Express Pharma (Vol.10, No.24) October 16-31, 2015

VOL. 10 NO. 24 PAGES 60

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Research Boehringer Ingelheim: Driving new respiratory treatments

16-31 OCTOBER 2015,` 40

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CONTENTS Vol.10 No.24 OCTOBER 16-31, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

MARKET

AUTOMATION THE NEW NORM FOR GROWTH Automation in the pharma packaging machinery is helping the drug manufacturers to not just increase volumes but also to make their products more safer, efficient and appealing.

By Sachin Jagdale | P17

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ONLINE CLINICAL TRIAL APPLICATIONS MAY BE MANDATORY SOON

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DELHI HC UPHOLDS MSD’S SITAGLIPTIN PATENT

RESEARCH

Bengaluru Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua

26 30

Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P23: INSIGHT Compulsory Licensing – Is it a non-starter or a failure of the nation?

PHARMA ALLY

‘IO125 WILL BE IN CLINICS IN 2017’ BRISTOL-MYERS DRUG GETS FDA APPROVAL

MANAGEMENT

P26: NEWS Boehringer Ingelheim: Driving new respiratory treatments

P32: INSIGHT

31

‘GROWTH IN BUSINESS ACTIVITY INITIATED US TO EXPAND OUR ACTIVITIES IN INDIA’

35

WATERS’ CENTERS OF INNOVATION PROGRAM HONOURS OHIO STATE UNIVERSITY LABORATORY

Ready for a makeover: What’s trending in the global pharma logistics?

P56: APPOINTMENT Dr Bhaskar Chaudhuri and Alan Rosling join Vyome Biosciences’ board of directors

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‘THERE IS A NEWER FORM OF RACIAL DISCRIMINATION IN THE MEDICAL PROFESSION'

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

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

EDITOR’S NOTE

Balancing the scales

T

he Delhi High Court (HC)'s October 7 decision to uphold Merck Sharpe and Dohme (MSD)’s patent on anti-diabetes drug sitagliptin and its salts is being seen as proof that India’s patent authorities are capable of unbiased decisions.

Spicy IP’s Shamnad Basheer in fact advises the Modi government to ‘flaunt this decision to our US counterparts who’ve been ranting against the Indian IP system.' (http://spicyip.com/ 2015/10/a-madhu-victory-for-merck-busting-thepatent-bias-myth.html).

Will these measures discourage generic manufacturers from challenging patents in the future? Not likely. Glenmark is not the only pharma company to challenge MSD’s patents on sitagliptin phosphate monohydrate and was taking its cues from Teva Pharmaceuticals in this instance. The 133-page Delhi HC judgement details that MSD’s patent for this salt faced opposition from the European Patent Office and the WIPO on the grounds that it lacked novelty and inventive step but the original applicant argued the sitagliptin phosphate monohydrate had remarkable advantages over the hydrochloride salt in terms of chemical stability (which allowed it to manufacture tablets better). MSD (as Merck) was granted a European Patent for sitagliptin phosphate monohydrate which was challenged by Teva Pharma on the same grounds of lack of novelty and inventive step, but its challenge was rejected by the EU authorities.

Which begs the question, what made Glenmark confident that it had a good chance of a win, given Teva’s experience? Was it relying on previous decisions in similar cases, where the impression is that Indian courts tended to rule in favour of the local company? Glenmark’s case initially seemed strong as Merck had voluntarily abandoned its patent application for the phosphate monohydrate salt in India as well as other patents, which earned it a rap on the knuckles from the Delhi HC. This case dragged on for more than two years and would have continued at the same pace, but for the Supreme Court (SC)’s monitoring and strict diktat dated May 15 this year to expedite matters.

(For more details of the Delhi HC judgement, see http://www.financialexpress.com/article/ pharma/latest-updates/delhi-hc-upholds-msds-

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Besides the balanced reasoning within the Delhi HC judgement, it is the SC’s intervention which could see this case go down as a major milestone

sitagliptin-patent/147743/).

Future patent challengers need to take note of this increased scrunity and be aware that the SC could step in whenever required in future as well. Which means that patent challengers cannot rely on using the interim injunction period to sell stocks already in the market, or as some market analysts point out in Glenmark’s case, launch a replacement product. Besides the balanced reasoning within the Delhi HC judgement, it is the SC’s intervention which could see this case go down as a major milestone in the evolution of the Indian intellectual property disputes, specifically in the pharmaceutical universe.

The judgement came just a few days after the signing of the Trans-Pacific Protocol (TPP), between 12 countries, led by the US. The grouping includes seven countries in the AsiaPacific region (Vietnam, Malaysia, Japan, Australia, New Zealand, Singapore and Brunei), with a clear intention to draw these nations away from China. Health activists groups have criticised both the methods used to draft the agreement as well as the contents based on via leaked versions. Doctors Without Borders (MSF) said that even though the final leaked version was better than the initial versions, ‘the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharma companies.’

The full text of the TPP is due to be made public in a month’s time and it has yet to be passed by the US Congress, so all legal experts are holding back their analysis but from all accounts, the die has been cast. While India rightly chose not to be part of the TPP, primarily due to these concerns, we have to mitigate the loss of exports to these countries by quickly closing our own trade deals like the India-EU Bilateral Trade and Investment Agreement and the ongoing negotiations under the Regional Comprehensive Economic Partnership. The next few months could be crucial on this front and we hope India remains firm on its stance on IP issues within these agreements.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Online clinical trial applications may be mandatory soon CDSCO aims to attract global clinical trial in India Usha Sharma Mumbai CENTRAL DRUGS Standard Control Organisation (CDSCO) plans to go fully online for submission of applications for clinical trial registration in one month’s time.

The trial run of an IT-enabled system for online submission of clinical trial applications started in early September for the purpose of feedback/suggestions only, with physical submission of applications con-

tinuing as usual. Before making it mandatory, CDSCO has asked stakeholders to share their feedback and suggestions within a month’s time.

Dr GN Singh, Drugs Controller General of (India) said, “Before going fully online, we have introduced the first phase of an IT-enabled system for online submission of clinical trial applications as a trial run. And asked the industry to raise technical difficulties so that we can rectify issues before going fully online.”

In order to improve transparency, accountability and efficiency in processing of clinical trial applications and monitoring, CDSCO with the approval of Ministry of Health and Family Welfare, Government of India has taken the initiative to create an IT-enabled system for online submission and processing of applications as well as monitoring of clinical trials in the country. The objective of the software is to simplify the application process and also to be user friendly.

Reactions to the newly launched initiative have already started coming in. For example Singh reveals, “We recently received a query from the US that they are finding it difficult to open the page for online submission of clinical trial applications. To resolve this issue, we have instructed the NIC team to fix the issue as early as possible.”

In March 2015, the CDSCO issued an office memorandum for nomination of representatives for e-governance and dig-

italisation of services at the CDSCO. It has initiated a comprehensive e-governance programme for filling online applications, processing of application, issuance of licenses/permissions/approvals/NOC’s and tracking of the status of applications for various purposes. Centre for Development of Advanced Computing (CDAC) was entrusted the job to develop the required software. u.sharma@expressindia.com

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MARKET

Delhi HC upholds MSD’s Sitagliptin patent Glenmark accepts decision, evaluating legal options RULING IN favour of US drug major Merck Sharp and Dohme (MSD), Delhi High Court has restrained Mumbai-based Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs, Zita and Zita-Met, saying it has infringed the former's patent on the main ingredient, Sitagliptin.

'Injunction allowed,' Justice A K Pathak said and added that MSD shall be entitled to actual cost of the proceedings.

"In view of the finding returned on the above referred issues defendant is restrained by decree of permanent injunction from making using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone or in combination with any other drug thereby infringing patent of plaintiff

The bench had, however, on Glenmark’s oral plea to allow it to sell its goods already in the market, clarified that it “may sell such of the products which are already in the market” (MSD)," the court said. Earlier, in an interim order, a division bench of the High Court had restrained Glenmark from making or selling its drug, used for treatment of Type-II diabetes.

The bench had, however, on Glenmark's oral plea to allow it to sell its goods already in the market, clarified that it "may sell such of the products which are already in the market i.e in possession of its distributors and retailers".

However, while granting the injunction, the HC did

not say anything about sale of existing stock.

MSD in its plea had sought injunction against Glenmark alleging that the latter had violated its IPR over its anti-diabetes medicines, Januvia and Janumet, by launching drugs containing the same salts.

The US firm had said it had invented 'Sitagliptin' salt used in its anti-diabetes drugs and has a patent over the molecule.

Glenmark, on the other hand, had contended that it

has used 'Sitagliptin Phosphate' in its anti-diabetes drugs, Zita and Zita-Met, and US firm has no patent right over this salt.

Glenmark had said that Sitagliptin Phosphate has been a distinct product from Sitagliptin and due to this, MSD had obtained separate patent for Sitagliptin Phosphate in the US. MSD first applied for a separate patent for Sitagliptin Phosphate in India and later abandoned it, Glenmark had said.

On its part, the US drug firm had said its anti-diabetes drug Januvia is not costly at `43 a pill which is roughly 1/5 th of its price in the US. MSD has welcomed the decision of the Delhi HC. While accepting the decision, Glenmark's statement said it was 'evaluating legal options.'

In 2014, MHRA had carried out more 550 inspections in the UK and 125 in non-EU countries, 49 of which were in India. The India Brand Equity Foundation states that the Indian pharma sector accounts for about 2.4 per cent of the global pharma industry and is the third largest in terms of volume.

GROWTH MOMENTUM of the domestic pharmaceutical sector is likely to sustain in the near-to-medium term owing to steady demand witnessed across therapy segments, regular new launches and price hikes taken by companies, a report by rating agency ICRA said.

With steady demand being witnessed across therapy segments, regular new launches and price hikes taken by companies in line with Drug Price Control Order (DPCO) guidelines, ICRA expects growth momentum to sustain in the near-tomedium term.

The regulatory risk of additional therapy segments being brought under control remain a concern with NPPA proposing to bring at least 100 more drugs under control by making corrections to DPCO 2013, ICRA said.

After experiencing moderation in the growth momentum in FY 2014 on back of price cuts and trade related disruptions, the growth in the domestic pharma industry bounced back with the industry registering a growth of 12.9 per cent on MAT basis as on March 2015 and 14.3 per as on June 2015.

Much of this recovery has been led by price hikes implemented by companies in their National List of Essential Medicines (NLEM) portfolio, stabilisation of supply related issues, and increased market penetration.

The lifestyle-oriented therapy segments have continued to grow steadily, which along with increased focus by companies towards introducing new products and enhancing field force productivity has also contributed to the growth momentum.

PTI

EP News Bureau-Mumbai

PTI

India, UK health regulators sign MoU The central understandings of the agreement include promotion of each other’s regulatory frameworks, requirements and processes WITH AN aim of improving public safety in the UK and India, a MoU was signed between the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare of India and UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The central understandings of the agreement include promotion of each other’s

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regulatory frameworks, requirements and processes.

“The MoU is going to create a new platform where patients will be given utmost importance. Quality medicine, affordability and transparency will be the tools for making medicines available to the people of the two nations,” Drugs Controller General (India), Dr Gyanendra Nath Singh said.

It will help in exchange of

information and opportunities for technical cooperation, assistance for better equipment to protect the health of their respective publics.

“We operate in a global environment and agreements such as these serve to further strengthen our ability to promote good practises and we look forward to working even closer with our Indian counterparts,” Michael Rawlins, Chairman, MHRA said.

Pharma sector growth likely to remain strong: ICRA

EVENT BRIEF OCTOBER -NOVEMBER 2015 26

Summit on GMP, GCP and Quality Control

29

2nd Annual Data Integrity & Quality Metrics Workshop

19

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SUMMIT ON GMP, GCP AND QUALITY CONTROL Date: October 26-28, 2015 Venue: Hyderabad Summary: The 4th International Summit on GMP, GCP & Quality Control, will be organised by OMICS International around the theme ‘New Paradigm Approach for Manufacturing Excellence and Quality Standards.’

Contact details Ph: 040-47482222-47482200

2ND ANNUAL DATA INTEGRITY & QUALITY METRICS WORKSHOP Date: October 29 - 30, 2015 Venue: The Westin Mumbai Garden City International Business Park, Oberoi Garden City Summary: UBM will organise a workshop at CPhI will focus on the issues related data integrity, reliability and also on quality metrics and pilot programmes in the US. Experts from Lachman Consultants will be conducting the workshop.

Contact details UBM India E-mail: suvidha.shetty @ubm.com Web: http://globalformulation.com

ADVANCED TECHNIQUES & APPLICATIONS OF MASS SPECTROMETRY Date: November 19-20, 2015 Venue: Ramada Powai Hotel & Convention Centre, Mumbai, Summary: SELECTBIO will organise its 2nd international conference ‘Advanced Techniques & Applications of Mass Spectrometry.’ Experts will cover various advanced techniques followed by novel applications of mass spectrometry in analysis of pharmaceutical and forced degradation products, metabolites, food, environment, forensic, clinical and biological samples.

Contact details Sakshi Modgil Customer Services Manager, SELECTBIO India, Tel: +91 172 5025050 Mob: +91 7696 125050 Email: s.modgil@selectbio.com

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cover )

Globally, pharma companies are incorporating new generation packaging innovations like braille labelling for the visually impaired and smart blister packs for elderly patients. When will the trend catch on in India?

BY USHA SHARMA

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(

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cover )

T

hough pharmaceutical companies in India are always on the lookout for innovative packaging of medicines in terms of convenience and patient friendliness, they are still lagging behind when catering to certain segment like the visually impaired. The elderly segment is also neglected when it comes to senior citizenfriendly packaging.

Globally, several pharma companies have introduced advanced technology in their blister packaging which helps in monitoring the use of medication and patient compliance as well. There have been innovations in the pharma blister packaging where 'smart' blister packs incorporate moving colour advertisements with sound for partially sighted patients.

If the world is adopting newer packaging methods and technologies, why are Indian pharma companies lagging behind? Is the visually impaired population too small to be a significant market in India? This is not so. Ajit Kanetkar, Head Technical Cell, ACG TechnoVersity informs, “As per available statistics, India accounts for a staggering 20 per cent of the world's blind population, which is approximately 7.8 million. The visually impaired population, globally, is 285 million. Of these, 39 million are blind and 246 million have weak vision. Nearly 90 per cent of the visually impaired population lives in developing countries.”

No legislation = no initiative The European Union (EU) issued a directive in 2005 for pharma and packaging companies realising the urgent need for braille script on medicine packs for visually impaired people. The legislation (Article 56 (a) of council directive 2001/83/EC) requires that the product name, strength, and

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Since the braille script on pharma packaging is not a mandate in India, the technology advancement as well as education of the visually impaired in braille in this sector has been minimal Ajit Kanetkar Head - Technical Cell, ACG TechnoVersity

It's no wonder braille implementation takes a back seat in India in the absence of a legislation Chakravarthi AVPS Chief Executive Officer, Managing Director, Ecobliss India and Governing Board Member, INDIAN Institute of Packaging and Asian Packaging Federation

Drug ‘Price Control’ regulations are hampering investments in new plant and machinery to produce advance pharma packaging material MK Banerjee CDirector, C&I (Global), Essel Propack

nies in India have not followed suit.

Pointing out the key reason, Chakravarthi AVPS, Chief Executive Officer, Managing Director, Ecobliss India and Governing Board Member, Indian Institute of Packaging and Asian Packaging Federation stresses, “There is no legislation in India that braille has to be incorporated on the pharma packs. Obviously, companies see no big advantage and they are not pushing for it. It's no wonder braille implementation takes a back seat in India in the absence of a legislation.”

Kanetkar further says, “There are very few pharma companies that are looking at adopting this technology. Braille on pharma packaging is not a government mandate in India.

The Indian government is taking many gradual steps towards introducing braille script on pharma packaging through government and non-government bodies. In India very few blind people can actually read braille.

But since the braille script on pharma packaging is not a mandate in India, the technology advancement as well as education of the visually impaired in braille in this sector has been minimal.”

A pricey option

dosage appear in braille script on all pharma packaging.

Kanetkar says, “The EU regulation has been the guiding factor for pharma companies to introduce braille for any medical product for human use. The EU directive defines this ‘as any substance or combination of substances presented as having properties for treating or preventing disease in human be-

ings.’ This regulation has since led the way for other countries who are quickly following suit.

All EU legislation relating to pharma products is covered under the EE-A Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) have also implemented this directive.

Even countries like Brazil, the US and Canada have implemented a mandate for braille la-

belling on all pharma packaging.

The export markets like the EU and North America have braillecompliant pharma packaging, in line with the EU mandate (2005) and Can-Am Braille (2009).”

Though the EU directive for pharma packaging mandates the use of braille script and many countries have already implemented it, pharma compa-

Besides lack of regulations, cost also plays an important role. Replying to a query raised on whether Indian companies are running far behind in adopting advanced pharma packaging technologies, MK Banerjee, Director, C&I (Global), Essel Propack apprises, “I believe Indian companies are aware of the technology gap and new technological requirements to produce new generation pharma packaging material. However, drug ‘price control’ regulations are hampering investments in new plant and machinery to produce advanced pharma packaging material. Cost of new technology has to be plugged-in to fall within ‘price control’ formula.”

Since, there are limited pharma companies practicing in India, it also requires updated technical assistance. Kanetkar

( says, “Challenges for braille or pharma packaging are threefold. Firstly, there is an additional cost in upgrading the packaging machinery and be braille compliant. Secondly, braille dots need to be high enough to be easily read, but not too high that it perforates the packaging. The manufacturer must ensure that braille dots are not malformed or missing, while ensuring accurate spacing. And lastly, quality control is extremely critical in braille pharma packaging, for one misplaced dot could lead to costly lawsuits, high product recalls and tarnish the brand image.”

velop in a highly vision-impaired population country like India. We also have to wait for some mandate for braille on

pharma packaging. Once there is a directive from the government, the technology will develop further, making it easily

THE MAIN FOCUS

accessible and cost effective. If the government is able to put in place, some regulations for implementation followed by

education of the visually impaired in the braille script through multiple agencies, government and NGOs, then

Braille printing methods While informing about current printing practices against the braille script requirements, Banerjee says, “In order to print braille script (user instructions) print machinery has to be modified with in-line screen print units so that higher deposition of ink or varnish is possible.

Most of the primary and secondary packaging for pharma products are printed with either rotogravure or offset printing technology. Both these print technologies cannot deposit higher grammage of ink and varnish that are required to create braille dots.”

Kanetkar suggests, “Marburg medium should be used as the preferred braille font for pharma packaging, as recommended by the European Commission and other agencies worldwide. Also, specifying dot diameter, dot spacing, character and line spacing makes it easier for manufacturers of vision inspection systems to develop readers that automatically interpret the dots. The Indian government can set a global example by leading the introduction of expiry dates in braille, something that is not mandated anywhere else in the world.”

Additionally speaking about the implementation of braille on pharma packs in India, he says, “Although the braille script technology is gaining widespread usage in developed countries, it still remains to be seen how it will de-

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cover ) this situation may become the necessity that will drive the implementation.”

Looking beyond With the United Nations designating October 1 as 'Interna-

tional Day of Older Persons', it is apparent that global concerns for a rapidly ageing popu-

lation are only set to increase.

Indian pharma manufacturers also need to look into devel-

oping solutions for the geriatric population. In the last two to three decades, life expectancy cycle in India has been increasing which means the graph of the elderly population will certainly move upwards. So are we ready to tap this market?

Chakravarthi says, “India will see a rise in elderly population. But if one looks into the statistics, the number is far less than Europe and other developed countries. However, we need to seriously give a thought on compliance packs, and packs which are very user friendly. One has to really think of how effectively dose packs can be used by elders. We also need to focus on self administered drugs.”

Essel Propack is one of the companies which is an early mover when it come to developing senior friendly products.

Banerjee informs, “As we have been learning from the West and also Far Eastern countries, to cater to the demand of vast and growing elderly population, packaging designs have to be ‘senior citizen friendly’ so that one can open and/or dispense the unit dose conveniently by themselves.

We have developed ‘easy squeeze’ senior citizen friendly pharma tubes. We also have patented technology for ‘pill dispenser’ that facilitates the senior citizen dispensing of individual pill simply by tilting slightly downward and shaking the container. Likewise, we have patented as dispenser for controlling (prescribed) dosage of liquid drugs (syrup).

These basic innovations help senior citizens greatly and the inventors earn their blessings anonymously.”

It may take a long time to bring global technologies to the India market. However, our manufacturers can identify areas where alternative methods can be used to cater to the needs of each section of society. This could act as a differentiator as well as open up new market segments. u.sharma@expresssindia.com

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(

T

he pharma industry is facing constant pressure to increase production rates and improve efficiency, that too at lower operational costs. This pressure would inevitabley spill over to its allied sectors. Pharma packaging machinery industry is the one whose services are imminent for the growth of pharma companies. Over the years, the pharma industry has evolved and so has the pharma packaging machinery sector. The most significant change visible is the growing automation in these industries.

An evolving sphere Gone are the days when pharma packaging machines used to be bulky, noise-making and labour-dependant.

The new-age versions are relatively silent, light weight, computer software supported, and easy-to-operate. Packagers have understood the gains associated with improved equipment with time.

Today, industry experts feel that Indian pharma industry's success, to a great extent, is due to growing automation in the pharma packaging machinery.

Raj Menon, Founder, Karishma Pharma Machines, says, “In India, automation is a very recent development.

Cost of labour is very cheap, therefore as far as possible the tendency is to go for labour-intensive manual/semi automatic process. However, as more and more companies are now looking to export products, it is becoming mandatory to automate the production as per the cGMP standards. But the bottleneck is that we do not have qualified engineers to run the automatic machines.” Menon has over three decades of experience in the international marketing of pharma packaging machinery.

Anthony D’Souza, Direc-

THE MAIN FOCUS

AUTOMATION The new norm for growth

Automation in pharma packaging machinery is helping drug manufacturers to not just increase volumes but also to make their products more safer, efficient and appealing

To subscribe: bpd.subscription@expressindia.com

BY SACHINE JAGDALE

tor, Mespack India, opines, “Automation in pharma packaging is evolving very rapidly. Increasingly, sophisticated technologies and strategies are being employed. The competition for use of the valuable one-pack space is getting stronger than ever, especially in developing countries and some in developed countries.” He adds, “Advances in the packaging machines themselves has seen the incorporation of precise and accurate filling mechanisms, as the wrong dosage of a medicine could be life threatening.

Gentle handling is also essential and packs should be hermetically sealed for higher product safety. Highest regulatory compliance, hygiene design, flexibility, quick change over and easy change over are evolving at a faster rate than ever.” Mespack India is known for flexible packaging machinery, specialising in horizontal form-fill-seal technologies for flexible sachet, pouch and stick packs.

Automation in packaging machinery has not just helped with quick and quality production but also significantly cut down on the labour requirement. Though the speed of automation has picked up over the last one decade, according to Menon, it has also generated a sense of insecurity among labourers. This, in turn, could be hampering the growth rate of automation in the pharma packaging machinery sector.

Menon explains his point of view, “Worker resistance to automation is also another reason for the slow progress of automation in India.

Unions fear large-scale layoffs if automation comes in.

This is in direct contrast to Europe and the US where the workers themselves ask for more automation so that the work load will be reduced.”

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cover ) Automation, an answer to spurious drugs?

Governments across the globe are advising pharma companies to implement measures like track-and-trace mechanisms to curb the practice of spurious drugs. Though it will not guarantee complete security from spurious activities, it has been termed as one of the most effective solutions. Major pharma manufacturers are either trying to develop the technology internally or looking for partners.

Machine vendors are joining hands with track-and-trace solution providers in order to produce serialisation ready machines. Do these developments indicate that automation is the key to prevent the menace of spurious drugs?

Sandeep Kumar Goyal, Founder and CEO, Sanex Packaging Connections, says, “Not really, it all depends on what steps you take to handle counterfeit, automation simply helps to produce that.”

According to D’Souza, automation is provided to enhance production capability and making high quality product available to customer.

“Automation in totality can’t prevent spurious drugs but could help in providing packs of unique design and concept which are only possible through automatic mechanism, thus adding on to a support to prevent spurious drugs. Spurious drugs can be focussed by R&D of packaging division who could work on it, making pack unique and difficult to replicate,” points out D’Souza.

As more and more companies are now looking to export products, it is becoming mandatory to automate the production as per the cGMP standards

Automation is normally for higher volume and consistent business. So, it all depends on the type of products, its value and the total volume

Automation in pharma packaging is evolving very rapidly.

Increasingly, sophisticated technologies and strategies are being employed

Raj Menon

Sandeep Kumar Goyal

Anthony D’Souza

Founder, Karishma Pharma Machines

Founder and CEO, Sanex Packaging Connections

Director, Mespack India

manufacturers face increased cost pressures throughout the entire production and packaging process. As a result, packaging machines have to become more efficient and user friendly, offering flexibility, easy operation, robustness, intelligence, minimum wastage and protection from interference. By doing analysis of saving related to product wastage, packaging ma-

terial saving, spares cost, energy saving and manpower saving, the customer can easily conclude that highly automatic machines are the right option. Machines with best automation would guarantee minimum wastage, high productivity and maximum accuracy.”

The Indian pharma industry is touted to be the generic power house of the world. Along

with reputed MNCs and big domestic pharma companies there are thousands of small pharma companies operating in the country. Pharma companies with bigger size usually do not have investment-related issues.

Smaller companies deal with the local market, with comparatively limited production. So, with few exceptions, they may not require automated packag-

An expensive route to take?

Any new technology is generally considered expensive. Automation involves a number of experiments, unsuccessful attempts, investments for every new experiments etc. So, will automation of pharma packaging machinery be an expensive affair?

According to D’Souza, looking at the benefits offered by the automation, any automation related cost is justified.

He opines, “Needs are simply driven by costs as pharma

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ing machines. However, MNCs and big companies function in the global market. Not only for the sake of higher production but also to meet global regulatory norms, automated packaging machinery is the need for such companies.

“Automation is normally for higher volume and consistent business. So, it all depends on the type of products, its value and the total volume,” says Goyal.

A promising future As change is the only constant, in future, pharma packaging machinery automation is going to be the norm across the entire pharma industry, irrespective of the size of the company.

“With more and more companies looking for US FDA and cGMP accreditation, it has now become imperative to go in for automation. Even machinery suppliers like us now find that demand for automated high speed machines are more in demand, not just from the big MNC's but also small and medium scale pharma companies. Manufacturers are gradually phasing out the manual/semi automatic machines from their range and focusing more on fully automatic machines. A noted increase in import of high speed machines from Europe is also now seen.

The future therefore belongs to automation,” says Menon.

D’Souza also signs off on positive note, saying, “Automation is undergoing major evolution where robotics and mechatronic systems would be more actively used. This would enable the entire process from start to end to be controlled, monitored and supervised with minimum resources, thus providing best results in terms of productivity, quality and safety. As years go on, regulatory compliance would get stricter and this would be met only due to automation. We can guarantee a future pharma product that is 100 per cent safe for consumption, for which automation will play an important role.” sachin.jagdale@expressindia.com

(

THE MAIN FOCUS

INSIGHT

Packaging as a branding tool The pharma industry, in particular, has several functional requirements when it comes to packaging.

Dr NC Saha, Director, Indian Institute of Packaging (IIP), elaborates on how packaging has evolved over the years

DR NC SAHA, Director, Indian Institute of Packaging

P

ackaging in India has gained fillip under the ‘Make in India’ vision.

Indian brands have to become global super brands with superior packaging. Industry estimates that the global pharmaceutical packaging market will grow at a compound annual growth rate (CAGR) of 6.7 per cent from 2013 to 2018, reaching a value of $78.8 billion. In India as well, two sectors are driving the growth of the packaging industry: food and beverage and pharma.

We are an evolved market in terms of packaging today.

The term ‘packaging’ is no

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cover ) more restricted to its basic functions like containment or agglomeration, protection, preservation and presentation of consumer goods. Today, packaging plays a key role in marketing by developing shelfappeal. It also provides product information such as ingredients, storage conditions, manufacturing and expiry date, batch with lot number, gross and net weight, MRP and more importantly, helps establish the brand image of consumer goods.

Evolution of brand-packaging in pharma: anticounterfeit measures Packaging and branding are complimentary to each other because brand identification is possible only through packaging. The brand name is printed on the outer surface of a package and the packaged goods are saleable only through good branding.

The pharma industry, in particular has several functional requirements when it comes to packaging. Other than the obvious need to make attractive OTC products like protein powders and vitamin pills, that people buy with or without a prescription, there are important functions that packaging has to do.

Also, in the mind of the consumer, a good pharma brand should be able to protect itself with smart packaging that has anti-counterfeit measures built in.

Some of the examples are mentioned below: ◗ New packaging technologies attracting interest have been developed to prevent counterfeiting of drug products. Tamper-evident packaging systems include specially designed film wrappers, shrink seals and bands, caps that must be broken to access an internal seal, and sealed tubes that require puncturing. ◗ For parenteral formulations, with two-in-one prefilled vials, which have the water and active ingredient in separate chambers designed to allow

20 EXPRESS PHARMA October 16-31, 2015

select niche products.

Packaging and branding are complimentary to each other because brand identification is possible only through packaging. The brand name is printed on the outer surface of a package and the packaged goods are saleable only through good branding

mixing prior to use, it’s easy to detect tampering. ◗ Some companies may use hidden features on labels, such as fluorescing fibres or chemical reagents as encrypted text visible only under special light, while others choose to use watermarks or metallic threads as an optically variable device with images that flip or transition.

Radio frequency identification (RFID) tags are also used to track drug products. ◗ Functional security labels are also finding increasing use, including holographic labels, specially cut paper labels that only tear off, labels made of cellulose acetate or vinyl films that fragment when removed, and self-adhesive labels that, when removed, exhibit the word VOID (or another word) in the adhesive and the removed film. ◗ New ink jet coding, laser coding, and metal electrolytic etching technologies are also being employed as anti-counterfeiting measures because they enable rapid, flexible, online coding at reasonable cost, particularly due to the use of digital printing techniques. ◗ Colour-shifting inks (formulated with special pigments) that appear to change colour with the viewing angle are increasingly being used in security seals due to the ability to control the details of the colour change. ◗ Pharma packaging companies also offer anti-counterfeiting technologies based on forensic markers, such as trace chemicals and biological

compounds that can only be detected when using specially designed test kits or in the laboratory.

Better branding requires better packaging technology Global innovations in packaging are routinely shared at our biennial conference, Indiapack that hosts 300 exhibitors from over 30 countries. We showcase state-of-the-art packaging machinery, materials, services and packaging solutions to the brand owners.

International best practices are also showcased; so as to give impetus to the ‘make in India’ campaign.

Rahul Bhargav of Ranbaxy is our alumnus. Dr Reddy’s Laboratories, Biocon, Dabur and other pharma companies are regulars at our events, and most of the packaging professionals in the industry are our alumni. Industry engagement and learning is a critical part of packaging among brands.

Recognise excellence in packaging for branding Every year, IIP organises the IndiaStar awards that recognise excellence in packaging.

The winners of the India Star compete at the Asia Star awards against the best packaging trends in Asia. Similarly, the winners at the Asia Star, go on to compete at the World Star awards against the best in the world.

Our winners, over the years have been 3M, Britannia, Castrol, CavinCare, Bio-

con, Dabur, Cipla, Dr Reddy's Laboratories, Emami, ITC, JK Helene Curtis, Larsen Toubro, Mondelez India, Nestle, Himalaya Drug Company, Zydus etc. The active participation of these brands, makes me understand the importance they give to packaging.

Packaging as enabler Packaging is no longer selected in the last stages of drug development and commercialisation. A recognition that the appropriate choice of packaging can impact not only the marketability of a drug, but also aid in theft-prevention and patient compliance, has led to the consideration of packaging as an integral component of final formulated biotherapeutics.

At the same time, advances in packaging technologies are creating opportunities for greater product differentiation and better management of products across the value chain.

It should be noted that this value includes drug delivery systems that are also considered to be product packaging.

Specifically for biopharmaceuticals, the fastest growing packaging types are prefillable syringes and parenteral vials, which are required to meet the packaging and delivery needs of new biologic drugs that must be injected.

Other areas of the pharma packaging market seeing the greatest growth include labels and accessories, blister packs, temperature-controlled medicines packaging, and

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Packaging as differentiator While so far, we have been talking about tangible packaging, I must use this opportunity to bring out one of the most well-packaged, well-differentiated experiences of our time.

A stellar case study for product differentiation was in the early 2000s, when Google began taking over the search engine business on the Internet.

Before Google, there were a variety of options to use if you had to search for something online. While most of those search engines would give you the same, adequate results, they also all followed the same presentation, which at the time was pretty much just a list of web pages among some busy advertisements, news links, and images.

Google's differentiation strategy was twofold. First, simplicity. Google was minimalistic. When you went to Google.com, you saw two things: the name 'Google' and a box where you could type your search term. Users loved the design of it. The second differentiation was the algorithm used to find the results that would be returned to the user. This would come to be a very important differentiation, but one that the end user wasn't always aware existed.

So we can learn from unrelated industries as well.

Packaging for brand differentiation is everywhere. In every industry, IIP knows that packaging can make people talk about you; give your product conversation value.

Current projects on packaging for branding We work with APEDA, MPEDA and commodity boards on various projects to improve the packaging of their produce, both functionally and aesthetically.

Some of IIP’s best work has been with

( ◗ Bhuttico: Since 1944, Bhuttico has been keeping alive the Himalayan traditions in step with the latest trends in shawls. In 1993-94 Bhuttico proved itself the best in the business of handloom shawls by winning the National Award (GOLD) from the Ministry of Textiles, Government of India. A group of 12 weavers from Bhutti village came together in the year 1944 and established a cooperative society known as the Bhutti Weavers Cooperative Society. We have helped them with attractive packaging solutions to market their products. ◗ Nalen Gud packaging for Biswa Bangla: As a step towards offering its celebrated culinary heritage, the Department of MSME and Textiles, West Bengal, approached the IIP to improve the shelf life ofBengals best kept secret- liquid nolen gur (jaggery) –that goes intotheir proprietary delicacy, sandesh, a statement issued said. These shelf-life studies of liquid jaggery in packaged form are now concluded and the final packaging is being deliberated.

aging Congress, which happened in October 2015, three parallel conferences on product packaging were hosted.

They were ◗ Packaging of agro commodi-

ties, pharmaceutical and consumer products, industrial products. ◗ Flexible packaging, rigid packaging, ancillary materials, automation and logistics.

THE MAIN FOCUS

◗ Packaging research conclave exclusively for the researchers to deliver a talk on the abstracts of different research topics related to packaging.

It is now proven beyond doubt that packaging is an intergral part of branding. We are working towards enhancing the industry's understanding of the same.

Packaging as a branding tool: Industry impetus Packaging consumption in India has grown 100 per cent in the last decade, with the per capita consumption of packaging in India, now at 8.6 kg per person per year. However, continuous development and growth is critical, so that packaging can develop further. Especially since the new consumer, is ordering products at home, and experiencing the brand at home, thanks to e-commerce, packaging has become even more important.

Any industry needs impetus in terms of ◗ Technology ◗ Recognition ◗ Platform to voice concerns ◗ Education ◗ Policy support and impetus.

Through our many programmes round the year, we endeavour to do this.

For eg, at the World Pack-

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www.merckmillipore.com

MANAGEMENT I N T E R V I E W

‘There is a newer form of racial discrimination in the medical profession’ National Integrated Medical Association (NIMA) works towards strengthening the medical education of Ayurveda, Siddha and Unani doctors. It is involved in public health activities like pulse polio, tuberculosis, Beti Bachao Andolan etc and is being funded by AYUSH. Mandar Ranade, National spokesperson, NIMA, talks more in his interview with Shalini Gupta How many ASU practitioners are there pan-India and state-wise?

There are six lakh practitioners of Ayurveda, Siddha and Unani (ASU) across India, 80,000 are in the Maharashtra itself. There are practically no Siddha practitioners, except in Tamil Nadu. The number of practitioners is increasing because earlier there were only government colleges, but now a lot of private colleges are also coming up in states like Maharashtra and Karnataka.

Out of 242 ASU colleges in India, these two states boast half of the number of colleges combined together with 100 colleges in Karnataka alone and 62 in Maharashtra.

Has the number of doctors been increasing?

Since 1965, the Maharashtra government has given permission to ASU doctors to practice allopathy. Most of them are working in the PHCs in rural health, in school health as well as in NRHM. The 108 ambulance service was awarded by the Central Ministry and is practically run by the 3400 ASU doctors who are reaching upto remote areas such as Gadchiroli. Doctors who are practising pure Ayurveda is increasing and we see meritorious students actually taking up pure Ayurveda and there are a lot of opportunities for Ayurvedic practitioners abroad.

How does Maharashtra rank as far as the role of ASU

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doctors is concerned?

The national census control programme had submitted a report last year according to which wherever ASU practitioners are being utilised towards health, those states show good standards of health in terms of child mortality, maternal mortality, hygiene etc.

In states where ASU doctors are banned from practicing allopathy, like Kerala, Orissa, UP and the North East, health standards are not at par. In Maharashtra itself, 2,75,000 lives were saved by these 3400 ASU doctors doing deliveries, treating and mediating organo phosphorus poisoning and handling critical emergencies such as cardiac arrest too. This has been a huge support to the Government of Maharashtra.

The hard work of these doctors in the family planning programme has been lauded, with the Government of Maharashtra being awarded annually. In the school health mission, our doctors are going to inaccessible places where there is no transport and telecommunication. Last year the doctors reported 1000 new cases of cardiac anomalies in school going students, which would have been ignored had they not paid attention. What is commendable is that 500 of these students were operated upon in government hospitals.

So, it is for sure that these doctors are making vital contributions towards public health which in turn is being lauded and appreciated by the government. Practically, all

ICUs in metros and cities are manned by our doctors and I believe that if other states too have similar legal arrangements like Maharashtra, then definitely we can overcome the shortage of doctors and measure upto the WHO required ratio of doctors.

What is your take on the opposition from allopathy practitioners to the AYUSH system?

Pandit Nehru, in his speech on Sampoorna Swarajya, had promised integrated medicine i.e one medicine stream in India. So, we are pursuing that.

However, our policy makers, in due course, have forgotten.

China has only one MBBS course which teaches Chinese medicine as well, so if someone wants to specialise in Chinese medicine, he becomes a PG. So, a Chinese medicine doctor is an MBBS doctor. Hence, there is no discrimination vis-à-vis MBBS doctors. We always oppose the compartmentalisation of

education. This is a newer form of racial discrimination in the medical profession, with one stream claiming its superiority over another. It should not be like this. No system of medicine is complete. If the patient has a right to avail of different streams of medicine, a doctor also needs to be well-versed in all these streams. All doctors should be on one platform, I believe. A new policy is now being chalked out and there could be one course which would be beneficial for the people of India.

whereas the starting salary of MBBS doctors is ` 40,000 to 60,000. This is the discrimination that ASU doctors have to face if they go for further training or else they have to do it free of charge, they aren’t paid. Under the 108 service, they are getting 10 days of training on practically managing emergency situations, there are courses in Ruby Hall and Deenanath Mangeshkar Hospital in Pune under PGDEMS. There should be no bar on who wants to take the training.

Is modern medicine more effective than alternative medicine?

There are certain areas where modern medicine is more effective such as critical care, cardiac emergencies, poisoning etc. However, there are certain chronic diseases like skin diseases, neurological disorders, gynaecological problems where alternative medicine works well. So, a doctor needs to be well versed in both to provide the best care to the patient who has a right to get benefitted.

How can ASU be integrated into the public health system?

We have given our recommendations to the health ministry in view of the upcoming National Health Policy, including AYUSH ministry at every state level, AYUSH PHCs and AYUSH pure hospitals. With National AYUSH mission also new opportunities will open up. The policy makers need to open their prejudiced minds and make a policy where practitioners of different systems can be properly integrated. With opposition from IMA and other such bodies, some hurdles prevail.

Union Health minister JP Nadda, in a conference recently, said that IMA will have to come forward and take the process of integration ahead. So , I am hopeful that there are good times ahead for ASU practioners.

What are the difficulties faced by ASU doctors?

Inferiority in getting the training is a major challenge.

Any MBBS doctor, if he wants to pursue specialisation in any stream say dialysis, laparoscopy, etc, has opportunities and a good stipend. The ASU doctors working for 108 ambulance are working for ` 13,000 per month,

shalini.g @expressindia.com

INSIGHT

CompulsoryLicensing: Is it a non-starter or a failure of the nation?

Milind Sathe, Author, Compulsory Licensing in Knowledge Economy, in this article, elucidates on aspects of CL that are globally relevant THERE ARE few examples of compulsory licensing (CL) around the globe.

Many nations have made some or the other provisions, but interestingly these are seldom used. CL can provide a potential solution to many problems. Some nations are yet to succeed in ensuring adequate medical and healthcare support to their population. Sectors of vital importance are monopolised by foreign entities and patents are not worked. There is an exodus of national wealth. One of the major contributing factor is ignorance of CL provisions as per the law of the land. As the topic is not litigated frequently, there are fundamental queries regarding the interpretation. Promising provisions that can lift and revive economy and industry are gathering dust. There is a need to dissect the legal provisions. A vibrant global debate is required. Why, what, when has to be discussed on multiple forums.

MILIND SATHE, Author, Compulsory Licensing in Knowledge Economy

bodies dealing with IP laws and the administrative abilities of the industrial houses of the nation.

Public demand for effective use of CL provisions or its absence is an indicator of the awareness of the population about IP laws and its possible misuse or abuse by monopolists. It indicates that the population is still backward, not concerned about intellectual colonisation and hence a perfect prey for intellectual slavery.

Why CL?

Prerequisites for effective use of CL provisions

Besides its socially useful aspects, CL is also a potent strategy for revival of economy and industrial operations. CL is means to demonstrate that there exists a live and vibrant sovereign. Effective use of CL manifests that the population of nation lives in a knowledge economy. It reveals that the domestic laws of a nation are not mere paper achievements but IP offices in the nation and the population is concerned about the nation and does not tolerate misuse or abuse of the law.

It guards social aspects that are covered by relevant sections of The patents Act of the nation e.g. Sections 83, 84, 89, 91 and 92 in case of India. Industrial aspects which reveal the awareness of the industry speak about orientation towards the nation and the globe, consumer orientation and concern about the economy of the nation.

Administrative aspects reveal the readiness or willingness of the sovereign

There should be well defined legal provisions that would instil clarity as to when CL can be invoked. These provisions should enable quick invoking of CL. These should stipulate durations which will not dilute the spirit of emergency. If a particular situation is a national emergency or in circumstances of extreme urgency it should not be allowed to be decided over a period exceeding a month.

Time and rival nations or intellectual invaders are not concerned about nation’s inability or impotent provisions. Laws of the nation are designed to protect the interests of its population. Ambiguity and longer durations of processing the CL is not beneficial for the subject population. It is beneficial to intellectual invaders which are ruthless. Intellectual invaders are a modern form of colonisers looking to exploit nations and their economy. Exhibiting a lethargic or unconcerned approach to CL and its use manifests political and

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MANAGEMENT administrative backwardness, a costly affair to sustain in economic invasions in knowledge economy.

Should a nation take proactive steps to decide if a patent is open for CL or should it wait for somebody to apply for CL? Why do border security forces of any nation guard their borders round the clock? Why don’t they wait for somebody to complain that there is an invasion? If a nation guards its geographical borders round the clock and does not guard its freedom to operate in intellectual and industrial plane in a knowledge economy, what should its population and industry conclude? Should its populace conclude that the apex institute of the nation still lives in the past and has not realised the invasive games of knowledge economy? Should one conclude that political and administrative inertness is a covert invitation to invite invaders to capture the nation? Should its people conclude that the apex institution is un-

aware of its intellectual sovereignty, the intangible map of its boundaries? If nations are not concerned about their intellectual area, how will they detect invasion on their sovereignty?

IP offices of the DCs and LDCs should provide conclusive details of prosecution of the concerned patent application, granted patent, its use within the period of four years from the date of application as per Paris and TRIPs provisions, other assignments if any and if these assignments are trustworthy. An assignment which is for insignificant consideration should be acquired by the nation by law as is often provided in laws of the nation dealing with tangible property to curb suspicious transactions.

Enquiry into economical and legal aspects If the patented object is not indigenously produced but imported then its import price and the price at which it is available

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to the consumer should be a matter of scrutiny. Whether the imported quantities are distributed within the nation or are exported should be another matter of scrutiny.

If the imported or locally worked compositions are exported due to the reason that there is no sale in the local market or for any other reason, is it not direct evidence that prices are unaffordable?

If the prices or revenue earned by exports is more than the earnings by sale in the native or domestic market, doesn't it mean that the patent applicant or the patentee is not conforming to the conditions of the grant if any, which might be dictated in the law of the land?

If majority of the imported quantities are not available in the local market, can it be considered as local working? If yes, why? If no, why?

Should laws of the nation spell out the criteria for local working? Should dispersing or

distributing insignificant quantities in the local market be considered as an act to defeat the purpose of the law? If yes, why?

If no, why?

Is it related to local consumption? Is it produced in an industrial area which is identified for 100 per cent export? If it is not produced in such an area, should it be labelled as local working? Has your nation signed any agreement which defines local working or provides guideline to interpret local working?

Sovereign should define local working that is beneficial to its national goals. Are mere imports which render the patented product unaffordable or unavailable be considered as local working of the patent? If yes, why? If no, why?

Legal provisions should empower IP offices to neutralise the patent when it does not conform to domestic provisions, equivalent to provisions of TRIPs or Paris convention about the period within which the patent

should be worked. Patentee should be given the liberty to prove its position for the delay after the decision. Not more than two extensions should be granted. During this extension period, freedom should be given to other industrial rivals to work the invasion. If the patentee succeeds in working the invasion, the industrial rival should be stopped from working the invention thereafter. Ability of the other industrial player to work the invasion prior to the patentee is a significant event.

The extent of reduction in price by CL applicant should not be a matter of litigation if the domestic laws have not defined any criteria for appropriateness of low price. A third CL applicant which offers still lower price should be allowed to operate as his price will be the lowest and so on. This will promote price war even in monopolised items, spread technologies and generating employment opportunities.

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RESEARCH I N T E R V I E W

‘IO125 will be in clinics in 2017’ Invictus Oncology’s IO125 molecule is predicted to be one of the most effective treatments for Triple Negative Breast Cancer (TNBC). Dr Shiladitya Sengupta, Director and Co-founder, Invictus Oncology, reveals more to Sachin Jagdale

Explain the concept of supramolecular therapeutics in oncology?

Supramolecular therapeutics are a new class of anticancer agents that are designed to ‘home’ into the tumour. This increases the efficacy of the anticancer treatment while minimising the off target toxicity. The drugs are engineered using a computational platform technology.

What are the rationale behind rising cases of breast cancers in India?

The reason for increasing cases is still not clear. It could be changing life styles to

increased exposure to different chemicals that can induce mutations. Also, the awareness is increasing hence more cancers are being diagnosed. However, it is clear that there are more cancer patients in India than in the US, and 70 per cent of mortality due to cancer globally happen in the developing countries. More people die of cancer in developing countries than due to malaria, TB and HIV added together.

IO125 is being developed to treat Triple Negative Breast Cancer (TNBC). What will be its advantages over the

offers an expanded treatment option to these patients.

How long will it take to commercialise IO125?

IO125 will be in clinics in 2017.

That is a huge value inflection point for Invictus.

drugs currently available in the market?

There are hardly any drugs available today to treat TNBC. IO125 is a new class of molecules that is showing excellent activity in TNBC and

India is a cost sensitive market. What will be the cost of IO125 once it is launched in the market?

Invictus Oncology was started in India for precisely addressing this challenge. Did we not build visionary companies that serviced the bottom of the pyramid globally with cheap drugs while being commercial successes. Our

vision is to ensure that the best treatment is always available to a patient.

How much have been invested in developing IO125 so far?

Invictus has raised a total of $4M, and is currently raising a larger round.

Do you have any other molecules in the pipeline?

Invictus is a platform technology company. We have already developed several pipeline molecules, which target major targets in cancer such as altered immune components and kinases. sachin.jagdale@expressindia.com

NEWS

Boehringer Ingelheim: Driving new respiratory treatments Boehringer Ingelheim at the recently held ERS Congress in Amsterdam presents clinical trial data of Spiolto Respimat and OFEV, which will help the company grow in the respiratory segment.

Usha Sharma reports GERMANY-BASED pharmaceutical company Boehringer Ingelheim (BI) presented clinical trial data on Spiolto Respimat (tiotropium/olodaterol) and OFEV (nintedanib) at the recently held European Respiratory Society (ERS) International Congress 2015 in Amsterdam.

26 EXPRESS PHARMA October 16-31, 2015

New data presented at ERS supported the role of Spiolto Respimat as a first line maintenance therapy and showed superiority over steroid containing therapy. The company’s new data of OFEV (nintedanib) showed slowing disease progression and safety in patients with Idiopathic

Pulmonary Fibrosis (IPF).

Allan Hillgrove, Corporate Board Division Pharma Marketing and Sales, Boehringer Ingelheim informed that this is a landmark year for BI in the respiratory segment. The company is conducting a lot of research in the respiratory area and many initiatives are

being taken to make patients’ life more healthier. Boehringer Ingelheim’s focus is not only on developing new products but also on developing devices for the respiratory segment.

Respimat was launched in 2004 and works by delivering a unique mist, requiring the patient to take a long slow

deep breath.

Professor Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, United Kingdom showcased the changing path of IPF, highlighting the need for alternative, advanced treatment methods. Richeldi shared the story of a

57-year-old patient who never smoked but was still diagnosed with IPF. While informing about the clinical trial data of OFEV, Richeldi mentioned that data from the last four clinical trials was progressive and impressive, as 70 per cent patients who smoked enrolled for the trial. He feels that this could become the only treatment method to reduce adjudicated acute IPF. “The safety and efficacy data presented for OFEV is very reassuring with regards to the long-term outcomes of treatment with OFEV and its effect on slowing the disease progression. They add further weight to the growing body of evidence in support of OFEV as an effective and manageable treatment for IPF. When managing IPF, it is important that physicians discuss with their patients what to expect from the treatment

Spiolto Respimat as a COPD maintenance therapy and the notion that steroid-containing therapies may only be required in a population of patients with more severe stages of the disease and frequent exacerbations,” said Beeh.

“These two trials further characterise the relevant benefits provided

by Spiolto Respimat compared to two commonly prescribed maintenance treatments: Spiriva Respimat and a LABA/ICS FDC. The lung function and quality of life improvements shown in these trials add to the growing body of evidence supporting the benefit of using Spiolto Respimat at the initiation of maintenance therapy for COPD,” said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine, BI. These results adds to the recently published OTEMTO 1&2 data in Respi-

New data presented at ERS supported the role of Spiolto Respimat as a first line maintenance therapy and showed superiority over steroid containing therapy and which is right for them,” said Richeldi.

He also mentioned that this is the first time that OFEV has been included in the international treatment guidelines for IPF. Prof Ronald Dahl, Dermato-venerology and Allergy Centre, Odense Research Centre for Anaphylaxis (ORCA), addressed the unmet need in systematic asthma patients. He highlighted that despite availability of current treatment, Spiriva Respimat are improved methods for asthma treatment.

Prof Dave Singh, Clinical Pharmacology and Respiratory Medicine, University of Manchester and Kai Michel Beeh, Medical Director, Respiratory Research Institute demonstrated meaningful improvement methods in COPD. He presented new data on Spiolto Respimat and how they work effectively against placebo and help improve quality of life of patients.

“ICS-containing therapies certainly have a role in the management of COPD but questions remain regarding when to use these treatments. The ENERGITO results further support the potential benefit of

ratory Medicine which show that Spiolto Respimat provide consistent improvements in lung function, breathlessness and quality of life over Spiriva Respimat (tiotropium) or placebo. The data also shows that Spiolto Respimat provide a safety profile similar to Spiriva Respimat or placebo. Incidence of adverse events (AEs) was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups.

An interim analysis of the INPULSIS-ON extension trial has confirmed the efficacy and safety of OFEV (nintedanib) previously observed in the INPULSIS trials. It confirms that OFEV has a long-term effect on slowing disease progression and a manageable side effect profile in patients with IPF. This new data is important in light of the fact that IPF is a lifethreatening and progressive disease, requiring patients to be on long-term treatment.

(The reporter was in Amsterdam on invitation from Boehringer Ingelheim) u.sharma@expressindia.com

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RESEARCH RESEARCH UPDATES

Nobel discoveries on DNArepair now fuelling cancer drug research When DNA repair mechanisms fail, they predispose people to cancer CANCER RESEARCHERS are just beginning to understand the ramifications of the fundamental discoveries behind the 2015 Nobel Prizes in Chemistry, which were awarded recently to three scientists for explaining how cells repair mistakes in DNA that occur when cells divide.

When deoxyribonucleic acid (DNA) repair mechanisms fail, they predispose people to cancer. That is especially true of individuals with mismatch repair defects, a mechanism discovered by Paul Modrich of Duke University and the Howard Hughes Medical Institute.

Modrich, Tomas Lindahl and Aziz Sancar won the prize for "mechanistic studies of DNA repair." Their work mapped how cells repair DNA to prevent damaging errors from appearing in genetic information.

Subsequent work by Dr Bert Vogelstein of the Johns Hopkins Kimmel Cancer Center and Richard Kolodner, then at Harvard Medical School and currently at the University of California, San Diego, showed mismatch repair defects are the chief cause of the most common inherited form of colorectal cancer, affecting 15 per cent of colon cancer patients.

These defects may now help predict which patients are most likely to benefit from immunotherapies, promising new drugs that enlist the immune system to fight cancers.

A small study published earlier this year in the New England Journal of Medicine showed that 92 per cent of patients with advanced colon and rectal cancers who had

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mismatch repair defects responded to Merck & Co's immunotherapy drug Keytruda. That compared to a response of 16 per cent in patients with the same cancers who did not carry the defect.

The findings could also be applicable to patients with other cancers who have the same DNA repair

defects, and possibly to those with defects in other DNA repair mechanisms as well, Vogelstein said.

"Mismatch repair defects are found not only in hereditary colorectal cancers. They are found in about two per cent of cancer patients overall," he said.

Vogelstein also said mismatch repair is a marker for response to anti-PD-1 inhibitor drugs such as Keytruda because patients with mismatch repair defects have tumors teeming with mutations - far more than cancer patients with functioning DNA repair genes.

Since the immune system is trained to recognise foreign invaders, Hopkins researchers believe immuneboosting drugs such as Keytruda or Bristol-Myers

Squibb's Opdivo, will perform better in mutationloaded tumors.

So far, the findings, while strong, are preliminary. Vogelstein said if this same strategy extends to other cancer types, "it could provide a very useful therapy for as many as one in 50 patients with cancer worldwide."

Dr Roger Perlmutter, President, Merck Research Laboratories, said "Every company that's interested in making drugs that enhance the ability of the immune system to recognise cancer is interested in exploring DNA repair mechanisms.”

"In colorectal cancer, it's unambiguous. Administration of Keytruda is much, much more effective in those people who have DNA repair mutations," he said.

The company is conducting a larger clinical trial in hopes getting FDA approval for the drug in colorectal cancers.

Keytruda is already approved in melanoma, and in some forms of advanced lung cancer.

Other drugs targeting DNA repair defects include AstraZeneca’s Lynparza, a so-called PARP inhibitor approved for women with advanced ovarian cancer associated with defective BRCA genes. The drug kills cancer cells by exploiting defects in a tumour DNA repair pathway.

In a blog post earlier this year, Francis Collins, Director, National Institutes of Health, noted that most of the original work on DNA repair mechanisms was done in bacteria, "with no expectation of medical relevance."

Vogelstein said the latest findings in cancer immunotherapies are "a beautiful demonstration of how basic science can have practical value which no one could have seen in the beginning."

Reuters

FDAputs clinical hold on Advaxis cancer drug ADVAXIS SAID the US Food and Drug Administration has put on hold the mid-stage trials of its experimental cancer drug after a patient died.

The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the FDA, the company said.

The company, however, said the patient died due to progression of cervical cancer and the drug played no role in her death. The patient was admitted with advanced form of cancer and received axalimogene filolisbac in early 2013 in an 'investigator-initiated' trial.

Asks for additional information to prove that the drug did not contribute to the patient’s death The patient was discharged but she returned to the hospital in mid-August with respiratory distress caused by the disease.

Advaxis said the FDA has asked for additional information to prove that the drug did not contribute to the patient’s death.

Axalimogene filolisbac is being tested in patients with Human Papilloma Virus-associated cancers.

Reuters

RESEARCH

SparkTherapeutics eye therapy succeeds in study Met the goals of improving vision and sensitivity to light in patients with inherited retinal dystrophies who were previously at the risk of total blindness SPARK THERAPEUTICS’ experimental gene therapy helped improve vision in patients with a type of inherited eye disorder in a late-stage study, bringing it a step closer to becoming the first gene therapy to win US approval.

Spark said its lead drug, SPK-RPE65, met the goals of improving vision and sensitivity to light in patients with inherited retinal dystrophies (IRDs) who were previously at the risk of total blindness.

SPK-RPE65 is a form of gene therapy, a treatment which aims to insert corrective genes into malfunctioning cells. The study tested the drug in 31 patients

with IRDs, a broad group of hereditary disorders affecting the retina.

While there is no currently approved treatments for IRDs, the results place Spark comfortably one step ahead of its genetherapy rivals including Applied Genetic Technologies Corp, Avalanche Biotechnologies and ReGenxbio who are also developing their own eye treatments.

Spark expects to file for marketing approval in the US in 2016. If approved, JP Morgan analysts expect it to rake in peak worldwide sales of about $600 million.

The drug, SPK-RPE65, could be worth about $65 per Spark

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Spark’s pipeline also carries experimental treatments for other conditions such as blood disorders etc

share, Cowen and Co analysts noted last week.

Elemer Piros, Analyst, Roth Capital Partners' said he expects SPK-RPE65 to cost about $100,000 per patient per year, as long as the therapy provides lasting benefit.

Glybera, developed by Dutch biotech firm UniQure NV was the Western world's first approved gene therapy, and has been cleared for reimbursement in Germany for a one-time payment of about $1 million.

Although gene therapy has been touted as a one-time cure for intractable and expensive-totreat diseases, it has been dogged by a series of disappoint-

ments and safety concerns in its more than 20 years of research.

However, investor interest in the field has grown this year, with Bluebird Bio, UniQure NV and Spark all staging successful Nasdaq debuts.

Spark's pipeline also carries experimental treatments for other conditions including blood disorders and neurodegenerative diseases.

JP Morgan analysts also backed the potential of Spark's other experimental eye therapy, SPK-CHM, which is being tested in patients with choroideremia, another type of IRD. Reuters

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RESEARCH

Bristol-Myers drug gets FDAapproval

US FDA approves Merck’s Keytruda

The first combination of two drugs will help the immune system fight cancer THE US Food and Drug Administration has approved the first combination of two drugs that help the immune system fight cancer, a therapy regimen that could cost $256,000 a year.

Bristol-Myers Squibb Co said the FDA had given the green light to combine its immuno-oncology drugs Opdivo and Yervoy to treat advanced or inoperable melanoma, the deadliest form of skin cancer, in patients who do not have a mutation of a gene called BRAF. The approval sets the scene for many more such combinations of expensive treatments currently undergoing clinical trials by numerous drugmakers at a time when the soaring cost of prescription medicines have come under intense criticism from politicians, medical societies and patient advocacy groups alike.

Merck & Co, for example, is testing its Opdivo rival, Keytruda, in combination with other cancer treatments in at least 10 studies.

The accelerated approval was based on results of a trial in which far more patients responded to the combination than to Yervoy alone, and is contingent on Bristol-Myers replicating those results in a larger ongoing phase III study.

Four doses of the combination would cost $141,000, about six per cent more than the cost of Yervoy alone.

Those who respond to the combination would continue receiving Opdivo alone, bringing the cost for a year of treatment to $256,000, a Bristol-Myers spokeswoman said.

Opdivo and Yervoy, bought separately, would

30 EXPRESS PHARMA October 16-31, 2015

Opdivo and Yervoy, bought separately, would cost about $295,000 for just under a year's treatment, according to calculations by cancer specialist Leonard Saltz cost about $295,000 for just under a year's treatment, according to calculations by cancer specialist Leonard Saltz.

The drugs block mechanisms which cancer uses to keep the immune system from attacking tumours.

Wall Street analysts forecast sales of immuno-oncology

drugs exceeding $20 billion a year by 2020.

In the trial that led to approval, 60 per cent of combination patients experienced significant tumour shrinkage, including 17 per cent who were cancer free, compared with an 11 per cent response rate for Yervoy alone.

The combination delayed worsening of the cancer for an average of 8.9 months, only four months longer than for Yervoy. Bristol does not yet have data available showing the combination helps patients live longer, likely critical to wide acceptance by doctors.

Yervoy was approved in 2011 and Opdivo in late 2014.

The two drugs had sales of $783 million in the first half of this year.

There are about 11,000 US patients with untreated advanced melanoma. Those without the BRAF gene mutation account for 55 percent to 60 per cent of cases, Bristol said.

The company is also testing the combination in kidney cancer and the far-larger lung cancer population.

Reuters

Will be beneficial for patients with the most common form of lung cancer whose tumours produce a specific biological marker THE US Food and Drug Administration has approved Merck & Co's immunotherapy, Keytruda, for patients with the most common form of lung cancer whose tumours produce a specific biological marker.

The FDA approval for Keytruda in advanced non-small cell lung cancer is for patients whose tumours express PD-L1, a protein targeted by the drug, and includes a companion diagnostic, made by a unit of Agilent Technologies, to measure those protein levels. A Merck spokeswoman said clinical trials found that 22 per cent of patients with this type of cancer had PD-L1 scores of at least 50 per cent.

"The restricted label is generally in line with expectations and is likely to broaden over time as data from additional trials support Keytruda's efficacy in a larger patient population," JP Morgan analyst Chris Schott said in a research note. “The FDA decision has the potential to transform the way that lung cancer is treated," Dr Edward Garon, Associate Clinical Professor, University of California, Los Angeles and a lead in-

vestigator on Keytruda clinical trials, said in a statement.

Merck said the price of Keytruda for health insurers and other payers is around $12,500 per month, or $150,000 a year.

Keytruda and another similar treatment from Bristol-Myers Squibb Co called Opdivo are antibodies designed to block the interaction between PD-L1 and another protein, PD-1, whose natural function is to put checks on the immune system. By blocking the interaction, the drugs aim to enable the patient's own immune system to attack the cancer.

Wall Street analysts expect cancer immunotherapies to earn combined annual sales of over $20 billion by 2020.

Bristol's Opdivo is approved by the FDA to treat melanoma as well as squamous non-small cell lung cancer, a smaller subset of the disease, but without a requirement for protein testing.

Keytruda, now approved for both squamous and non-squamous non-small cell lung cancer, is also approved to treat patients with advanced melanoma.

Reuters

PHARMA ALLY I N T E R V I E W

‘Growth in business activity initiated us to expand our activities in India’ Gattefossé group, a global provider of excipients and innovative formulation technologies for enhancing drug delivery, is celebrating its 10th anniversary in India and has recently opened a technical centre of excellence in Mumbai. Sunil Bambarkar, Managing Director, Gattefosse India, reveals the company's growth plans to Usha Sharma How much was invested in setting up the technical centre? How did you manage to arrange the funds?

We have invested `3 crores in the technical centre and was funded by our own resource of Gattefosse India (P) Ltd.

projects in lab. ◗ Internal projects: Evaluating novel innovative applications for Gattefossé excipients in various formulations ◗ Collaborative projects with academia.

Why did you decide to set up a technical centre of excellence in India? What are your expectations from it?

And how are you planning to work in line with it?

Our strategy to undertake projects with reference to commercial viability led us to fulfill our business objectives and thus achieve a good sync of our technical and business goals. Subsequently, growth in business activity initiated us to expand our activities in India which led to the establishment of our technical centre of excellence. It has been established to address formulation development needs for customer projects and in-house global technical requirements. It is a FDA approved laboratory to facilitate the use of APIs in pharma formulations. The technical centre delivers services pertaining to use of Gattefossé excipients in pharma dosage formulations and personal care formulations.

These include the following: ◗ Customer projects: Resolving the queries raised by customers regarding use of Gattefosse excipient in the formulation and undertaking

What research works did you plan to conduct in the centre? Do you have plans to scale up manpower? If yes then how many? ◗ Pharmaceutical laboratory: The laboratory consists of an area dedicated for development of solid orals, topical and rectal dosage forms. It includes the following areas: ◗ Oral solid area: This is a dedicated facility for development of solid oral dosage forms and is well equipped with all the necessary equipment for formulating the same. These include the following: ◗ Tablet compression press (ELIZA PRESS 200 Motorised with IPPC and AWC facility) ◗ Jacketed Rapid Mixer Granulator (Saizonizer mixer granulator Cap - 10 L) ◗ Octagonal blender of 5, 2 & 1 litre capacity, GMP Model ◗ Vibro sifter (VSFT – 300 Single Deck) GMP Model ◗ Co-Mill, GMP Model ◗ Hot air oven for drying the formulated granules ◗ Various IPQC equipment, namely hardness tester, disintegration time tester, tablet friability tester, electromagnetic sieve shaker

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It has been established to address formulation development needs for customer projects and in-house global technical requirements and tap densitometer ◗ Pharma demonstration area: This facility is dedicated for conducting in – house microemulsion, suppository and topical workshops and developing small scale topical and suppository formulations ◗ Personal care laboratory:

This laboratory offers formulation development for personal care projects.

Various workshops demonstrating Gattefossé’s expertise in developing cosmetic formulations and illustrating the sensorial benefits offered by our emulsifiers are conducted here. Prototypes as proof of concept are developed using Gattefossé ingredients so as to suit the native requirements of Indian customers. Texture showcase enumerating the sensorial facets of prototypes developed using Gattefossé ingredients are conducted for customers.

We also offer ready-to-use prototype formulations that are developed taking into consideration the regional psyche and needs of Indian customers. These kits include: Moisturising cost-effective kit; fairness kit; anti-ageing kit; sun care kit; emullium mellifera regional kit.

Currently, there is a team of six professionals working in the application lab. With increase in business, we can always increase the support.

How will the new facility enhance your business portfolio?

The newly opened technical centre delivers services pertaining to use of Gattefossé excipients in pharma dosage formulations and personal care formulations.

Besides pharma excipients, the company also offers

excipients for nutraceutical and veterinary segments Yes, we also offer nutraceutical and products for the veterinary segment. These are at a very nascent stage of growth.

How profitable are these two segments and how much business does the pharma sector add to the company’s balance-sheet?

The pharma segment adds up to 75 – 80 per cent and the personal care segment adds up to 20-25 per cent of the total turnover.

The company has a wide range of applications for the pharma segment mainly for oral, topical, rectal and vaginal, however, in India the rectal and vaginal segment is still at nascent stage. How do you see this as a promising business prospect?

Yes! This is a very promising segment and the pharma industry needs to focus on these segments. However, the route of administration has a mental block with Indian patients, hence it takes a significant amount of time for growth, compared to our neighbouring countries.

What business strategies did you plan for the next one year?

We will focus on oral solids and topical in the pharma segment and skin whitening and lightening products in personal care. u.sharma@expressindia.com

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PHARMA ALLY INSIGHT

Ready for a makeover: What’s trending in the global pharma logistics?

MAYANK TANEJA, Senior Analyst, The Smart Cube

Mayank Taneja, Senior Analyst, The Smart Cube, elaborates on some of the key trends shaping logistics in the global pharma industry THE WINDS of change are blowing through, and, in fact, revolutionising logistics in the global pharma industry.

The prime factors contributing to this are rising costs, growing risks, changing consumer needs and tightening regulations globally. From using data analytics to developing cold chain capabilities, pharma companies, in tandem with logistics firms, are leaving no stone unturned to tackle the mounting challenges. Since payers and consumers are likely to continue demanding effective and proficient healthcare, the part of the supply chain that handles the last mile of delivery is changing.

Outsourcing to third-party logistics providers (3PLs) “More companies are outsourcing logistics than we have seen in many years” - Joe Carlier, Senior VP – Sales, Penske Logistics (June 2015) The desire to control the entire supply chain hindered the outsourcing of logistics operations in the pharma and life sciences industry in the past. However, the benefits of outsourcing, including reduced costs and cycle times, improved customer responsiveness and shifting focus on core capabilities, are driving pharma companies to outsource parts of their overall logistics function to 3PLs. For instance, in March 2015, Germany-based pharma company STADA Arzneimittel outsourced its domestic logistics business to DHL in a bid to save costs and focus on its core activities.

32 EXPRESS PHARMA October 16-31, 2015

Buoyed by their growing importance for healthcare companies globally, 3PLs are increasing their service offerings. For instance, in October 2013, FedEx partnered with Ohio-based healthcare service provider Cardinal Health to offer premier 3PL solutions for the healthcare industry.

And it does not stop there.

Growing popularity of cold chain logistics “UPS sees the greatest demand for cold chain transportation services in Europe and the US, which are the two largest export markets for healthcare. Since 2011, we have experienced a significant increase in demand from leading biotech, pharma and medical device manufacturers alike” - Susan Li, Senior Manager, UPS Temperature True Pack aging (April 2015) “The pipeline of drugs waiting for approval over the last few years has been biologically based drugs with large molecular structures. These require temperature control” – Angelos Orfanos, President, DHL Life Sciences & Healthcare (June 2015) Due to a surge in the demand for chilled/frozen products, both pharma and nonpharma (primarily FMCG), global logistics service providers are focussing on augmenting their cold chain infrastructure. In June 2015, just a month after opening a healthcare-dedicated air freight forwarding facility at the Amsterdam Airport Schiphol, UPS, one of the world’s largest parcel delivery firms, announced that it was

According to Pharmaceutical Commerce, a US-based pharma magazine, pharma cold chain logistics will generate >$10 billion in revenue in 2015, which is expected to increase to $13 billion by 2019

building a new healthcare distribution centre in Roermond, Netherlands, to meet growing demand from the pharma sector. The facility, expected to be completed by January 2016, will provide temperature-sensitive storage, apart from services such as quality assurance and inventory management. UPS’ competitor, DHL, is also quite active in cold chain logistics.

During 2012–2014, the company invested heavily in people and facilities capable of handling temperature-sensitive shipments. As of June 2015, DHL has added 13 life sciences packing stations to its pool of 41 stations in 2014.

The rising demand from

pharma is attributed to companies focussing on complexstructured biotech drugs, which typically require strict temperature control during shipping. According to Pharmaceutical Commerce, a USbased pharma magazine, pharma cold chain logistics will generate >$10 billion in revenue in 2015, which is expected to increase to $13 billion by 2019.

Technology, technology everywhere What air is to humans, technology is to today’s business world and logistics companies are no different. From analytics to serialisation, technology is omnipresent in today’s pharma logistics landscape, and how!

Serialisation technologies: Governments across the world are enacting regulations to check the infiltration of counterfeit drugs, whose prevalence has grown considerably in the last few years.

For example, India’s Directorate General of Foreign Trade (DGFT) has mandated the use of unique numbers and barcodes, a practice known as serialisation, on primary, secondary and tertiary packaging for easy tracking of all exported drugs. The California ePedigree Law, which requires pharma manufacturers and distributors to implement serialisation, also came into effect from January 2015. Quick to react, pharma and logistics companies have started gearing up for a stricter regulatory regime.

Global pharma major Pfizer has been implementing serialisation aggressively since 2012, and helping suppliers do

the same. In June 2013, DHL launched a temperature-controlled, high-visibility air freight service, DHL Thermonet, targeted at the life sciences and healthcare industries. The solution employs ultrahigh-frequency (UHF) RFID tags with in-built temperature sensors, and allows DHL's customers to maintain a record of shipping temperatures, in addition to helping them track their shipments.

Analytics (Big Data): How could one dare underestimate the importance of the massive volumes of data being generated all around us? Over the past few years, there has been a sharp spike in the near real-time data that logistics providers collect through various sources, including sensors, smart phones and other telematics tools. This data is now being leveraged to optimise delivery schedules and even forecast, with the aid of predictive analytics, future demand, in order to maximise resource utilisation. UPS is the perfect example of a logistics company deriving benefits from analytics and telematics. The company has been using predictive analytics to plan its delivery operations since 2003, and has seen a yearly reduction of 85 million miles driven per year, reducing its fuel need and carbon emissions by 8 million gallons and ~7,700 tonnes, respectively.

Increased use of reverse logistics Consumers and retailers are increasingly returning sold and unsold goods, respectively, to manufacturers, which have started focussing

PHARMA ALLY extensively on customer satisfaction and environmental concerns. As most companies (including the pharma giants) outsource this task to 3PLs, the onus of delivering results lies with the latter.

For instance, Genco (acquired by FedEx in January 2015) offers reverse logistics services to about 80 healthcare product manufacturers, including 14 of the top 20 global healthcare companies.

The company has installed specifically designed software to manage the reverse flow of products, lowering costs and expediting the movement of returned products. Additionally, it has established warehousing facilities and implemented security services for returned pharma products.

Collaborative logistics “Eastern Europe was chosen be-

Increasing cost pressures have compelled companies in various industries, including pharma, to collaborate with peers, even direct competitors, to reduce transportation and distribution costs cause the destination points of UCB and Baxter were in the vicinity of capital cities, and because the distance from Baxter and UCB distribution centres in Belgium to the final locations was quite huge. The greater the distance, the more are saving opportunities of flow bundling” - Sven Verstrepen, Business De velopment Director, Tri-Vizor (November 2013) Increasing cost pressures have compelled companies in

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various industries, including pharma, to collaborate with peers, even direct competitors, to reduce transportation and distribution costs. The best example in the pharma industry is that of American giant Baxter’s collaboration with Belgium-based pharma manufacturer UCB. The two companies partnered in 2011 to share logistics for six Eastern European countries, including Romania and Slovakia, owing to closer destina-

tion points. The partnership was arranged by Tri-Vizor, a Belgium-based firm engaged in facilitating horizontal collaboration among organisations. It has helped the companies achieve cost savings of >15 per cent, along with a 50 per cent reduction in carbon footprint. Later, in 2012, Baxter partnered with US-based filtration product manufacturer Donaldson to cut logistics costs. During 2012–2013, the company worked with Eu-

ropean consortium Collaboration Concepts for Co-modality (CO3), a government-funded project, to demonstrate the viability of horizontal collaborations. Over the course of the project, Baxter and Kimberley-Clark witnessed 10 per cent savings on transportation through horizontal collaboration. After various instances of successful implementation, Baxter is now eyeing an opportunity to partner with consumer goods giant P&G. The impact of the trends discussed in this article is likely to be far-reaching and transformational enough to devote separate articles on each of them. A quick glance, however, prods one to consider which trend could likely be a game changer, and which would fade like a transient flash in the pan.

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PHARMA ALLY PRODUCTS

Walk in stability chamber byTempo Instruments TEMPO INSTRUMENTS has launched walk in stability chamber. The features are: ◗ Stability testing is an integral part of formulation development. It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances and products and recommended storage condition. Stability data are required to be submitted as a part of the dossier submitted to the regulatory agencies for licensing approval. ◗ Electrical and electronics industries for testing components and equipment. ◗ Testing cement, batteries, cigarettes or any other material demanding controlled temperature and humidity. ◗ Packing industries. ◗ Department of botany, cytology, plant and animal breeding.

As per ICH guidelines to control following conditions: At 25 degC : RH = 60 per cent At 30 degC : RH = 65 per cent At 40 degC : RH = 75 per cent

throw in the stability room.

In-built stand by refrigeration system with auto change over facility.

Control System Microprocessor based PLC with 4.3” HMI (touch screen colour display, which gives the direct display of process value and set value of temperature and humidity in the chamber.

High speed ethernet-based communication.

Safety features ◗ Audio visual alarms are generated for temperature / humidity variation. ◗ Incase temperature goes above 60 deg. Cutoff the dry heater, wet heater and compressor. ◗ Float switch to cutoff the wet heater supply in case of low water level in the boiler tank. It also has audio and visual alarm.

Features

Construction ◗ Double walled insulated PUF modular panels for easy assembling at site. ◗ Leak proof door with full gasket and air tight mechanical lock ensures no leakage through chamber. ◗ Observation window (30 x 45) for viewing sample inside the chamber. ◗ The unit is provides with perforated stainless steel trays. ◗ 80 mm thick best quality of polyurethane foam, CFC free and environmentally friendly are injected in to panel. ◗ Air circulation: Forced air to assured maximum uniformity of temperature and humidity inside the chamber. ◗ Heating system: High quality SS Tubular Heater (made of Nichrome wire sheathed in SS tube). Special arrangement of heaters avoids direct rendition on stored samples.

Humidity system Non-condensing type steam in-

34 EXPRESS PHARMA October 16-31, 2015

jection system with water level switch. Humidity system provided with a low pressure boiler tank and reservoir tank dully argon welded with float valve. Low water level cut off switch ensures sufficient water level in boiler tank. DM Water is preferred. In- built stand by humidity system with auto change over facility.

Refrigeration system By means of CFC Free hermitically sealed Emerson Copland make compressor for better cooling with eco-friendly refrigerant.

The cooling system is made up of split type so as one can place the compressor coupled with condenser unit in well – ventilated area and avoid hot air

◗ Negligible maintenance – The sturdy design and long–lasting finish ensures minimum maintenance for years ◗ Minimal heat transfer – The tongue and groove edges of all panels are molded to close tolerance ensuring tight fit between panels. This prevents condensation from forming on the foam and minimize heat transfer. ◗ Quality accessories – Hardware like hinges, handles etc. on panels from best indigenous / foreign suppliers. ◗ Optional features ◗ CFR 21 part 11 compliance software for PLC with RS 485 or Ethernet communication. ◗ Data scanner complete with sensor. ◗ SMS Mobile alert system. ◗ Door access security system.

Contact details Ashwin Singh Tempo Instruments Top Syringe Compound, Pandurang Wadi, Behind Samrat Hotel, WE Highway, Mira Road (E), Thane -401104

PHARMA ALLY VENDOR NEWS

Waters’Centers of Innovation Program honours Ohio State University Laboratory Wysocki-Led facility recognised for proteomics, disease research, mass spectrometry excellence THE OHIO State University and Waters Corporation officially welcomed the University’s Campus Chemical Instrument Center into the Waters Centers of Innovation Program. Headed by Prof Vicki Wysocki, an Ohio Eminent Scholar and Professor of Chemistry and Biochemistry, the centre is renowned for fundamental research into ways of characterising protein complexes, or assemblies of multiple individual proteins, that living organisms depend on for their survival.

The research of the Wysocki Research Group could one day lead to new understanding of conditions, such as high blood pressure, arteriosclerosis, pre-eclampsia, and chronic obstructive pulmonary disease, among others.

“We are honoured to join the Waters Centers of Innovation Program as a partner and applaud the state-of-theart instrumentation and technical support that Waters has provided,” said Caroline Whitacre, Vice President for Research, Ohio State.

“Having access to the Waters technology has enabled the stellar work of Wysocki as she works to develop improved mass spectrometry approaches to determine structures of protein complexes. This research is helping researchers across the Ohio State campus and elsewhere to achieve breakthroughs and develop solutions that will have global impact.”

Abetting Wysocki in her research are advances in mass spectrometry technologies that allow her to probe the structures of protein complexes like never before.

EP News Bureau-Mumbai

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Consulting: project development + feasibility studies + technical due diligence + GMP audits + licenses.

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Implementation: procurement + delivery + building and consturction supervision + commissioning.

Validation & qualification: comprehensive GMP compliance + integrated concept.

Project management.

We combine professional engineering with in-depth technology expertise. Wordwide!

You benefit from flexible and reliable engineering solutions from 'one source'.

Glatt (India) Engineering Pvt. Ltd., Plot No. 251, Okhla Industrial Estate, Phase III, New Delhi – 110020, India Tel + 91 11 40 85 85 85, info@glatt-india.com, www.glatt.com

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Contact person: Mr. Anoop Razdan - GM Projects & Head Engineering, email: anoop.razdan@glatt-india.com

Glatt. Integrated Process Solutions.

PHARMA ALLY PRODUCTS

Optima Pharma to showcase its products at China Pharm WITH ITS business fields pharmaceutical and life science, Optima, the German specialist machine engineering company provides perfect solutions for medicinal products, diagnostics and advanced wound care.

Optima Pharma will present its latest developments in filling, closing and process systems for medicinal and diagnostic products at China Pharm, to be held at SNIEC Shanghai, China from November 17 – 20, 2015.

Part of the portfolio includes containment systems for sterile processing, including isolators and pharma freeze-

nostic products. Core competences include web processing technologies and primary and secondary packaging. Combined with packaging functions, the result is automated complete lines. Optima Life Science's modular machine systems provide the customer with a unique 'plug & play' flexibility.

drying. The spectrum ranges from machines in laboratory size through to fully automated turnkey complete line solutions which are ever more in de-

mand. The multi-use principle and maximising of product yield are further leading technologies from Optima Pharma.

Optima Life Science is the

specialist for inline production and packaging of advanced wound care products as well as highly flexible manufacturing and packaging lines for diag-

Contact details OPTIMA packaging group Sabine Gauger Marketing Director +49 (0) 791 / 506-1410 sabine.gauger@optimager.com www.optima-packaginggroup.de

Dock levelers by Gandhi Automations GANDHI AUTOMATIONS is offering complete logistics solutions by providing dock levelers, dock shelters, sectional overhead doors and dock houses.

Electro-hydraulic, mechanical and air-powered dock levelers not only act as a bridge for connecting a vehicle, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This leads to minimised energy used. One can save on heating and chilling costs, which results in maintaining the quality of transported goods. Dock levelers are designed as per EN 1398 standard.

The cost of loading and unloading of goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into

36 EXPRESS PHARMA October 16-31, 2015

the process. Gandhi Automations has always designed solutions based on such scientific approach and feedback from clients. The dock levelers offered by the company ensure loading and unloading with lesser effort and minimal cost.

It is possible to load and unload the products in a safe way and in the process can save energy. The loading bay remains

with the dock leveler in rest position and the sectional overhead door remains closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers.

The sectional overhead door opens only when the vehicle is positioned, brakes are applied and engine shuts off. This

eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveler connects to the truck bed for loading/unloading to take place.

At the end of the loading/unloading, the dock leveler is put to rest and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

with automatic end-of-run, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349. b)Telescopic lip dock levelers Telescopic lip dock levelers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc. These types can be supplied with a lip extending up to 1 m.

The dock levelers are equipped with the most secure safety devices and accessories.

Following are the two types of dock levelers

Contact details Gandhi Automations 2nd Floor, Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, Off :+91 22 66720200 / 66720300 Fax: +91 22 66720201 Email: sales@geapl.co.in

a)Radius lip dock levelers Radius lip dock levelers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc.

The self-cleaning lip hinging system does not retain rubbish

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PHARMA LIFE APPOINTMENT

Dr Bhaskar Chaudhuri and Alan Rosling join Vyome Biosciences’board of directors Chaudhuri is the operating partner of Frazier Healthcare Ventures and Rosling is the senior advisor at Navam Capital VYOME BIOSCIENCES, a clinical stage dermatology based biopharmaceutical company, has appointed Dr Bhaskar Chaudhuri and Alan Rosling to its Board of Directors.

Reportedly, Chaudhuri has more than 25 years of experience with leading biopharma companies in leadership, strategy and management, drug research and development, and commercialisation in the US, EU and emerging markets. He has led the development and FDA approval of multiple New Drug Applications (NDAs).

Chaudhuri served as the President and Chief Executive Officer of Dow Pharmaceuticals for

seven years, leading up to their acquisition by Valeant Pharmaceuticals. After acquisition, Chaudhuri served as the President of Valeant Pharmaceuticals International from January 2009 till September 2010.

He is currently an Operating Partner of Frazier Healthcare Ventures. Chaudhuri has a doctorate in physical pharmacy.

“As Vyome scales up multiple drug development programmes, enters clinical trials and accelerates the commercialisation phase, Chaudhuri will add tremendous strategic experience to the Board. His vast experience in commercialising novel dermatology drugs, and leadership with top-tier

Chaudhuri is known as a business strategist while Rosling offers strong global business experience pharma companies will brings significant value to Vyome,” said Venkateswarlu Nelabhotla, Co-founder and Chief Executive Officer, Vyome

Biosciences.

“Vyome is a proving to be a highly credible innovative player in the life sciences industry, with novel platforms and drug development programmes, and I am delighted to be a part of the company’s illustrious Board of Directors.

Vyome’s current portfolio of innovative and breakthrough products provides a strong foundation for the company to emerge as a global leader in its field,” Dr Chaudhuri added.

Alan Rosling is the senior advisor at Navam Capital.

Rosling co-founded Kiran Energy in 2010 and was the Executive Director of Tata Sons and Chairman of the Jardine Math-

eson Group in India.

“I am delighted that Chaudhuri is getting involved with Vyome at this crucial stage of commercialisation. He has a stellar reputation as a business strategist, and his extensive experience in the biopharma industry will be a valuable asset for the company. Alan Rosling brings strong global business experience to the Board, and he will be a tremendous resource for the company as it continues to go from strength to strength in the coming years,” commented Dr Raghunath Mashelkar, Chairman of Vyome’s Board of Directors.

EP News Bureau-Mumbai

CAMPUS BEAT

Smriti College of Pharmaceutical Education, Indore conducts workshop on HPLC Delegates from across Indore participated from Indore SMRITI COLLEGE of Pharmaceutical Education, Indore recently organised a workshop on HPLC. Delegates from across Indore participated in the workshop. Dr Sanjay Jain, Director of Smriti College of Pharmaceutical Education, welcomed the Chief guest Dr SK Jain, Professor- Department of Pharmaceutics, Sagar University, and all the delegates. The technical session

56 EXPRESS PHARMA October 16-31, 2015

was headed by Dr AG Hariharan and Sudhakar CK, who spoke about the basic techniques used in HPLC and briefed about software used for the functioning of HPLC. The technical session was followed by a practical exposure of HPLC under the guidance of Jacky Dumbwani and Ankit Mangal.

In the valedictory session, convener of the workshop,

Sumeet Prachand distributed certificate of participation to all

the delegates and Rakesh Barik. coordinator of the workshop,

conveyed the vote of thanks.

EP News Bureau-Mumbai

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

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