that any such viruses are detected, and either removed or inactivated from the final product, as Kate Smith, Principal Scientist in Development Services at BioReliance, explains he potential for vaccines and other biological pharmaceutical products to be contaminated with viruses has been known for decades. Awareness goes right back to the early days of the polio vaccine, more than half a century ago, when early versions of the life-saving vaccine were contaminated with simian virus-40 (SV-40) from infected rhesus monkey kidney cells. There have been numerous instances since then, some more serious than others, and even some that have led to manufacturing facilities being closed down for long periods of time for decontamination.

Any manufacturing process that relies on starting materials from an animal source can be contaminated with viruses. Many biological drugs are made via cell culture, typically using Chinese Hamster Ovary (CHO) cells or murine cells, and these cells invariably (and unavoidably) contain endogenous viral contaminants. While these viruses may have no health effects in humans, their presence in final drug products is far from ideal. Similarly, the use of media that contain components from animal sources, such as serum, can cause viral contamination of a product.

Human plasma is another potential source of viral contamination. Blood donations are screened, but there is rarely time to carry out full viral analyses to test for the presence of viral contaminants before they are used.

Instead, companies who use blood-derived materials in their processes rely on donor screening programmes to minimise the chance of dangerous viruses such as HIV or Hepatitis B and C inadvertently being passed on to patients via drug products.

Starting materials are not the only source of viral contamination, however. Any raw material that is used in a process, regardless of its source, could potentially be contaminated with a virus.

There is also the possibility that viral contaminants could enter the manufacturing process from a human operator within the facility.

The impact of viral con-

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tamination can be enormous.

The SV-40 present in early polio vaccine led to a widespread distrust of the vaccine, and it remains unclear today whether the inadvertent infection of recipients has had long-term health effects. The headline-hitting vesivirus contamination at Genzyme’s manufacturing facility in Boston in 2009 led to shortages of two drugs to treat rare conditions, Cerezyme for Gaucher’s disease and Fabrazyme for Fabry’s disease, while the facility was closed for months as it was being decontaminated. In addition, the detection of porcine circovirus in both GSK and Merck’s rotavirus vaccines led to brief product suspensions, before FDA declared that there is no risk to human health from either virus and allowed the vaccines to be used again.

These incidents highlight the importance of continual testing for viruses during a biological product’s manufacture process and throughout its lifecycle, as it becomes possible to detect new viruses. Even if there is no health risk, viruses should be inactivated or removed from final drug products, if at all possible.

known to be susceptible to human viruses. The choice is dependent on the potential contaminants; either as endogenous contaminants or from the way the cells are handled.

Some viruses will not grow in in vitro assays, and therefore in vivo tests must be used to check for these.

Again, the species chosen will depend on the nature and source of the cells being used in the biomanufacturing process. As with any procedures using animals, these tests must be carefully controlled.

Other tests can also be employed. Notably, retrovirus can be detected using electron microscopy or reverse transcriptase assays. Those viruses that are typically present in rodent cell lines can also be detected using antibody production tests. Massively parallel sequencing is a relatively new technique that is now becoming established in the field. While it is not intended for routine quality control use, it does allow detailed studies to be made on raw materials.

Once potential viral contaminants have been identified, the results can be used to develop specific Polymerase Chain Reaction (PCR) tests for routine QC use.

Managing the risk Screening is the initial defence against viral contamination. The regulators have clear rules about the required testing procedures necessary for all cell lines and other raw materials that are used in biomanufacturing processes.

While this is a time-consuming process – the full characterisation of both master cell banks and working cell banks may take up to three months – it is essential. These tests will highlight the presence of any adventitious biological contaminants, including viruses.

Cell-based assays are used to test for any viral contaminants. Usually, multiple cell lines – maybe three or four – will be employed in the test runs, preferred because of their susceptibility to a range of viruses. One of these will be the cell line that is being used in the manufacturing process, such as the CHO cell line, and another will be www.expresspharmaonline.com

Viral inactivation and clearance While the testing of raw materials and cell lines provides important information about the presence of viral contamination, it does not guarantee there is none.

Fundamentally, it will only detect viruses that are actively tested for. Unknown viruses may still be present.

Therefore, for safety reasons, regulators have instituted specific requirements to incorporate steps capable of inactivation or removal of potential viral contamination, from those known to be present, to those that are currently unknown.

Generic platform-type processes are typically used to manufacture biopharmaceutical products like monoclonal antibodies. The purification processes are, therefore, similar, so it is relatively straightforward to incorporate viral

inactivation steps to prevent viral contamination of the final product. Regulators demand the inclusion of at least two robust techniques to ensure minimal amounts of the virus remain; these must operate via different mechanisms. The two most common techniques are incubation at low pH, which inactivates enveloped viruses, and nanofiltration, which is able to remove both enveloped and non-enveloped viruses.

It is usually fairly easy to include a low pH inactivation treatment in the purification process, especially if the first capture step of the purification is a Protein A-based affinity step. In this process, the pH of the buffer is reduced to elute the product, therefore giving an obvious point for the introduction of a low-pH inactivation step. To insure viral inactivation, the pH is adjusted to a defined range, usually between 3.5 and 3.9, and held there for one to four hours.

This technique is very effective at inactivating many enveloped viruses, particularly those with low, or low-tomedium, resistance to physicochemical influences. The efficiency of the ‘removal process’ is checked in the lab via samples spiked with model viruses, typically murine leukaemia retrovirus and pseudorabies herpesvirus.

There is a risk that the product may not be sufficiently stable for long periods at this pH, and thus its stability towards acid cleavage must also be checked to ensure it will not decompose on purification. If this is the case, alternative inactivation techniques must be investigated.

Solvent detergent treatAugust 16-31, 2013

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ment, which was developed in the blood products industry, can also inactivate viruses. It does this by interfering with the virus’s lipid coat, thus disrupting the viral membrane. The product is incubated in a defined concentration of solvent, which is typically 0.15 to 0.30 per cent TnBP, to accelerate the interaction between the lipid coat of the virus and the detergent.

This is usually Triton X-100 or Tween 80, and a typical concentration of detergent is 0.1 to 1 per cent. As with low-pH treatment, the technique is most effective on enveloped viruses.

Both of these methods work well for enveloped viruses, but rarely for non-enveloped viruses, as they are normally resistant to low pH and not affected by detergent treatment. A number of other techniques are also occasionally used to inactivate viruses. Gamma irradiation is frequently employed in the sterilisation of finished medical devices. UV irradiation is now starting to gain ground in the purification of monoclonal antibodies.

Beta-propiolactone treatment is routine for vaccine products, while formaldehyde treatment is also used in some cases.

Removing viruses The most robust – and most routinely used – method of virus removal, nanofiltration, relies on the relatively large size of the virus compared to the product. Filters designed to remove viruses from monoclonal antibodies and other protein products have pore sizes in the range of 15–20nm, and the smallest pore size that still allows the product to pass through successfully should be selected, as this will retain the maximum amount of virus.

Nanofiltration can be particularly effective for the removal of common viral contaminants that low pH treatment fails to inactivate, including minute virus of mice, which is often present in murine cell lines.

The starting point for a biomanufacturer will invariably be the brand of filter they already use within their platform process; all the major filter manufacturers produce nanopore filters for virus removal, including Asahi, Millipore, Pall and Sartorius. However, this may not be the best choice for an individual product, and test runs using different filters should be carried out to identify which gives optimal results while minimising the filter area required, for cost reasons. Regulators are looking for at least a 4-log reduction of model viruses in test runs.

During the process development Vmax studies are conducted to define the operational capacity for the filter.

This helps determine the defined membrane area required to process the production scale batch. Careful design of the spiking study is critical to ensure that this defined capacity can successfully be validated in the study. Of course, the virus spikes must be of sufficient quality to ensure they do not adversely impact the validation study.

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All filters are not the same, and this is even more the case in realworld process use. They are all able to remove viruses, but filter capacity and flow decay is different from filter to filter, process to process and product to product. As a result, the brand of filter a manufacturer is most familiar with may not be the one that gives the best results. This is why careful testing of more than one brand of filter is essential for each different product.

Alternative removal strategies While nanofiltration is by far the most robust technique for removing viruses, there are other, albeit less reliable, techniques. Perhaps the most important of these is chromatography, which is commonly included in the platform process’s purification steps.

Its lack of robustness results from the number of variable operational parameters that make it difficult to replicate conditions precisely from one run to the next. These include operating capacities, flow rates, buffer pH and conductivities. Even minute variations can have an impact. Proving that changes in these parameters had no negative impact on the effectiveness of viral clearance would be both challenging and expensive.

However, chromatography does have its place in the viral removal arsenal, as it can provide an additional ‘belt and braces’ level of confidence that a virus is being removed effectively. The precise nature of the viral clearance via chromatography varies.

Commonly, the virus binds to the column as the product flows through, and is then removed from the column before it is reused via a regeneration procedure. In other chromatographic processes, the difference in binding affinity for the column enables the virus and the product to be separated.

In some cases, particularly where a Protein A affinity step is being used, a combination of inactivation and removal by chromatographic separation is taking place. If this is the case, tests should be run to identify how much of the virus is being inactivated and how much removed. A PCR-based assay that detects the viral genome will be able to provide this information, since it does not discriminate between inactivated and infectious virus.

Improving safety It remains impossible to ensure that no viral contamination whatsoever enters a biomanufacturing process.

Some viruses are inherently present in the cells that are used in cell culture; others commonly occur in other starting materials. However, a comprehensive programme of efficient testing strategies and effective removal and inactivation processes will ensure the safety of biological products.

Regulatory guidelines have been established for a reason: mainly, patient safety; only by implementing them carefully and fully validating their effectiveness, can this be achieved. www.expresspharmaonline.com

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PRODUCT Encapsulation and spray drying solutions by BUCHI pray drying is the definitive one-step drying process to transform solutions, emulsions, slurries or melts into a dry powder. The liquid droplets are atomised by a specialised nozzle and sprayed into a hot dying gas to form the required particles.

The new and innovative Prilling by Vibration technology Encapsulator from BUCHI offers immobilisation of enzymes, drugs, flavours and fragrances, vitamins, oils, cells or microbes into a wide range of polymers. Uniform beads and capsules are produced. The bead diameter is pre-selectable in the range of 0.15 mm to 2 mm with a narrow standard deviation and a productivity of up to 6’000 beads per second.

S

The potential applications are: Powders for pulmonary diseases: Generate particle sizes with low density and as small as 5 µm for quick and easy delivery into the lung(s). ✵ Encapsulation of oils for easier handling, taste and flavor masking ✵ Controlled drug release for efficient use of medicine ✵ Easier handling and dosing of expensive products in a cheaper carrier BUCHI’s product line consists of the Mini Spray Dryer B-290, Nano Spray Dryer B-90, Encapsulator B-390 and Encapsluator B-395 Pro, which produces particles from nano and up to millimeter

size. Additional we also offer many accessories to help increase the number of applications.

The new accessory for our Spray Dryer line, the Dehumidifier B-296, enables the constant supply of inlet air with the same properties, allowing the constant obtainment of reproducible results. Furthermore, it is also possible

to work continuously with organic solvent(s) and water mixtures when the dehumidifier is used in combination with the Inert Loop B-295.

Contact details: Email Id: india@buchi.com Phone No: 91-22-66775400.

Website: www.buchi.in

Crystallisation tools for...

Continued from Pg 41 be supplied to allow sample volumes from 1ml upwards to be studied.

Parallel studies for higher throughput Some of the larger companies or even smaller ones that have lots of samples to evaluate need multiple crystalEYES units working in parallel. CrystalSCAN is exactly such a system, designed to handle 4 or 8 samples in parallel with sample sizes from around 1ml up to 100ml.

In order to permit a range of concentrations to be studied automatically (for each sample), it is necessary to dilute the samples after successive heat./cool cycles. The CrystalSCAN is unique in being able to achieves this by using one or more precision syringe

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pump with a multi-way rotary valve.

The type of data that is generated by crystalSCAN for each vial is shown in Figure 3, for potassium nitrate in water – this is very similar to Figure 2 in terms of the heat/cool cycles but with

dilutions after each cycle.

When the appropriate crystallisation and re-crystallisation points are collated, MSZW plot such as in Figure 2 is produced.

Quality of data

accuracy of the above measurements, the data can be compared to literature solubility results for potassium nitrate (Crystallization, JW Mullin, 2001). This is shown in the Figure 4. Good agreement is clearly observed.

In order to confirm the

Conclusion

IN ORDER TO PERMIT A RANGE OF CONCENTRATIONS TO BE STUDIED AUTOMATICALLY (FOR EACH SAMPLE), IT IS NECESSARY TO DILUTE THE SAMPLES AFTER SUCCESSIVE HEAT./COOL CYCLES. THE CRYSTALSCAN IS UNIQUE IN BEING ABLE TO ACHIEVES THIS BY USING ONE OR MORE PRECISION SYRINGE PUMP WITH A MULTI-WAY ROTARY VALVE www.expresspharmaonline.com

It is clear that crystallisation studies in parallel can be performed at sample sizes as low as 1ml or as large as several hundred millilitres. The data scales up reliably and thus provides an excellent early insight into the key variables. While CrystalSCAN appeals to situations where large numbers of samples need to be studied, CrystalEYES can generate exactly the same data on a single portable platform.

They use the same detection method which is both reliable and accurate.

August 16-31, 2013

PHARMA TECHNOLOGY REVIEW Pro‘tech’ting the brand Technology has been an important tool for pharmaceutical brand protection. Over the years many new technologies have been introduced to curb the menace of counterfeiters, though with mixed response. Sachin Jagdale reports on prospective technologies that may find takers in the future for pharma brand protection

SIDDHARTHA SENGUPTA Regional Sales Director, Asia (Decoratives), Merck he global pharma industry has so far remained the largest victim of counterfeiting.

Though pharma packaging industry has witnessed radical changes in the last few years by updating itself with innovative technologies, technology invaders/infiltrators have time and again proved themselves equal to the task. However, on the other hand, despite the loopholes, the fact should be accepted that use of advanced technology has indeed helped reduce the incidences of counterfeiting to considerable levels.

MURLI SUNDRANI Business Director, BD Medical-Pharmaceutical Systems Item Number (GTIN) are still in use.”

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Technology to the rescue As the losses due to counterfeiting run into billions, the importance of technology rises further. For many years an array of security techniques were employed to safeguard the pharma products with fluctuating success ratios. Techniques like Radio Frequency Identification (RFID) track and trace tagging, different types of holograms, customised varnishes came handy but still fell short of completely safeguarding the pharma products. Meantime, packaging technology solution providers continued with their efforts to invent superior solutions for the pharma players.

Siddhartha Sengupta, Regional Sales Director, Asia (Decoratives), Merck, explains, “Overt solutions from Merck use special pigments that change colour enabling the consumer to see visual effects without the use of any verification device and distinguish between real and August 16-31, 2013

Plugging the loopholes

Overt solutions from Merck use special pigments that change colour enabling the consumer to see visual effects without the use of any verification device and distinguish between real and fake products

Many new technology and packaging interventions are available now to ensure that any attempt to tamper or pilferage the drug product is identified and made visible on the packaging to give a clear indication to the user that it has been tampered with

fake products. Covert solutions are usually created for brand owners to identify their original product and are recognisable only through technical means. Brand owners could opt for overt solutions alone or even club them with covert solutions for complete brand protection. These solutions can be used for simple printing through processes like Gravure, Flexo or Screen as well as in overprint varnishing and mass colouration of plastics/containers.”

The technology introduced by Merck is exceptional as it enables the consumer to identify original products by unique and visible colour shifts, quite unlike the commonly used holograms which are complex, difficult to dif-

ferentiate and can be easily replicated. The pigments in the form of ink can be used even on existing design through simple modifications.

According to Shruti Bhat, Chief Operations Officer, Innoworks, Canada, understanding counterfeiters' capabilities, skills, opportunities, tools and financial gains is important before developing a technology to avoid any misplay with the pharma product. While citing overt and covert techniques as among the important means for brand protection, Bhat adds, “Track and trace techniques — digital tools like SMS, cloud based management systems, ePedigree, serialisation, RFID, 2D barcodes and Global Trade www.expresspharmaonline.com

There is a continuous evolution in the measures employed for pharma brand protection.

Each new technology comes with more advanced features. Though over the last decade technology for brand protection has witnessed a major facelift, counterfeiters still somehow manage to breach the security measures of the pharma product. Industry experts explain why.

Bhat highlights some of the important factors. She says, “Fakes can be made relatively cheap. Easy and cheap access to high quality graphic design technologies, combined with low cost scanners and imaging programmes provide the means to create realistic counterfeit package and labels.”

Speaking about the legal aspects, Bhat adds, “Many countries lack adequate regulations and/or law enforcement. Even in the industrialised countries, the risk of prosecution and penalties are inadequate.” She further explains, “Drug prices vary among countries across the world and parallel trade is widespread, allowing counterfeit medicines to enter the supply chain. High cost of drug development and rising demand for prescription and OTC drugs coupled with rising supply shortages is also an issue. Moreover, problem is not recognised as more than a commercial issue associated with branded Continued on Pg 50

W H AT ’ S INSIDE

‘We consider external experts’ engagement and clinical research as a major business area to grow’ PG 46 Facility design requirements for high potency APIs PG 48 Why drug manufacturers should choose PFIs over APIs? PG 50 Spray pattern and plume geometry analysis of a nasal powder product PG 51 Multisorb to exhibit StripPax and StabilOx Systems at PharmaPack India PG 52 Cole-Parmer launches 7th annual catalogue PG 53

MARKET 15 MANAGEMENT 33 RESEARCH 39 LAB NEXT SPECIAL 41 PHARMA LIFE 79 EXPRESS PHARMA

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‘We consider external experts’ engagement and clinical research as a major business area to grow’ Six-year-old D2L Pharma Research Solutions, engaged in drug development process, had started its business with an aim to explore business opportunities in clinical research and pharma business intelligence segment. Within a short span of time, the company has established its client base in the US, the UK and Europe. Dr K Sashi Kiran, Co-Founder and Managing Director, D2L Pharma Research Solutions reveals its success and business agenda with Usha Sharma

INTERVIEW

D2L Pharma Research Solutions uses the term 'Discovery to Launch'. Tell us more about it.

We started with a vision to serve the value chain of drug development process from 'Discovery to Launch'. A journey that began in 2007 and we have been striding foward ever since. D2L was not an accidental venture; it was a venture of common interest and a defined focus. And three of us i.e. Dr Sashi Kiran, Cofounder and Managing Director, Deepak H, Cofounder and CEO, and Shekhar Gupta, Co-founder and COO, with complementary expertise and business interest came together to start D2L Pharma. Today it is a fast growing integrated service provider serving the needs of the global pharma industry.

D2L started its business operations with an aim to explore the opportunities that existed in the business of clinical research and pharma business intelligence.

We, like many modern Indian ventures, have leveraged the economic opportunities of an Indian start-up.

At D2L, we have expertise with professional background and hands on working experience in the management team, which is driving the organisation.

Our management team consists of experts from clinical research organisations (CRO), pharma companies and marketing areas and we consider this as an optimum complimentary formula of success for our business. We have our business operations in those markets which gives us better growth from the day of our company's inception.

Since 2007 till date, we have grown from a team of three people to 100+ people.

What are the services offered by the company?

We are a service-oriented

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company operating in five different business lines viz; clinical research, external experts engagement, market research and analytics, business intelligence and consulting and technology. Under each business lines, we offer a wide range of services.

Out of the five segments, which ones have the most potential and why?

We consider external experts’ engagement and clinical research as a major business area to grow because they have high potential for growth and have better future prospects for D2L. We feel that we are one of the very few companies in India who executes high quality external experts or KOL Research for global markets. Since the last five years we have been working in this domain with several clients from the US, Europe and the UK and this division has become a significant one in terms of revenue. D2L maintains over a million records of physician profiles and is also planning to come up with potential products in this area to cater to the global customers. D2L also works with several big key opinion leader (KOL) firms and medcom agencies of the Western world as a preferred outsourcing partner to leverage the advantages of cost, quality and timelines. Our clinical research is one of the fastest growing services in India. India, being one of the preferred destinations for clinical trials due to multiple reasons from cost, talent, patient pool, disease types, treatment naïve patients, good hospitals, etc, has a tremendous potential in the coming years.

Though there has been a dip owing to a variety of reasons, we are convinced that there is good potential. However, it should be noted that for clinical research to move on the fast track, the regulatory scewww.expresspharmaonline.com

nario has to be streamlined and uncertainty should be addressed. D2L expects the industry to pick up over the next few months. The regulatory scenario in the country is also now getting streamlined after a year long dull period and D2L, with a six-year plus service record, is gearing up to leverage the opportunities in the coming years. D2L also has a good pipeline of projects and serves as an exclusive partner of many pharma/ biotech companies in India.

Why is D2L Pharma’s services a preferred choice for pharma and biotech companies?

D2L works with several companies as a preferred outsourcing partner to leverage the advantages it offers like expertise, innovation in work, cost, quality and timelines. These are the key factors which makes D2L different, and is on the growth path irrespective of fierce competition.

Tell us about the services you offer in the clinical research arena?

We are one of the leading site management organisations in India and provide full support services to the pharma/herbal/ayurvedic/neutraceuticals/FMCG sectors in their product development through clinical studies and study of marketing claims. We also offer services in project management, staffing and recruitment services, site management and solutions, clinical site preparation, trial agreement assistance, site training and staffing, essential documents management, ethical submission coordination, patients recruitment coordination, patients follow-up and study compliance, data compilation and query resolutions, site inventory management and study monitoring as well as site close-out operations.

What parameters do you follow for complying with data safety?

Data safety is of prime importance in this industry.

We take all the mandatory and essential steps to comply with safety requirements like site preparation for regulatory audits, internal monitoring at

regular intervals to maintain quality data, frequent trainings of site personnel, implementation of site specific SOPs, prevent major findings during an audit, mandate audit follow up actions are implemented within the stipulated timelines, ensure that major findings, if any, are not repeated in future. High level of confidentiality is maintained for the clinical trial data generated, apart from restricted access to clinical trial information, mechanisms for controlled access to our premises, rooms containing clinical trial information are equipped with disaster management tools, server with data backup facilities, individual user name and passwords are also provided.

Exchange of study specific information between different teams is not encouraged.

Tell us about your domestic and international clients?

Till now we have worked with more than 75 clients in the last six years, with many of them where D2L have longterm service-level agreements (SLAs). The majority of our clients are from the US, the UK, Europe and many Indian clients for our clinical and market research divisions.

Can you share some of your clients’ success case stories?

We are successful only when our clients are happy and they also achieve the end results. There have been many such instances in the last six years. One of our clients acquired a company for $2 billion, based on the market forecast and opportunity analysis done by us. Similarly, one of the clients got a vaccine prequalified by WHO for global supplies. It always makes us happy when we see that our clients are able to bank on us for their success.

Do you think your services are cost effective and how?

Yes, our services are cost effective when we compare with the cost of such services in the Western world. We are also cost effective than many of our global competitors.

How many players are there in this sphere presently?

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cal research services though we are one of the leaders in site management services. There are many companies in the market offering similar services.

However, we feel that since the clinical research industry is becoming more and more stringent and streamlined, the smaller companies will fade out and companies with experience and capabilities which follow "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) guidelines and Drug Controller General of India (DCGI) regulations in India will endure. In the other business lines, there are very few companies (four to five) in India who provide such offshoring services. D2L is a very niche player in these segments.

What is your opinion on the role played by market research and analytics in the pharma industry?

In today’s fast changing competitive world, pharma companies have realised the importance of understanding consumer insights, the prescribers’ perception to their brands, sales of their own and competitors’ products, sales and marketing, forecasting, marketing mix, etc. This is where market research along with high-end analytics play a huge role. The big-data and analytics opportunity is exciting in complex business settings, experiencing an explosion in the types and volumes of available data.

Which are the complex and important areas when it comes to market research analysis?

Data driven analysis provides meaningful insights but the challenge here is to obtain consistent and reliable data. Once the data is available, the next level of challenge is to manage and integrate them seamlessly across the value chain (from discovery to real world use after regulatory approval) so as to enable companies to leverage the same for their business needs. In our view, end-to-end data integration - be it internal or external, proprietary or publicly available data – is crucial. Typically, companies deploy a two-step approach - first, they prioritise the specific data types to address (usually clinical data) and secondly create additional data warehousing capabilities as needed. The strategy is to first analyse the most important data and leverage it for business decisions within a short time span. In many cases this process could take a year and calls for significant infrastructure and procedural changes.

Post this stage, firms develop an approach for the next level and prioritise data including scenario analysis, ownership, as well as expected costs and timelines.

How many projects have been accomplished so far and for which therapeutic areas?

In the clinical research segment, August 16-31, 2013

we have finished more than 50 trials in India across various therapeutic areas. The market research and analytics division has conducted multiple market research surveys across all specialities, targeting all kinds of healthcare professionals or patients, requisite for an identified objective. We have conducted over 75 different kinds of market research projects across different therapeutic areas using several platforms including webbased applications. D2L has a panel of over 20,000 physicians in India who are easily accessible for all our studies.

One of our strongest areas is external experts engagement services. D2L has successfully completed over 115 global KOL projects and over 25 global nominator surveys. We have researched and ranked more than 50,000 experts across several therapeutic areas and disease states.

How many projects do you have in the pipeline?

We have quite a good number of projects lined up in the clinical research for this and the next financial year. For other segments it is more of long-term service level agreements (SLAs) with full time engagement (FTE) models and hourly models. It is difficult to define the pipelines as usually they come quickly and have to be delivered very quickly as well.

Overall, we see very good business lined up this year and we expect to meet our revenue targets.

How many people are associated with the company and how skilled are they?

We recently shifted to a new stateof-the-art facility near ITPB Whitefield which can accommodate 150+ people. Our people are from diverse backgrounds like life sciences, clinical research, biotech engineering, management, pharmacy, statistical, medical, and IT. Our people are experienced in handling global clients in terms of understanding their needs to execution and delivery of the projects.

The company imparts regular training to all employees in various areas to enhance their project management and soft skills.

What are your corporate plans?

At this point our plans are very simple but at the same time very aggressive to expand our external experts engagement, market research and analytics, business intelligence and consulting services to the US and the UK markets. We have plans to launch few product lines in this space to add new growth avenues. We are constantly evaluating new service lines and products. As said earlier, the clinical research industry grew slowly during the last one year, however, it is now reviving and we hope that the business will pick up soon. The company aims to touch the $10 million mark by 2016. u.sharma@expressindia.com www.expresspharmaonline.com

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INSIGHT Facility design requirements for high potency APIs Amrit Karmarkar, a Mumbai-based pharmaceutical and clinical consultant, gives an overview on HPAPIs current market, machinery requirements, facility design aspects and handling issues ighly active chemical substances or drugs are one of the fastest growing segment of pharmaceutical industry. Different Indian multinationals such as Cipla, Dr Reddy’s Laboratories, Ranbaxy, Sun Pharma have set up their high potency active pharma ingredients (HPAPI) facilities across India. Handling, containment, manufacturing, facility design, machinery and regulatory requirements of these compounds are more stringent and different from conventional APIs. This review focuses on current market, machinery requirements, facility design aspects and handling issues.

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Introduction There is great demand for HPAPIs since the last 17 years. Advancements in clinical pharmacology and oncology, AIDS research has resulted in emergence of HPAPIs in market. Large numbers of HPAPIs are currently undergoing clinical trials and will soon reach commercialisation. Due to the potent nature of HPAPIs, there must be a keen eye on the evaluation of these compounds for toxicity. Also for manufacturing pharma products, safety and containment issues must be monitored. European Medicines Agency (EMEA) has taken the initiative so far to issue a concept paper regarding this type of drugs.

Indian scenario The pharma industry is one of the booming industries in India. Current annual growth rate (CAGR) for this industry is 12-14 per cent according to McKinsey Report. The industry has seen a growth up from $1 billion in 1990 to $20-24 billion by 2015. Active pharma ingredients (API) manufacturing is the key business in India’s pharma sector. Nonetheless, India has around 75 US FDA approved manufacturing plants. HPAPIs are relatively the new segment in Indian pharma sector but due to demand of cytotoxic/anticancer drugs in India, the companies are setting up their plants in India.

Carbogen Amcis, a Dishman Group company has set up 4300 sq m site at Ahmedabad in 2010 at the cost of $20 million which is in compliant with current good manufacturing practices (cGMP). This is an initial step by foreign companies to invest in India’s HPAPI market. Soon more companies will plan to set up their activities in India.

Even, Indian multinationals like Cipla, Lupin, Dr Reddy’s Laboratories have set up their oncology drugs facilities in the country.

Overview of the global market Global HPAPIs market is expected to grow at a CAGR

MANUFACTURING HPAPI IS A COMPLEX PROCESS INVOLVING MANUFACTURING AND PROCESSING IN CLEAN ROOM OPERATIONS WITH CONTAINMENT FACILITIES.THESE PROCESSES ARE CARRIED OUT AT NEGATIVE PRESSURE TO PREVENT MATERIALS FROM ENTERING THE ENVIRONMENT 48

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of 8.4 per cent till 2015.

Cytotoxic agents (oncology segment) market out of them is itself growing at a CAGR of 12.6 per cent globally. North America predominates the HPAPIs market in the world with a 45 per cent share. The US has a dominant share of 93 per cent out of them. A majority of the drugs in this region are from anticancer, hormonal, glaucoma, etc.

Major players in the North American market are Teva, SAFC, Carbogen Amcis, Bristol Meyers Squibb, Asymchem, etc. Europe is second largest market with 35 per cent share in HPAPIs industry.

Bristol Meyers Squibb, Lonza, Bayer, Boehringer Ingleheim, Sanofi Aventis, Carbogen Amcis are some of the companies leading the HPAPI market in Europe.

However, in Australia, IDT is a leading player for HPAPI. In the Asian scenario, Japan, China and India are the most emerging markets. In total, it is estimated that more than 25 per cent of the drugs in clinical development pipeline are in this category.

HPAPI facility design As HPAPIs can get access to body systems via inhalation, accidental injection, ingestion of contaminated foodstuffs or mouth contact with contaminated hands and dermal absorption; protection of personnel is the first criteria in facility design.

Manufacturing HPAPI is a complex process, and involves manufacturing and processing in clean room operations with containment facilities. These processes are carried out at negative pressure to prevent materials from entering the environment, with workers wearing full protective gear.

It is advisable that containment equipment must be available throughout the process of HPAPI from bulk

API production to product formulation.

Containment device selection, setting targets, and verifying containment performance by factory acceptance test (FAT) and site acceptance test (SAT) are the key steps in achieving HPAPI production and processes. Use of airlocks, barrier isolators, transfer chambers, bagging devices, rapid transfer port, buck valves, split butterfly valves is helpful. For change room areas, systems such as mist shower or air shower are also used.

Following are three ways by which HPAPI facility and processes can be set up:

Full containment technology In this design method, sampling of active and transfer can be done by disposable, low cost charging bag. Excipients can be dispensed using dispensing isolator. Containment sifter with compact airlock sieve allows sifting of ingredients of formulation. Pot processor or integrated granulation system can be used and blending can be carried out in-line with granulation to avoid exposure.

Containment tablet press with 'wash in place' facility or wash offline mode with exchangeable compression module technology (GEA) can be used. Auto-coater with discharge using split butterfly valve and clean in August 16-31, 2013

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Packaging can be done with isolator operation.

Containment using isolators Here isolators are used for creating controlled environment for manufacturing activities. Sampling of actives is done in isolators and excipients are dispensed using dispensing isolators with split butterfly valves. For material handling across all the process intermediate bulk containers (IBC) with containment valves can be used.

All granulation and compression machines will be stored inside isolator for manufacturing activities.

Closed transfer of tablets will be done to coating area wherein coating machine is also fitted inside isolator. Barrier systems can also be used for packaging.

Combination of first two methods (cost effective) This might be a cost effective approach for manufacturing HPAPIs. Here sampling is done in the isolator and double bagging can be used while material transfer.

Sifter can be installed within isolator or the containment sifter can be used directly. Granulation and blending can be done in single pot processor. Wash in place and wash offline tablet press can be used for manufacturing tablets and using closed transfer system they can be transferred to coating area wherein auto-coater or coater in isolator will be installed. Packaging can be done in isolator.

For all processes, document transfer enclosure must be there to allow paperwork in processing to be handled in contained way so that powders are not transferred onto documents. This prevents contamination to individuals that are not protected. This system has a set of glove sleeves, bag in bag out canister, space to store plastic bags, and stainless steel frame. Document transfer enclosures of Dover Pac are popular in industry.

Important considerations for HPAPI facility a.Personnel considerations Basic requirements of manufacturing activity is use of standard operating procedures (SOPs), regular review of materials safety data sheet (MSDS), and use of personal protective equipment (PPEs). Gloves appropriate for the chemical being handled and double gloves must be used for handling HPAPIs. American Society for Testing and Materials (ASTM) designates chemotherapy gloves capable of resistance of permeation by chemotherapy should be preferably used. Gowns or coveralls must be used. These should have properties like lint free, low permeable, closed front, long sleeves, and elastic/knit closed cuffs. Cuffs of these gowns August 16-31, 2013

must be tucked under gloves.

Safety glasses and N95 HEPA masks must be used. Powered air purifying respirators (PAPR) are the choice in the manufacturing or processing of HPAPIs. PAPRs are battery operated, consists of a half or full face piece, breathing tube, battery-operated blower, and particulate filters (HEPA only). b.Protective goggles Protective goggles help in preventing exposure of HPAPIs to eyes.

These goggles are flexible and are made of scratch proof material with anti fog coated lens. Key feature of these is they can also fit on your spectacles. c.Waste disposal facilities Sufficiently large and leak proof waste disposal containers with specially made plastic bags of high density must be available in every area of manufacturing plant including store. All HPAPI waste must be stored into these containers or bags. d. Emergency washing Whenever exposure of highly potent compound happens to any person in the working area especially when eyes and skin are exposed, it may cause irritation, skin burn or any other potential hazard may occur. To prevent this, emergency washing facility must be used. These can be plumbed or portable washing units that can use isotonic saline flushing solution for washing. e. Use of air and mist showers These are only one-way rooms.

Air showers installed at entrance of cleanroom help in minimisation of particulate matter entering into cleanroom area. HEPA jets can be used and contaminated air is drawn through bottom of unit, filtered and recirculated. Room for collection of protective clothing is necessary near air shower. In mist shower, highly pressurised water is spread on protective suit of person to drain the powder material in cleanroom area. This prevents passing out of hazardous material (HPAPIs) from circulating in air while de-gowning process. Mist showers are more advisable in industrial processing than air showers.

Conclusion Due to demand in the market many companies are planning to set up their HPAPI facilities across different countries of world. Facility design of HPAPIs is always challenging as it includes many issues related to containment in every process. High use of containment guarantees safety to personnel working in the clean room area.

Proper facility design with use of SOPs, training of operators, containment equipments, process isolation, facility design, personal protective equipment, and cGMP activities will help to prevent potential hazard during HPAPI production. www.expresspharmaonline.com

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Why drug manufacturers should choose PFIs over APIs? Vijay Ramanavarapu, Head – Supply Chain & Procurement, Granules India elaborates about the reasons on why drug manufacturers should consider buying PFIs instead of making it themselves

aking Pharmaceutical Fo r m u l a t i o n Intermediates (PFIs) involves taking Active Pharmaceutical Ingredients (APIs) and adding excipients to make a proper blend for the finished dosage. So an in-house PFI manufacturer has to contend with the high testing costs, complex supply chains to buy excipients and also allocate technological resources to develop the PFI. Finished dosage manufacturers usually purchase APIs from suppliers and manufacture PFIs in-house in order to prepare the material for finished dosage manufacturing.

However, since most of the manufacturers only produce low volumes, they create PFIs on a small-scale basis, which increases their testing costs.

Manufacturers can also increase capacity utilisation by running a continuous cam-

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Pro'tech'ting the...

Continued from Pg 45 products.”

According to Sengupta, pharma is probably the easiest to counterfeit since there are cheap substitute drugs that are available in India. While highlighting non-technical factors, he says, “The government authority is not stringent.

Counterfeiters can easily enter into the market, make profits and exit without being noticed.”

Prevention is the key Wherever possible, product manufacturers themselves try to use technology in such a way that it would leave a very minimal chance for tampering with their products.

By using high-end technology

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some of the drug delivery systems have been made almost resistant to counterfeiting. Murli Sundrani, Business Director, BD Medical Pharmaceutical Systems, elaborates, “Pre-filled syringes are a great example of how the injection process has been made convenient and safe.”

He adds, “Many new technology and packaging interventions are available now to ensure that any attempt to tamper or pilferage the drug product is identified and made visible on the packaging to give a clear indication to the user that it has been tampered with. Every detail including labels/stickers to small seals and tamper-evident mechanisms are being used in the industry. These are quite sim-

paign of select products instead of making small batches of multiple products.

Running a long campaign will reduce downtime since it will minimise cleaning between product changeovers.

In addition, finished dosage manufacturers need to have a complex supply chain as they need several excipients. All this entails additional costs since the manufacturer would need to audit their suppliers and also keep a ready inventory of material in the warehouse.

small-scale equipment to suit their immediate needs. This increases the cost since they need to test for each batch and also reduces flexibility in case the demand increases.

By purchasing PFIs from a specialised manufacturer, customers can reduce their costs and increase their return on investment since they do not need to invest in machinery, technical knowhow and personnel.

Buying PFIs is a good business strategy

PFIs can be designed to replicate the release properties of a brand leader’s finished dosage. So it will be easier for the drug manufacturer to pass the bio-availability studies. A drug manufacturer may not have the know-how to granulate APIs correctly to ensure this.

Focus on producing tablets instead of trying to create the proper granulation blend. PFIs require their own unique manufacturing equipment. PFI machinery is expensive and complex, which is why it is not economically feasible for every drug manufacturer to make their own PFIs. Due to the complexity of the machinery, PFIs contribute to 80 per cent of the total cost of manufacturing of a finished dosage.

In addition, there are many different processes and equipment which a manufacturer can choose such as opting for a fluid bed dryer or a rapid shear mix. The manufacturer should know about the nuances of the machine and understand which technology is ideal for a particular finished dosage. Also, most drug manufacturers tend to buy ple but very effective tools”

Technology for all There are various technologies available globally for brand protection. However, a single company cannot be in a possession of all the technologies. As per experts globally, pharma players can share their technological expertise to safeguard their products. As brand protection is a global concern it would benefit all the stakeholders.

“The process has already begun,” informs Bhat. Besides sharing their expertise, global pharma players have come together to take the legal route to curb the menace of counterfeiting. “In March 2013, pharma companies entered into an agreement with Interpol to boost the law enforcement community's response to pharma crimes,” reveals Bhat.

While stressing that there is www.expresspharmaonline.com

Lower regulatory costs – ensure regulatory compliance

Simplify the supply chain In addition, drug manufacturers need to have a complex supply chain since they require several excipients. In addition, PFIs have a more stable shelf-life which provides flexibility for customers since they can store material, if necessary. PFIs resolve many of the shortfalls of APIs and are less prone to temperature variations.

Make the manufacturing process more efficient Manufacturers are able to no 'one size fits all' or a single magic bullet to safeguard the pharma product, Bhat talks about future technological possibilities that could be implemented for brand protection. She says, “Added layers of security features to products, and facilitate detection and identification of counterfeits through digital and analytical lab methodologies will find takers in the future.

Techniques using Raman spectroscopy and energy-dispersive X-ray diffraction (EDXRD) can be utilised to discover counterfeit drugs while still inside their packaging. Sophistication in chipbased RFID and non clonable ID technology (nCiD) will also play a major role.

Solutions like Signature DNA technologies involve a platform consisting of custom DNA sequences, which are then embedded into a variety

granulate in-house, but they might not be able to garner efficiencies if they’re trying to master dozens of products or if they only produce the product for a few days at a time. It takes time and experience to understand the unique characteristics of an API in order to manufacture a PFI that meets the required flow and compressibility characteristics. Most companies have focused R&D efforts on API or finished dosage production.

Companies that do not actively research PFI production will not be able to garner the efficiencies that are required to create a cost-competitive product.

Some of our customers also approached us after facing operational problems in the consistent manufacture of PFIs. The result was that they were unable to get the desired properties of the PFI. of host carriers such as ink.

The ink is then printed on to the packaging using Flexo, Offset, Gravure or thermal transfer printing.”

According to Sengupta, Liquid Crystals (LC) will be the future in printing. This technology is already being used in currency notes.

Invisible inks and hidden texts are other possibilities.

Technology is the backbone of any industry.

Pharma industry deals with life and death of the consumers, so maintaining brand integrity has always remained a challenge for it.

As the incidences of counterfeiting are still a common occurence, in future the major challenge would be to innovate a foolproof measure that will plug the loopholes found in currently available technologies. sachin.jagdale@expressindia.com August 16-31, 2013

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ANALYSIS Spray pattern and plume geometry analysis of a nasal powder product Intira Coowanitwong, Samiran De, Cara Breeden, and Julie Suman, in this study, evaluate the traditional approach used for aqueous nasal spray formulation in developing spray pattern and plume geometry methods for nasal powder formulation asal powder formulation filled in unit dose devices can be a feasible route of intranasal administration for biologics1, vaccines2,3, and other active ingredients4. Spray pattern and plume geometry are FDA recommended in vitro tests used to characterise pump performance4 and may provide valuable information related to bioavailibility5.

These tests are performed from the analysis of a twodimensional image of the emitted plume using a nonimpaction laser sheet-based instrument and an automated actuation station. Different devices are currently available to deliver nasal powder formulation3,4,6.

A study was performed to evaluate the in vitro performance of Aptar’s Unit-Dose Powder (UDP) pump at three different fill weights (5 mg, 10 mg, and 20 mg) of a nasal powder product containing a peptide, along with an absorption enhancer and bulking agent. In vitro spray pump performance was based upon spray pattern and plume geometry analysis as measured by a laser sheet based analysis instrument, SprayVIEW NSP (Proveris Scientific, US). Units were actuated using a SprayVIEW Automated Actuation System.

Using actuation parameters and software parameters developed at Next Breath, twenty units were actuated in the SprayVIEW NSP. Ten units were tested for spray pattern and ten units were tested for plume geometry.

Spray pattern is characterised by the Dmax (longest diameter), Dmin (shortest diameter), and Ovality Ratio (Dmax/Dmin). The starting camera positions and

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August 16-31, 2013

software parameters were routine parameters developed for aqueous nasal spray formulation. Different frame rates, camera positions, and spray durations (start and stop time) were evaluated during method development.

The frame rate was varied in order to select the optimal method with minimal background noise. The repeatability of the method was evaluated based on the variation (%CV) between actuations and between units within the conditions tested and visual assessments of the spray patterns.

Plume geometry is characterised by the spray angle and plume width. Spray angle is the angle of the emitted plume measured from the vertex of the spray cone and spray nozzle.

Plume width is the width of the plume at a given distance (e.g. 3 cm) from the spray nozzle. The starting camera positions and software parameters were routine parameters developed for aqueous nasal spray formulation. The stable phase

for plume geometry analysis

by SprayVIEW was selected from the plateau region of the intensity peak from the intensity graph. In general, the frame where the spray was most intense was selected.

Different frame rates and camera positions were considered during method development. In addition, a qualitative assessment of the time delay (frame selection) and intensity for spray angle measurements was evaluated for plume geometry.

Results Representative images of spray pattern and plume geometry at different fill weights are shown in Figures 1 and 2, respectively. Spray pattern was measured at a 3 cm nasal tip-to-laser distance with a frame rate of 500 Hz. The spray duration was manually selected for spray patterns analysis. Plume geometry was measured at a 3 cm plume width distance from the nasal spray tip with a frame rate of 250 Hz. The time delay (i.e., frame selection) was manually chosen

Julie Suman from the plateau region on a case-by-case basis. Ovality ratio of typical aqueous nasal spray has a typical range of 1.1 to 1.2; images appear more circular and symmetric.

The ovality ratios were higher i.e., 1.6 to 1.9. The images were also more intense than seen with nasal liquid formulations and more elliptical in nature.

Refer to Tables 1 and 2 below for the in vitro pump performance of the nasal powder product. Pump delivery was assessed during

Figure 1. Spray patterns at 3 cm distance from the device tip at different fill weights of nasal powder product containing a peptide in Aptar’s UDP device

Figure 2. Plume geometries at 3 cm distance from the device tip at different fill weights of nasal powder product containing a peptide in Aptar’s UDP device www.expresspharmaonline.com

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developed for analyses of a nasal powder product containing peptide, along with an absorption enhancer and bulking agent supplied in an Aptar’s UDP device. Traditional methods used for aqueous nasal spray formulations can be utilised to develop methods for nasal powder formulations. In vitro performance of the UDP device was similar at different fill weights, i.e., 5 mg, 10 mg, and 20 mg.

References Table 1.Spray pattern analysis of a nasal powder product containing a peptide

Table 2.Plume geometry analysis of a nasal powder product containing a peptide the studies. From the spray pattern study, the pump deliveries averaged to 4.5 mg, 9.7 mg, and 18.8 mg for the 5 mg, 10 mg, and 20 mg fill units, respectively.

From the plume geometry study, the pump deliveries averaged to 4.7 mg, 10.0 mg, and 18.9 mg for the 5 mg, 10 mg, and 20 mg fill units, respectively. All spray

weights were within ±10 per cent of the target fill weight.

Conclusion Spray pattern and plume geometry methods were

1. Lochhead, J.J. et al. (2011), “Intranasal delivery of biologics to the central nervous system,” Adv Drug Deliv Rev, Available at: http://www.sciencedirect.com/science/article/pii/S0169409X11002791.

2. Wang, S.H. et al. (2012), “Stable dry powder formulation for nasal delivery of anthrax vaccine,” J Pharm Sci, 101(1), pp.

31-47.

3. Marx, D. et al. (2011), “Do we need new devices for intranasal vaccination?”

Drug Dev & Del, 11(3), pp. 54-59.

4. Djupesland, P.G. et al. (2010), “Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migrane: a randomized, placebo-controlled study,” Cephalalgia, 30(8), pp. 933-42.

5. FDA Guidance for Industry (2002), Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing and Controls Documentation.

6. Pringels, E. et al. (2006), “Influence of deposition and spray pattern of nasal powders on insulin bioavailability,” Int J Pharm, 310, pp. 1-7.

7. Kublik, H. et al. (1998), “Nasal delivery systems and their affect on deposition and absorption,” Adv Drug Deliv Rev, 29, pp.

157-77.

VENDOR NEWS Multisorb to exhibit StripPax and StabilOx Systems at PharmaPack India Multisorb will be demonstrating its APA2000 StripPax Dispenser with an optional bottling line interface

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ultisorb Technologies will exhibit its calculations through operations programme and its StripPax and StabilOx Systems at PharmaPack. PharmaPack is an exhibition on pharma packaging which will be held in Mumbai from September 12-14, 2013. Multisorb’s calculations through operations programme has helped pharma manufacturers stabilise their pharma formulations.

Through expert consultation, Multisorb’s technical staff will provide an optimised sorbent (desiccant, oxygen absorber, etc) designed specifically for the product and its packaging. If canister or packet sorbents are the required format, Multisorb’s engineers will assist in selecting the related sorbent dispenser with

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the appropriate options for packaging line.

Multisorb’s leading systems are the StripPax and StabilOx Systems. The systems combine the StabilOx oxygen absorbing packets or canisters or StripPax sorbent packets with their respective corresponding dispenser, providing unparalleled insertion efficiency that is not achievable with unrelated sorbents and dispensers.

Pharma manufacturers have come to rely on StripPax packets for moisture sensitive products. StripPax packets are compact sorbents with a high moisture adsorption capacity.

The packets are offered in a variety of sorbent blends and sizes to meet specific packaging needs. As part of the StripPax system, StripPax www.expresspharmaonline.com

packets are designed to be inserted into your packaging using a StripPax dispenser.

Odour free and non-toxic StabilOx packets and canister resolve product instability issues related to oxygen degradation. StabilOx packets and canisters effectively reduce package headspace oxygen levels while managing headspace moisture and drug product free moisture to reduce or eliminate oxidative degradation. Both StabilOx packets and canisters are uniquely designed to be run on their respective StabilOx dispensers as part of the StabilOx system.

As part of the StripPax system, Multisorb will be demonstrating its APA-2000 StripPax Dispenser with an optional bottling line interface. The APA-2000 high-speed auto-

mated dispenser is capable of dispensing rates of up to 300 packets per minute. The dispensers are compatible with an array of packaging line configurations, including horizontal flow wrappers, VFFS bottling lines, thermoformed pouching, and other layouts.

Constructed with the highest quality sensors, drive mechanisms, and cutters, the APA-2000 offers exceptional durability and provides the highest level of performance.

APA dispenser will provide uninterrupted dispensing when an optional splicing station cabinet is used - the operator never has to stop the line to refill the sorbent packets.

All of these capabilities add up to higher efficiencies for your packaging operations.

EP News Bureau-Mumbai August 16-31, 2013

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Cole-Parmer launches 7th annual catalogue The catalogue will be a complete resource for laboratories and process facilities ole-Parmer has released its 7th annual catalogue for the scientific and process industries.

The new 2013/14 catalogue offers a full selection of products and services to enhance efficiency and produce best practices. The 300+ page catalogue has numerous unique and new products, as well as returning favourites.

Users can select from highly efficient laboratory essentials, lab equipment, fluid handling, and process equipment and find exactly what they need for their application—from research and development to pilot plants to scale-up. The catalogue also has convenient dual pricing featuring custom duty exempt prices and prices in rupees, making it handy for users to set up supply contracts.

At the catalogue launch, Rakesh Aggarwal, Director, Cole-Parmer India, said, “The new 2013/14 catalog underscores the company’s

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reputation of bringing the latest, hard-to-find products to customers. It is designed in such a way that products are positioned based on features and areas of application. Sufficient information is available in the catalogue—both technical and commercial—to make buying and using products much easier. The dual pricing provided also helps the user make a buying decision quicker. All of this makes our catalogue a complete resource for users.”

The catalogue includes a wide portfolio of products to address customers’ demanding manufacturing and process applications needs. Featured products in the catalogue include the Masterflex I/P Digital Process Drive, Oakton pH 700 Benchtop Meter, Rotational Viscometer, IKA EUROSTAR 100 Control Digital Mixer, Centrifan PE Small-Volume Evaporators, Cole-Parmer Polystat Cooling/Heating Circulating Baths, Masterflex L/S Precision Modular Drives, Shuttle Portable Ultra-Low

Temperature Freezer, and IKA RET Control Stirring Hot

Plate, to name a few.

EP News Bureau-Mumbai

Indegene builds on Aptilon acquisition, launches iMCM framework for pharma sector iMCM will help clients deploy enterprise-ready consistent, multi-message MCM programmes across brands efficiently and cost-effectively ndegene's Information Business Technology Services (iBTS) business unit has launched a robust and innovative Integrated Multichannel Marketing (iMCM) framework for pharma organisations.

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IMCM WILL HELP CLIENTS DEPLOY ENTERPRISE-READY CONSISTENT, MULTI-MESSAGE MCM PROGRAMMES ACROSS BRANDS EFFICIENTLY AND COST-EFFECTIVELY. IMCM HAS THE ADDITIONAL ADVANTAGES OF BEING AN OUT-OF-THE-BOX, MULTI-PLATFORM AND MOBILE-READY PLATFORM August 16-31, 2013

iMCM will help clients deploy enterprise-ready consistent, multi-message MCM programmes across brands efficiently and cost-effectively. iMCM has the additional advantages of being an out-of-the-box, multiplatform and mobile-ready platform.

Dr Rajesh Nair, President – Indegene said, “After the acquisition and integration of Aptilon in November 2012, we have accelerated our investments in the multi-channel technology R&D, and iMCM is the first of a suite of new solutions we will be launching in the market place.”

Sales and marketing departments at global pharma organisations are under www.expresspharmaonline.com

increased pressures arising from shrinking pipeline, patent cliffs, increasing compliance requirements from regulatory bodies, dwindling med-rep effectiveness, and surge of digital channels to engage physicians. Companies have started to look to IT to help exploit inherent opportunities as well as mitigate new risks arising from these market shifts. This has also put unconventional pressures on CIO offices to meet these changing business needs and to deploy enterprisewide solutions that enable new commercial models. iMCM framework provides CIOs with an enterprise-wide architecture that services all pharma stakeholders effectively.

The framework puts HCPs at the centre of focus and increases the effectiveness of

engagement through optimisations, resulting from the integration of applications within the technology stack.

The framework effectively combines Customer Relationship Management (CRM), analytics, multiplatform connectivity, multichannel/multi-device/multicontent interfaces, digital asset management, message publishing systems, and external systems including social collaboration platforms, and blog systems in an open and expandable architecture.

Nair added, “This novel approach allows clients to deploy stable and customisable MCM architecture across the enterprise effectively while providing the necessary flexibility that is critical to effective MCM deployment.”

EP News Bureau-Mumbai EXPRESS PHARMA

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SMBs: Rising above the challenges The three winners of Microsoft's Completely Boss Challenge competition will get a chance to build a five-year growth plan, with support from various industry experts KTP Radhika he challenges in the world of small and medium businesses are much different from those of large organisations.

Many small and medium businesses (SMBs) even find it difficult to understand their business strengths and weaknesses. As it happens, much of the valuable time of the CEO or owner of an SMB is spent on managing the workplace, attending phone calls, administration related work, fixing IT problems and many more mundane activities. Time that could have been—and should have been—better spent on taking critical decisions, planning for future growth, and other important tasks fit for a “boss.”

While most SMB leaders find themselves entangled in the routine operational activities, the three winners of Microsoft's Completely Boss Challenge presented a different story.

The winners belonged to Sort India Enviro Solutions (a recycling and waste management company based out of Vadodara), Hyderabad-based Rohini Minerals (a manufacturer of cost-effective poultry and cattle feed) and Mumbaibased Neptunus Power Plant Services (a solution provider for engine-based industrial and marine power plants).

And as a reward, they are all going to get support from Microsoft (on technology), LinkedIn (on talent), Moneycontrol.com (on media), WebChutney (on marketing), DOOR (on business consulting) and

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Paresh Tulsidas Parekh, Founder, Sort India Enviro Solutions

Gaddam Ranjith Reddy, Managing Director, Rohini Minerals

Uday Purohit, Managing Director, Neptunus Power Plant Services

CRISIL SME Ratings (on knowledge) to develop a five-year robust business growth plan.

Organised by Microsoft Office 365, The Completely Boss Challenge was India's first platform to reward and celebrate outstanding business leaders from India’s thriving small and mid-market sector.

Around 2500 CEOs from across seven cities (Delhi-NCR, Bengaluru, Ahmedabad, Pune, Chennai, Hyderabad, and Mumbai) contested in first three rounds of the competition.

The contest started with registered participants being evaluated on a quiz on knowledge and applicationbased questions, which was assigned weightage

by QuizWorks, a leading quizzing company.

Phase 2, which was city prelims, included events in the seven cities. The top 50 finalists from each city participated in the next level: an on-ground contest. Three short-listed candidates from

each of these seven cities participated in the finals of The Completely Boss Challenge; finally, three allIndia winners were selected.

Prashant Gubba, owner of Gubba Cold Storage based out of Hyderabad and one of the finalists of the competition, said that it was exciting to participate in the event and it gave his company a platform to present its business. Echoing the same sentiment, another participant, Vishwas Kulkarni, Director at Computer Home based out of Pune, felt that The Completely Boss Challenge is a perfect platform for his company to showcase its products and services and will help SMBs to attain greater heights.

the top three winners in a competition like this, which is a first-of-its-kind.

Uday Purohit, Managing Director, Neptunus, opined that Microsoft’s Completely Boss Challenge, targeted at the mid-market segment, is a great platform for SMBs to showcase their unique business models. “The competition opens up a whole new dimension for our business,” he said.

Ramkumar Pichai, GM Microsoft Office Division, Microsoft Corporation India, said that the experience of interacting with the midmarket CEOs has been very exciting and fulfilling. "This clearly shows that the Indian market has tremendous potential and it is further validated by the capability of the entrepreneurs who have come for The Completely Boss Challenge.

Unique business models, especially that of the winners, showcase immense potential to innovate and grow using technology to achieve competitive strength and business growth. These companies have developed a systematic innovation capability which assures them of a series of successes that deliver business value,” he said.

He also felt that programmes like The Completely Boss Challenge will enable SMBs to create, foster and grow innovative business models that have a positive impact on their communities and at the same time are crucial to India’s economic growth.

MICROSOFT’S COMPLETELY BOSS CHALLENGE WAS INDIA'S FIRST PLATFORM TO REWARD AND CELEBRATE OUTSTANDING BUSINESS LEADERS FROM INDIA’S THRIVING SMALL AND MID-MARKET SECTOR. THE MAIN CRITERIA FOR CHOOSING THE WINNERS WERE THEIR BUSINESS STRENGTH, COMPETITIVE ADVANTAGE, HOW BETTER THEY MANAGE IT AND THE FINANCIAL GROWTH OF THE COMPANY 54

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www.expresspharmaonline.com

A platform to grow The main criteria for choosing the winners were their business strength, competitive advantage, how better they manage it and the financial growth of the company. Paresh Tulsidas Parekh, Founder, Sort India Enviro, said, “This has been a great experience for me and I'm glad to be amongst the top three winners. This unique platform will help us to scale our business and we are looking forward to working with the jury to prepare our five-year business growth plan.”

According to Gaddam Ranjith Reddy, Managing Director, Rohini Minerals, it was a tough competition wherein CEOs of midsize businesses gave their best shot. However, he felt that it was awesome to be amongst

radhika.ktp@expressindia.com August 16-31, 2013

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ERA significantly accelerates turnaround time for proficiency testing results New process reduces waiting period from twenty-one days to two days nvironmental Resource Associates (ERA), a Waters Business, recently completed a ninemonth project to significantly reduce the turnaround time for reporting laboratory proficiency testing (PT) results. ERA’s innovative new process will allow customers to know within two business days of a study close if they pass or fail a proficiency test – nineteen days faster than before.

It is imperative that laboratories receive reliable PT results as quickly as possible. Laboratories rely on proficiency tests to signal potential quality issues within their facility. A failed proficiency test could be an indicator of a problem

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with testing methodology, instrument, or an analyst’s performance.

Dr Carl Craig, President, ERA, who was a driving force behind the development of the new process explained, “A laboratory’s PT results drive key decisions in the areas of air and water quality, healthcare, environmental management, food safety, and laboratory operations.

Having faster access to study results is absolutely critical because of the larger implications when testing drinking water, air pollutants or waste water.”

The two-day report turnaround is effective with ERA’s monthly proficiency testing studies that include water pollution, drinking water, air and emissions, and soil. In addition, laboratories

HAVING FASTER ACCESS TO STUDY RESULTS IS ABSOLUTELY CRITICAL BECAUSE OF THE LARGER IMPLICATIONS WHEN TESTING DRINKING WATER, AIR POLLUTANTS OR WASTE WATER and facilities that participate in ERA’s study for the annual Environmental Protection Agency’s Discharge Monitoring ReportQuality Assurance (DMR-QA) programme will receive their study results in two business days.

“Whether it’s a college student waiting for test scores or a patient waiting

on a biopsy result, improvements in technology and data processing have allowed results to be returned quickly in many other areas.” Craig added, “I put the challenge out to the ERA team last year to reduce the report turnaround time and they delivered in a big way.”

EP News Bureau-Mumbai

PRODUCT Fisher Scientific launches new imaging system for life science applications hermo Fisher Scientific has launched Thermo Scientific myECL Imager.

T The myECL Imager revolutionises the capture and analysis of chemiluminescent western blots, stained protein gels and nucleic acid gels by simplifying the entire imaging workflow.

The myECL Imager incorporates advanced CCD technology that results in greater than two times the sensitivity of X-ray film, with 10 times the dynamic range. The intuitive touchscreen controls with on- board computer simplify the image acquisition process. The improved sensitivity and small instrument footprint makes the myECL Imager an effective substitute for the laboratory darkroom.

The Thermo Scientific myAnalysis Software supplied with the instrument provides a suite of programmes to analyse nucleic acid or protein images, including automatic lane and band identification and molecular weight overlay analysis programmes.

The myAnalysis Software saves image files in a non-proprietary format for easy sharing with colleagues. Images and data reports can be exported directly to Microsoft Word, Excel and August 16-31, 2013

Powerpoint for further analysis and presentations.

Contact details: Somesh Pandey Segment Marketing Manager Fisher Scientific – Life Science Thermo Fisher Scientific India Pvt. Ltd.

www.expresspharmaonline.com

403-404, Delphi "B" Wing, Hiranandani Business Park, Powai, Mumbai - 400 076 Phone : +91 -22 -67162283 Mobile: +91 - 7738009544 somesh.pandey@thermofisher.com www.thermofisher.co.in and www.fishersci.in EXPRESS PHARMA

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Cognex launches low cost pharma code readers ognex Corporation has introduced a range of low cost pharma code readers. The ‘L (Linear)- Series’ of Cognex low cost readers has quickly become the preferred barcode reader due to its outstanding read rate performance, ease of use and cost effectiveness.

Pharma code reading plays an integral part in the pharma industry.

Within the pharma industry, stringent legislation exists to combat counterfeit goods by ensuring each product can be traced throughout the supply chain.

In order to achieve the required levels of traceability, manufacturers are increasingly reliant on printed 2-D codes combined with advanced code reading technology.

Cognex DataMan 50L and 300L series has quickly become the preferred barcode reader due to its outstanding read rate performance and ease of use.

The key features of DataMan 300L are: They are easier to use for multiple applications; greater customisation and control; lighting options include; polarised red for reflective parts or parts under plastic; blue for metal parts or barcodes printed in colour; highintensity red for general purpose applications; Cognex custom high-powered

The key features of DataMan 50L are: unmatched read rate performance; no moving parts; no read analysis

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illumination accessory (HPIA) for long-range barcode reading applications; several external lights powered directly from the reader, including the ring, spotlight, low angle ring and DOAL; reduced need for additional hardware; automatically adjusts to optimal settings.

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

Ambetronics launches multi-used data logger mbetronics has launched multi-use data loggers with EBI-300 faily in two different range. EBI-300 T (-30°C to 60°C) & EBI-310 (-35°C to 75°C) with external probe (200°C to 250°C). This logger allow documentation in pharma and food industry according to EN 12830 standard. It is pre-configured or it can be configured by the user.

The main application is

A

using storage of samples in refrigerators/freezers and transportation. As important as the ease of use is the security of the produced reports.

EBI-310 logger creates files in PDF/A 1b format which delivers the security required to eliminate the possibility to manipulate the recorded data. This security meets the requirements of the pharma industry with GMP

compliant. The EBI-310 data logger is waterproof and offers the flexibility of wide temperature measurement range from -30°C to 75°C an accuracy of ±0.2°C with storage capacity upto 1,20,000 values.

Contact details: Ambetronics Engineers Ashish Shah -Managing Director

17-B, Tarun Industrial Estate, Mogra Pada, New Nagardas Road, Andheri (E), Mumbai – 400069, India Tel: +91-22-66995525, 28371143 Fax: +91-22-28226570 Cell: +91-9821062102 E-mail: ashish@ambetronics.com Web: www.ambetronics.com

Fisher Scientific launches new device for rapid semi-dry transfer two midi gels at once; excellent for fast or traditional semi-dry methods.

he new Thermo Scientific Pierce G2 Fast Blotter, designed specifically for rapid five-minute (or traditional one-hour) semi-dry transfer of all sizes of proteins from polyacrylamide gels to nitrocellulose or PVDF membranes in five to ten minutes.

The product has the following features: fast, five to ten-minute transfer; efficient for small, medium and large proteins alike; integrated power supply for seamless control; easy-touch programming for any protocol; transfer up to four mini gels or

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Contact details Fisher Scientific (Part of Thermo Fisher Scientific) 403 - 404, B Wing, Delphi, Hiranandani Business Park, Powai, Mumbai - 400076. India Email:somesh.pandey@thermofisher.com Web: www.fishersci.com

www.expresspharmaonline.com

August 16-31, 2013

Express Pharma Business Avenues

UNIPACK MACHINES PVT. LTD. UMP

AN IS/ISO 9001:2008 Certified Company

UNIPACK UNIPACK LAUNCHES ITS LATEST NEW PRODUCT POLYPROPYLENE PLATE & FRAME TYPE FILTER PRESS ANYTHING IN FILTRATION WE HAVE A SOLUTION

FOR LIQUID SOLID SEPARATION

FILTER PRESSES - FILTER PLATES

RECESSED (Chamber) Plates

POLYPROPYLENE Filter Plates & Frames

MEMBRANE Filter Plates

APPLICATION OF FILTER PRESSES Dyestuffs : Dyes, Dyestuff, Pigments, Intermediates for dyes etc.

Chemicals : Basic Chemicals, Organic & Inorganic Chemicals, Phosphoric Compounds, Agro Chemicals, Pesticides and Others.

Food Industry : Food Colours, Starch & Glucose, Fruit Juice, Squashes, Edible Oil, Palm Oil, Rice Bran & Glycerine.

Mining & Metallurgy :Zinc, Copper, Nickel, Cobalt, Silver, Electroplating & Non Ferrous Metal, Mineral Concentration, Pollution:

Flotation tailings, Ceramic products and others.

Effluent Treatment, Sewage Treatment, Industrial Waste Water Recycling, Sludge Dewatering Resulting from: Pickling Plants and galvanic plants, Industrial water and Potable water treatment plants, Dust scrubbers, Industrial sludge dewatering plants, Municipal sludge dewatering plants.

Redg. Off. 8 Krishna Mahal, 2nd Floor, ‘D’ Road Churchgate, Mumbai 400 020 Tel: +91 22 2281 2918 / 2281 0408 Works: Agarwal Ind Estate, No. 6, Unit No. 2, 3, 8, 9 & 10, Sativali Road, Village Waliv, Vasai (East ), 401 208 Dist Thane, Maharashtra INDIA Telfax: +91 250 2453 967 / 2455 449/ 2453 580 Email: ump1990@gmail.com. Website: www.unipackmachines.in August 16-31, 2013

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Express Pharma Business Avenues

The Best Prescription SOLUTIONS High Purity Water Generation and Distribution Systems RO-EDI Systems I Swift Demineralisers I Distribution Systems I Ozonation for Loop Disinfection

Your Benefits: Total Solutions from a Single Source

Speciality Products for Formulations & API Pharmaceutical Grade Resins I Adsorbent Grade Resins I Polymeric Adsorbent Resins I Speciality Activated Carbon

Total Water Management Water/Effluent Treatment & Recycle I O&M of Complete Water Systems/Circuits I Management of Cooling & Boiler Water Treatment

Lower Cost of Ownership Lower Cost of Operation All India 24x7 Comprehensive Service Backup

E-mail: pharma1@ionexchange.co.in • Website : www.ionindia.com Ion House, Dr. E. Moses Road, Mahalaxmi, Mumbai - 400 011.

Call 3989 0909 in Mumbai, Delhi, Kolkata & Chennai; prefix 022 from other cities.

We care for your family . . .

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

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

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

Papain Pepsin Pancreatin Protease ( acid / alkali)

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

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

August 16-31, 2013

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Creative and

reliable

?

DC formulation Yes – with Roquette Our directly-compressible polyols, such as mannitol DC and, now also, sorbitol DC, xylitol DC and maltitol DC, offer the flexibility you need for formulations that open up markets.

Aroma. Texture. Sweetness.

Whatever it takes, Roquette gives you the keys to creativity and reliability.

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

August 16-31, 2013

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Express Pharma Business Avenues

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

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

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

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Wash Down Hose Station

SIP MODULE

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

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Top Tank / Reactor Sampler

Flush Bottom valve August 16-31, 2013

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Product Range Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

Parksan Filters Pvt. Ltd.

103, Laxmi Industrial Estate, Navghar, Vasai Road (East), Dist. Thane - 401 210, India Tel : +91 250 239 1904 Mob : +91 98338 83114 Email : sales@parksanfilters.com Web : www.parksanfilters.com parksan@vsnl.net

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SILICONE TRANSPARENT TUBING F O R H I G H P U R I T Y APPLIC AT IONS

DMF NO: 26710

1 1 1 1 1 1 1 1 1 1 1 1 1

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Vijay Kulkarni 09940047667 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: A K Shukla 09849297724 ■ Kolkata: Ajanta / Prasenjit Basu 09831182580 / 09830130965 ■ Ahmedabad: Rajesh Bhatkal 09821313017

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August 16-31, 2013

Express Pharma Business Avenues ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Quality in our genes…

Identification and quantification of Organic process impurities by LC-MS/MS – GCMS/MS.

Genotoxic impurity quantification Genotoxic Studies.

1. Sub chronic oral Toxicity 2. Bacterial Mutation Assay.

3. Micro Nucleus test 4. Bone marrow chromosome aberration test.

Inorganic impurities by ICP-MS and A.A.S with Graphite furnace, IC Solvent impurities by GC-MS/MS and GC head space with MS.

Qualification of Impurities.

Degradation products Method Validations as per ICH Guidelines Extractable and Leachable studies INVITRO safety STUDIES Polymorphic studies by XRPD. Protein impurities by capillary Electrophoresis.

TECHNOLOGIES FOR IMPURITY PROFILE STUDIES

ACCREDITATIONS

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

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

Data Management practices in SIPRA LABS are designed to ensure total integrity, security and fastest retrieval.

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

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

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Bulk Density Tester Measures the bulk density of fine powders and similar products USP, ASTM Compliance Patent Pending

Mechanical Spatula Removes Excess Powder

www.electrolabindia.com

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info@electrolabindia.com August 16-31, 2013

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August 16-31, 2013

LOSING

GROUND? Once respected by the physicians for his repertoire of knowledge, is the medical representative of today, reduced to being just a salesman? Shalini Gupta takes a look at the profession

August 16-31, 2013

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P Place: OPD at a leading hospital, Time: 5 pm. As the patients move in and out of the doctor’s cabin, a group of four men sit huddled together with heavy brochures of a leading pharma MNC. They discuss with each other while anxiously waiting for his personal assistant to let them in for a meeting as they hope of making their elevator pitch, rehearsed and prepared for that very moment. This is just one slice out of the daily grind of a Medical Representative (MR), who to a large extent is a pharma company's most onground person when it comes to sales.

The front salesman With as high as 98 per cent of the staff hired at entry level in a pharma company consisting of MRs, they form a large chunk of the field force that is deployed. Just like the pawn in a game of chess, their responsibility is to be at the frontline, interacting with the doctors, who play a key role in doling out prescriptions, on which drugs from pharma firms if there consistently, could send cash registers ringing. However, it is not as easy as it sounds.

“There are roughly 26,000 pharma companies and 7.5 lakh doctors, However, companies may direct MRs to

THAMMAIAH BN

ASHISH DUTT

TIMOTHY EJ

Director, Kelly Scientific Resources & Kelly IT Resources

Chief Operating Officer, BioQuest Solutions

started his career with Pfizer as an MR in 1984

70 per cent of those hired are science graduates and the rest from a nonscience background.

Some MNCs may also hire MBAs or engineering graduates depending on the profile in question

These are changing times the industry is going through.

Companies need to come out of their marketing myopia and look at the business in a larger perspective, shifting their focus from selling to healthcare

With most information being available on the Internet for the doctor, shorter training programme or on the job training in some cases and targets being the only focus, the MR visit becomes a mere formality instead of a serious discussion

target only 25 per cent of these physicians who might be seeing the maximum number of patients (and hence more prescriptions) or maybe even opinion makers (even though they may not be prescribing),” chips in Ashish Dutt, Chief Operating Officer, BioQuest Solutions. And if you thought, less physicians would make the going easier, let us first understand the job profile.

Typically, as the name suggests, an MR is the sales representative of a pharma company and is required to ensure that doctors have his company’s drug brands topmost on their recall. With branded generics forming a considerable part of prescriptions, this is the single-most important task but also the most difficult with majority of the companies selling the same molecule but under different brands as

high as 50-60. Since there is no novel research or new facts that he can share with the physician, price points can be critical to pique the interest.

The selling can be more on the consultative side should he represent an innovator company. He could share new studies and research papers, even discuss these along with the drug side effects if any, efficacy etc. Setting targets for territories and managing the supply chain by ensuring that the nearby chemist shops are well stocked are others.

“Competitive intelligence though is the key,” adds Dutt.

Knowing if a doctor has shifted from brand X to Y, elucidating how the drug is different from its peers in clinical trials, even dispensing information on competitors.

“Up to 70 per cent of those hired are science graduates

and the rest from a non-science background. Some MNCs may also hire MBAs or engineering graduates or those with specific qualifications depending on the profile in question. But typically, most companies into branded generics are looking at sales competency,” enumerates Thammaiah BN, Director, Kelly Scientific Resources & Kelly IT Resources. Most of them may spend upto five years before becoming a manager and may even specialise in a drug division, for instance cardiovascular, diabetes etc, he adds.

Then and now Inspired by his elder brother, an MR himself, Timothy EJ, began his career at Pfizer in 1984 at a salary which was higher than what a bank officer commanded those days.“ I

A day in the life of an MR in the 80s ❖

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Carry the list of doctors to be met, latest feedback on them from the related chemist, the interaction that took place in the last visit, the strategy for the products to be detailed, the samples or any related document to ensure conver-

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sion to sales of these set of doctors in a bag based on a tour plan submitted at the start of the month, since there were few landlines and no mobile/Internet Travelling and waiting for calls for one third of the day.

❖

Normally this is the time utilised to upgrade your knowledge.

On reaching the territory, conduct a detailed survey of the retailers to find the latest Rx habit, impact of our last call, any fresh orders had to be

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❖

done. Equipped with this information, go and meet the doctors.

The day ended with report writing that needs to be posted daily.

August 16-31, 2013

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was quite impressed with the way he carried himself; neatly ironed clothes with a tie and at times a coat. The fact that he was rubbing shoulders with the respectable doctors’ community was only part of the motivation. Not to mention the generous extra pocket money he always shelled out for my college outings (which I later learnt was because of the allowances in addition to salary and incentives he earned).” He worked under Sam Varkey, his Sales Director, who himself joined the company as an MR in 1960. That is how most top management started out. Of course MBAs were not a rage back then.

Today MRs earn `2 to 3.5 lakhs annually depending on the company that employs them. Incentive as a component of the CTC can be as low as 15 per cent or even be twice as much as the salary itself, adds Thammaiah.

Attrition levels hover between 12 to 13 per cent, and while this may not be a cause for concern, one would closely need to watch the numbers because the pressure seems to be building up. 30 years back there were only two or three competitor brands as compared to 50-60 brands of the same generic name. The doctors’ time is also at a premium with most of them cutting

down on the time for MRs to as less as once a week seeing only five MRs or even less.

While most may have their elevator pitch handy, getting a physicians interest is a tough ball game. And that is only the tip of the iceberg.

“With most information being available on the Internet for the doctor, shorter training programme or on the job training in some cases and targets being the only focus, the MR visit has become a mere formality instead of a serious discussion. The respectful relationship building with knowledge and skills driving business of yore is missing,” laments EJ. Better training, at least for a month, followed by regular on-the-job coaching by the managers and frequent evaluation during the quarterly review meets was the norm earlier, he adds. Lack of rigourous training and overnight results makes it tough. The growing focus on incentives leads to trading (less convincing but more enticing for the doctor and chemist) rather than building business through knowledge and skill, which might explain the short duration most MRs spend in companies.

Technology to the rescue?

In 1980s with no Internet access, limited access to jour-

nals and less flourishing private practices, the dependence of doctors on MRs was high.

But today, there is a deluge of information on the net and hence what the MR might need to dispense now has to be exclusive and unique. But that also spells opportunity.

He could use direct mail, voice mail, web, iPads, smart phone applications, etc. rather than the routine face-to-face meeting at a clinic to step up the communication. This also translates into flexibility in plans when the need arises.

While earlier any query handling or information required would take time, today the entire document can be downloaded and passed to client.

His own development can be strengthened through elearning platforms, CRMs can be used for better planning and making more effective calls, suggests EJ. However, the key is perseverance and willingness to spend time for his own development and the willingness of the organisation to do the same. “This will ensure that he does not remain a trader but scientifically engages the doctors and makes himself a valuable asset to the organisation,” he says.

And then, there are companies which are exploring unique marketing solutions given budget restraints and focus

on higher engagement.

BioQuest’s deTab solution (iPad detailing) is one such tool which has enhanced field force engagement for pharma companies.

Exhorts Dutt, “These are changing times the industry is going through. Companies need to come out of marketing myopia and look at the businesses in a larger perspective, shifting their focus from selling to healthcare.” In a case study, the solution helped a pharma company target more than 25 per cent of the physician population by effectively engaging them and building their interest while collecting data simultaneously. Does this signal the end of the road for an MR? Maybe not. But something needs to be done to help regain the lost lustre of the profession. EJ recounts an incident during his days as an MR where his discussion with a leading GP in a small town got a little lengthier and an impatient patient barged in.

Knowing it was not a serious situation, the doctor got up and told the patient, “I am able to treat better because of people like the gentleman sitting here. He updates me with the latest information on the drugs and other medical products. You should be thankful to him.” shalini.g@expressindia.com

INITIATIVE United Way of Mumbai and AmeriCares India commemorate World Hepatitis Day Organises communitybased awareness activities with support from Bristol Myers Squibb Foundation at slum areas in Mumbai

August 16-31, 2013

n the occasion of World Hepatitis Day, NGOs in Mumbai - United Way of Mumbai and AmeriCares India Foundation, came forward to educate and spread awareness among slum communities in Mumbai. Rallies and street plays were organised at the Korba Mitha Nagar slum in Wadala, Mogarapada slum in Andheri and Ayodhya Nagar slum in Chembur.

The community-based awareness in Wadala, Chembur and Andheri with Green Ribbon Brigadiers is part of project PAHAL being implemented by United Way of Mumbai, AmeriCares India Foundation and National Liver Foundation with support from the Bristol-Myers Squibb Foundation.

The rallies were organised

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simultaneously in all three places – 160 student volunteers across six city colleges – St Andrew’s College – Andheri, Niranjandas Machitdas College - Andheri, Guru Nanak College - Wadala, SIWS College – Wadala Sydenham College – Chembur, Jai Hind and Rajiv Gandhi College – Chembur. Students carried placards, posters and banners as a way to spread awareness about hepatitis; with the theme this year being 'Hepatitis. Know it. Confront it.…'. They also carried out door-to-door interactions in the communities to educate the community members with basic information on hepatitis infections.

Jayanti Shukla, Executive Director, United Way of Mumbai said, “World www.expresspharmaonline.com

Hepatitis Day provides an opportunity to focus on specific actions including raising awareness on all forms of viral hepatitis as well as confronting the stigma and discrimination associated with these diseases, among others.

The participation at this event today is encouraging and we hope this is a step in the right direction to plan and implement more knowledge-based preventive approaches in

India.”

Dr Swati Jha, Program Director, AmeriCares India Foundation added, “Together hepatitis B and C affect 500 million and kill approximately one million people every year.

Through such initiatives we are trying in spread awareness among the people and with a goal of helping them make better decisions regarding their health.”

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AWARDS SABRE Awards 2013 Certificate of Excellence for Sanofi Diabetes Blue Fortnight 2012 Numerous activities were conducted in over 64 Indian cities and around 10 million diabetics were reached out through this campaign

he Sanofi Diabetes Blue Fortnight 2012, India’s largest diabetes awareness campaign, an initiative by Sanofi and HEAL foundation, in association with Ministry of Health & Family Welfare India, International Diabetes Federation and Archaeological Survey of India received Certificate of Excellence during the SABRE awards 2013 in three categories. The categories were public education, healthcare and public sector/government.

With the theme of ‘Every

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Voice for a Better Future’, Sanofi and Heal Foundation brought together various stakeholders in diabetes management - physicians, corporate, NGOs, media and patients to garner their individual expertise in a combined effort to enhance diabetes prevention, education and management. The activities were designed to ensure a 360 degree outreach. The campaign reached out to an estimate of 350,356,238 people in the country.

Numerous activities were conducted in over 64 Indian

cities and around 10 million diabetics were reached out to through this campaign. A pledge for diabetes care was taken by more than 20,000 doctors across India. Over 180 key monuments and buildings were lit up in blue across the country.

The campaign saw participation of over 52,000 people in offline and online activities.

Conceptualised and executed by VIA Media Health Communications, it was the only campaign to receive three Certificates of Excellence.

EP News Bureau-Mumbai

Quintiles India wins Gold Sabre Award Bags award for excellence in public relations programming in the employee communications category

uintiles India’s entry, ‘Engaging Employees Through A Challenging Transition’ has won the Gold Sabre Award for excellence in public relations programming in the employee communications category at the inaugural 2013 Sabre Awards India ceremony held in Delhi. Instituted

by The Holmes Report that provides the most sophisticated reporting and analysis on public relations trends and issues globally, the Sabre

Q

Awards are a global benchmark for public relations work. The Holmes Report joined forces with the Public Relations Consultants Association of India to launch the Sabre Awards India to showcase the best of India's public relations work.

Quintiles India’s award winning entry focused on a carefully orchestrated communication campaign that was rolled out in 2012-13 for the Bangalore office consoli-

dation, an exercise that involved the transition of around 1700 employees from five locations in Bangalore to one facility in the city. It was a communication campaign that combined traditional channels with digital channels via the organisation’s awardwinning corporate intranet, iQ, to engage and excite employees. The entries were judged by well known professionals across public relations firms and corporate organisa-

tions in India.

“This is fantastic news. I am so glad that the project team's investment and creativity in using various communication approaches to engage employees from the start of the project to the completion paid off handsomely with this Gold Sabre award recognition,” said Dan Kum, Vice President, Real Estate and Facilities, Quintiles Apac.

EP News Bureau-Mumbai

CAMPUS BEAT SCOP organises AICTE sponsored faculty development programme More than 50 faculty members from different institutes participated in the event

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inhgad College of Pharmacy (SCOP), Vadgaon (Bk), Pune recently organised AICTE sponsored two weeks faculty development programme on Research and Practice in Metabolic Disorder: Past, Present and Future. More than 50 faculty members from different institutes in and around Pune actively participated in the event Dr KN Gujar, Principal Sinhgad College of Pharmacy designed this faculty development programme, which was inaugurated by Dr AG Unikrishnan, Chief Executive Officer and Chief

S

Endocrinologist at Chellaram Diabetes Centre, Pune.

During the entire fortnight, academicians, scientists and medical practitioners made intensive deliberations and shared their experiences to increase the awareness amongst the pharmacy teachers about the limitations of current therapies for the prevention and management of various metabolic disorders and related co-morbidities. An attempt was made to discuss the changing epidemiology of obesity and metabolic syndrome with emphasis on role of lifestyle, pharmacological, traditional, surgical, and www.expresspharmaonline.com

novel approaches to control the situation.

The coordinator of the programme, Prof Dilpesh Jain, SCOP, also arranged a visit to Pioneer Diagnostic

Centre and Chellaram Diabetes Institute to explore the latest in technology for diagnosis and treatment of metabolic syndrome.

EP News Bureau-Mumbai August 16-31, 2013

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.