Express Pharma (Vol.11, No.8) February 16-29, 2016

VOL. 11 NO. 8 PAGES 62

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Market ‘India has a great potential to become a major player in the bio-pharma innovation process’ 16-29 FEBRUARY 2016,` 40

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CONTENTS MARKET Vol.11 No.8 FEBRUARY 16-29, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka

Pharma MSMEs will miss the Make in India bus unless they upgrade to global norms. But industry stalwarts point out that the government needs to do more to help them move up to the next level | P16 P22: INSIGHT The age of Prodices

Senior Designer Rekha Bisht 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 Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P28: INTERVIEW ‘Our recent initiative is an effort to provide innovative and cutting-edge technology to our customers’

PHARMA ALLY

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SCHOTT SEES SALES AND ANNUAL RESULTS CLIMB

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WATERS INTRODUCES CORTECS C8 AND PHENYL 1.6 AND 2.7 MICRON COLUMNS

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P29: INTERVIEW ‘Our focus is mid and large Indian companies’

P55: INSIGHT The leadership gap

PHENOMENEX EXPANDS CHIRAL SCREENING AND SEPARATION POWER WITH NEW LUX 3μM AMYLOSE1 CHIRAL COLUMNS

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NEELIKON ADDS ICP – OES TO CHECK METALLIC IMPURITIES

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FORMULATION CHARACTERISATION THROUGH PARTICLE SIZING AND RHEOLOGY

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‘INDIA HAS A GREAT POTENTIAL TO BECOME A MAJOR PLAYER IN THE BIO-PHARMA INNOVATION PROCESS’

RESEARCH

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PFIZER, J&J, MERCK EVALUATING TECHNOLOGIES FOR ZIKA VACCINE

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BEARD BACTERIA COULD LEAD TO NEW ANTIBIOTICS

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TENDON PAIN LINKED TO TYPE II DIABETES

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

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

EDITOR’S NOTE

Revival mantras for MSMEs

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recious things come in small packages (think diamonds). But this logic doesn’t seem to hold for Micro Small and Medium Entreprises (MSMEs). Even though the sector received a salute from the Centre, from none other than the Minister of State for Commerce and Industry Nirmala Sitharaman. Giving away the CHEMEXCIL awards, the minister acknowledged that SMEs would play a vital role in the growth of exports of chemicals.

While the CHEMEXCIL awards span basic chemicals, dyes and cosmetics, her pronouncement should logically hold true for pharma SMEs. Why then do pharma MSMEs feel that they are not getting their fair due?

It is true that key announcements like the API policy are yet to see the light of day. But it is equally true that many MSMEs still resist upgrading their systems and processes, tagging technology updates as a cost rather than an investment.

There is some truth in both sides of the argument. As various experts rightly point out in our latest cover story (February 16-28, 2016: ‘In need of renewed focus'), several mid to small size pharma players could end up missing the 'Make in India' bus if both sides do not refocus their energies in the right direction. Further delay could have long-term repercussions on the industry as a whole.

In fact, the ‘Make in India’ initiative is not a new mantra for the pharma sector. Mid and small sized units have been the main sourcing partners of large companies. The supply of high quality ingredients at competitive prices has been the hallmark of the Indian API industry, which in turn allowed their clients to sell formulations at competitive prices across the world.

But today, most API manufacturers find that they are unable to compete with nations like China who are able to undercut them on prices of many ingredients, thanks to the sops they receive from their governments.

Pharma MSMEs thus find themselves cornered on many fronts. As SR Vaidya, who chairs IDMA's SME Committee puts it, with price control on one hand and more stringent norms, it is a tight rope walk to satisfy the government, regulators as well as consumers/patients.

The first concern is that even if MSMEs are open to upgrades, the rate of technology

Several mid to small size pharma players could end up missing the ‘Make in India’ bus if they do not refocus their energies in the right direction

obsolescence has shrunk from one decade to five years. As Bhavin Mehta, Director, Kilitch Drugs points out, they now find themselves in a never ending race to upgrade and stay ahead of competitors from neighbouring countries.

Secondly, regulators in India too are setting higher standards. For instance, as former Deputy Drug Controller (India) Dr D Roy analyses, the proposed revision of Schedule M of India's Drug & Cosmetics Rules intends to bring it more in line with WHO GMP norms by closing the many gaps that exist in its current form.

And thirdly, the span of drug price control is expanding. This triple whammy of increasing capital expenditure, higher regulatory benchmarks and decreasing margins could see many MSMEs bite the dust, warn industry insiders.

But MSMEs with strategic vision will see opportunities in these challenges. For instance, upgrading to WHO GMP norms will definitely entail upfront initial expenses of training personnel, putting in place the necessary equipment but Roy reasons that the long-term benefits of putting in place a more ‘transparent and unambiguous’ GMP system are far greater.

Training of staff to understand the nuances of new GMP norms too will pay off rich dividends in the long run. Industry associations have been trying to nudge their members, encouraging them to see the bigger picture.

For instance, SV Veeramani, President, IDMA reasons that upgrading to WHO GMP standards, would open up more export markets as well as make them more attractive contract manufacturing partners for both Indian as well as global pharma MNCs. But the government must play a more active role. Both Veeramani and Viranchi Shah, Vice Chairman of IDMA's Gujarat Chapter, underline the need for soft loan schemes to support technology upgrades as well as preference in government procurement tenders which would help set off the cost of upgrades.

Besides upgrading the hardware, the ‘human ware’ too is in dire need of upgrades. The talent pool in the pharma sector is far from being as deep or wide as desired and this could well turn out to be the biggest stumbling block.

Will the upcoming budget bring cheer to the pharma MSME sector? And beyond the budget do both sides have any choice but to find common ground?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

10 EXPRESS PHARMA February 16-29,2016

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‘India has a great potential to become a major player in the bio-pharma innovation process’ Recently, Professor Meir Pugatch, IPKM Chair University of Maastricht, Professor Frank Lichtenberg from Columbia University and Mike May from Scientific American Worldview presented their empirical studies at the USIBC Convenes Conference.

Raelene Kambli speaks to Pugatch, Lichtenberg and May, on how India can become a global leader in the R&D and biopharmaceutical sector while also expanding healthcare access in country

What scope do you see for the Indian life sciences and bio-pharmaceutical sector on the global front?

Professor Meir Perez Pugatch – India holds an outstanding potential to become a regional leader in the field of life-sciences and biopharma innovation, especially given the greater government support for biomedical investment and innovation under the Modi administration. The future success of government initiatives such as the 'National Biotechnology Development Strategy' could boost India’s capabilities to compete in new fields of biopharma innovation.

Yet at the same time significant gaps, which have historically represented a major challenge to innovators seeking to operate in India, should be addressed. For example, looking at the findings of recent Pugatch Consilium research, these gaps and challenges exist in several areas such as India’s IP regime, its clinical research policy environment and regulatory framework. The

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Modi administration has already shifted its attention to some of these issues. By addressing these aspects and bringing them to the acceptable level of global international standards, India stands to meet its aforementioned potential and benefit greatly from it.

Certain regulatory barriers can also negatively affect access to healthcare

While global markets ‘ slow-down’ slight decrease FDI inflows may take place

MIKE MAY Editorial Director, Scientific American Worldview

PROFESSOR MEIR PUGATCH IPKM Chair University, Maastricht

You say that India can become a global top-10 competitor in the life sciences and bio-pharma sector. Can you explain how?

Professor Meir Perez Pugatch – India has a great potential to become a major player in the global pharma arena, not only in the generic front but also in the biopharma innovation process.

Indeed, the recent Biopharmaceutical Investment & Competitiveness (BCI) Survey of 2015, which gauges these ecosystems in a sample of countries, shows that India currently performs well in several areas, not least with regards to its infrastructure and scientific level of research.

Yet at the same time the BCI survey also identified four

areas of weakness which India should address: 1) regulatory deficiencies and bottlenecks in the approval and review process on innovative products; 2) limited coverage of medicines even with costs driven down; 3) a relatively weak biopharma IP protection, and 4) insufficient collaboration and outputs between public research bodies and private enterprises.

I believe that once India addresses these gaps it will become a much more attractive hub for investment and innovation in 10 years’ time.

How can innovation in the bio-pharma sector help in increasing healthcare access in India?

Mike May - In some cases, innovative medicines require less complicated storage methods and easier delivery methods, such as pills versus injections, and this could take healthcare to more remote areas.

Professor Meir Perez Pugatch – One such prominent way is through clinical research. Pugatch

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Consilium’s Scaling Global Clinical Trial Activity of 2014 finds that clinical trials provide patients with access to innovative drugs, which may literally revolutionise existing treatments, and often continue beyond the duration of the trial. Clinical trials also provide physicians with experience in cutting-edge and skills, and often involve improvements to infrastructure and health technologies in local communities. Additionally, with costs of the drug itself and associated tests often being borne by the study’s sponsor, clinical trials may lead to savings for healthcare systems, in some cases, the sponsor may continue to provide the treatment at a preferential price.

Conversely, certain regulatory barriers in terms of innovation can also negatively affect access to healthcare. For example, the lack of Regulatory Data Protection for submitted clinical test data, excessive patentability requirements and gaps in predictability and transparency in the criteria and processes governing clinical research outlined in the Drugs and Cosmetics Act all play some part in India’s currently extremely low clinical trial activity and total number of new drug launches.

Tell us about the Scientific American Worldview's seven years of meta-analysis finds?

Mike May - From 2012-2013, India's data produced stable outcomes, and then it improved slightly from 2014 to 2015. All BRIC countries, however, need to improve considerably to compete with the current world leaders in innovative biotechnology.

According to your study what's in store for India?

Professor Frank Lichtenberg – India has made impressive strides in the past 50 years. In 1960, life expectancy at birth in India was 30 years lower than it was in the US (40 vs. 70).

Today, it is about 13 years

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lower (66 vs. 79). Thus, India has closed more than half of the life expectancy gap between it and the US.. Much of the progress was probably due to the implementation of basic public health measures: better sanitation, environmental regulation, increased childhood vaccination rates, etc. The evidence suggests that to make further substantial progress in population health, the quality of healthcare goods and services must continue to improve. My research has demonstrated that use of new medicines can play an important role in improving the quality of health care, because the quality and efficacy of new medicines tend to be significantly higher than that of older medicines.

Indian policymakers should therefore focus their efforts on ensuring that the Indian people have access to recently developed drugs, medical devices, and procedures.

Professor Meir Perez Pugatch – One of our recent researches: Quantifying the Economic Gains of Strengthening India’s Clinical Research Policy Environment has found that by improving its clinical research policy environment to roughly the median level of international best practices, India could increase the number of new clinical trials per year to above 800 and add over ` 600 million in direct monetary transfers and indirect economic gains, with more than 50 per cent of which directed at hospitals, related services and patients.

Indian policymakers should ensure that the people have access to recently developed drugs, medical devices, and procedures FRANK LICHTENBERG Columbia University

This may be regarded as a conservative estimate. It is possible India could experience even higher levels of investment and economic gains.

What kind of investment is required by India to foster innovation in life sciences?

Professor Meir Perez

Pugatch – Essentially, the life sciences and biopharma sector relies equally on public and private investments. India, under the Modi administration, has pushed several government initiatives and policy reforms focused on the life sciences sector which may prove very useful in improving its output.

Looking at the analysis of India’s biopharma ecosystem in the Biopharmaceutical Investment & Competitiveness (BCI) Survey of 2015, the major areas of investment, crucial to foster innovation in India, are its IP regime which suffers from overall ineffectiveness. .

With the global markets slowing down currently, do you think that this phenomenon would negatively impact research related to life sciences and the bio-pharmaceutical sector globally?

Mike May - Data in Scientific American Worldview indicate an increase in market capitalisation for public biotechnology companies in many countries over the past two years, and that should actually drive more research.

Professor Meir Perez Pugatch – Naturally, some impact as a ripple-effect can be expected, though to minimal extent. The life sciences and biopharma sector is of the most innovative sectors across all industries, with some 15 per cent of revenues invested in future R&D according to some estimates. While global markets ‘slow-down’ slight decrease FDI inflows and

The recent Biopharmaceutical Investment & Competitiveness (BCI) Survey of 2015, which gauges these ecosystems in a sample of countries, shows that India currently performs well in several areas, not least with regards to its infrastructure and scientific level of research

some shifting and reordering of strategies may take place, history suggests that this sector is less sensitive and vulnerable to market trends.

Give us five trends that the world should look for in 2016 where life sciences and the bio-pharma sector is concerned?

Professor Meir Perez Pugatch Biosimilars: With the impending patent loss of a growing number of biological drugs, the need to address the many issues of biosimilars – e.g. naming, interchange ability, quality assurance and many more – become more pressing. Of equal importance is generic manufacturers’ ability to manufacture biosimilars while maintaining all their properties, a requirement which necessitate much more stringent requirements and modern equipment.

Potential shift in the P&R schemes : The high cost of some innovative treatments had elevated discussions regarding the current pricing and reimbursement schemes, and the potential of new directions which are based on risk-sharing and pay-foroutcome schemes.

Strengthened dialogue between industry and regulators : There is a growing recognition within drug manufacturers and drug regulators alike of the benefits in engaging in collaborative discussions, which may develop into a new, more productive ‘partnership’ between drug regulators and drug manufacturers which maintain international standards.

Healthy ageing : Innovative treatments targeting elderlyspecific diseases such as Alzheimer and dementia have long been in the pipeline, yet failure rate was high. As around the world population is rapidly ageing, more effort is directed toward this field, with some result possible in the near future. raelene.kambli@expressindia.com

EVENT BRIEF FEBUARY 2016 - APRIL 2016 17

DigiSights 2016

DIGISIGHTS 2016 Date: February 17, 2016 Venue: Manik Sabhagriha Auditorium, 791, Indian Education Society, SK Marg, Bandra Reclamation, Bandra West, Mumbai Summary: MediaMedic Communications along with its global partners from GLOBALHealthPR group will present DigiSights 2016.

'DigiSights 2016,' an exclusive 'Digital Marketing Conference for pharma and healthcare.

This will be the third consecutive year in which this programme is organised for pharma and healthcare marketers. Organised in association with IES Management College & Research Center, this year DigiSights 2016 will showcase some international pharma case-studies along with local success stories. The theme for the forthcoming program is ‘Global Learnings, Local insights'.

Contact details Website: http://mediamedichealth.com/ digisights2016/index.html

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

Contact details PHARMA Pro&Pack Expo 2016 / Mumbai

EXPRESS PHARMA

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February 16-29,2016

27 GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E:mail@PharmaProPack.com W: www.PharmaProPack.com

PHARMA Pro&Pack Expo 2016 2ND EDITION OFASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a

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premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotechnology, research and testing instruments and consumables. The exhibition will be organised by Fenza Ex-

2nd Edition of Asia Labex hibitons.

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

cover )

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SV VEERRAMANI President, IDMA

'INDUSTRY NEEDS FINANCIAL ASSISTANCE FROM THE GOVERNMENT'

I Pharma MSMEs will miss the Make in India bus unless they upgrade to global norms.

But industry stalwarts point out that the government needs to do more to help them move up to the next level

BY USHA SHARMA

To subscribe: bpd.subscription@expressindia.com

n India, pharma SMEs have been started by several entrepreneurs with either pharmacy background or experience in pharma industry. It reflects their entrepreneurial spirit and creative urge to achieve something credible in the Indian pharma industry.

Several SMEs in the past are now large companies with international presence.

Pharma SMEs in India are continuously growing at different levels and they can take us to a bright future of the Indian pharma industry. Hence, it is very important that adequate support and nurturing of SMEs should take place to safeguard the future of the sector.

Pharma SMEs require support for the following: ◗ Technology upgradation: SMEs require technology upgradation fund to upgrade their plants and meet the increasing global requirements.

As they may not receive funding from venture capitalists, Government of India needs to support this through a technology upgradation fund. Although the intention of the government to support SMEs is genuine, it is not reflected in adequate funding for the SME sector. The government feels that the Credit Linked Capital Subsidy Scheme (CLCSS), which was earlier announced is meeting the funding for small

sector. But, unfortunately, this scheme is not active and almost redundant. Recently, the government has come with a proposal of ` 500 crores to help the medium sector, but not the small sector. It is important that this funding should be enlarged not only to medium but also to small sector. It will also be not adequate considering the huge funding required by around 7000 pharma SMEs in India. ◗ Training: SMEs require training on GMP practice and skill development. IDMA has been doing its best to conduct seminars on ‘Schedule M & Beyond’ at various venues in India with the help of Department of Pharmaceuticals (DoP). We understand that the Central Drugs Standard Control Organization (CDSCO) is also considering GMP training for SMEs in various parts of India, in order to upgrade Schedule-M. We also need to step up our activities in training on skill development, since India will require a huge number of skilled people to meet the future requirements of the industry. Life Sciences Sector Skill Development Council (LSSSDC) is in the process of setting standards for various cadres and they focus on the skill gaps. ◗ Supplies to institutions Continued on Page 18

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cover ) OUR JOURNEY TOWARDS GLOBAL REGULATORY STANDARDS

O SR VAIDYA Past President, AISDMA , Chairman, SME Committee, IDMA and, Director, Bliss GVS Pharma

ver the years, the posture of both the government, regulatory as well as WHO have been changing and it is noticeable. The government wants to disburse amounts to the identified needy organisations. Regulatory authorities like the CDSCO along with WHO wants human resources to be trained through some skilled development programmes.

DoP has been undertaking programmes all over the country to train and upgrade pharma individuals in the area of GMP and GLP etc. WHO has come forward to train the regulatory inspectors with the right training to carry out necessary auditing of companies. All these parameters are loaded with the objective of creating a viable industry in achieving the global objectives of good quality medicines, to be produced from every unit in this country

and thus, qualify to supply medicines globally.

We still feel a well channelised approach by all state FDA authorities along with the Central Drug Authority and DCI with a definite time line.

The following points should be kept in mind in order to strike the right chord in showing a great improvement. ◗ Identify prospective companies for upgradation, state wise.

They may take the assistance of associations like IDMA, or local associations or federations to help in identifying ◗ Filter out the training needs of personnel and train them to develop the necessary skills ◗ Help these companies to get their capital input needs by influencing the nodal banks to do so ◗ Upgrade the existing machinery profiles so as to provide the right mix of inputs to achieve quality goods ◗ A clear hand holding

‘A SCHEME SIMILAR TO TUFS FOR TEXTILE SHOULD BE GIVEN TO THE PHARMA INDUSTRY AS WELL’

BHAVIN MEHTA Director, Kilitch Drugs India

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T

ill 2000, the pharma industry underwent a technology upgradation every 10 years. Since 2000, this period has reduced to five years. Due to increased competition from the neighbouring countries, it becomes more empirical to look into this aspect since Indian pharma provides the world with finished product formulations at very competitive prices. For the industry to cope with onslaught of technology upgradation and maintain its competitive edge, a scheme similar to Technology Upgradation Fund Scheme (TUFS) for textile should be given to

the pharma industry as well.

The scheme specifically should target: ◗ Promotion of pharma industry, a sunrise sector, for export and employment. ◗ Promoting conversion of existing non-WHO units to WHOGMP accreditation and for improvement in quality and productivity. ◗ Promoting conversion of existing WHO-GMP units to US FDA/MHRA accreditation ◗ Encouraging better productivity and yield improvement

by WHO-GMP units by installing latest technology machines.

approach for a specific number of years is needed to achieve the said ‘quality parameters’ in the industry through friendly regulatory inputs into the system.

It is very pertinent to say, here, that on one side the Centre is interested to set WHO GMP goals in the industry and at the same time, it is crippling the activities of the companies by introducing price controls and squeezing the margins of the manufacturers. One can see the dilemma here, asking for improvement in the infrastructure but, simultaneously, asking for reduced margins and reduced prices. We do not know how many companies can survive this type of manoeuvre by the government. It is indeed a tight rope walk for the companies to satisfy the government, regulatory authorities and also, the people of this nation, at large. Ultimately, it is survival of the fittest. Let us hope that circumstances change, by

which an amicable approach is brought in by the government, bankers and regulatory authorities to keep the pharma flag flying high. The government in recent times has been reiterating that the pharma industry in this country is second, only to the IT industry in terms of economic growth. Incidentally, in the recent Indian Pharmaceutical Congress (IPC) 2015 held in Mysore, the Cabinet minister, Ananth Kumar mentioned in his keynote address, that very soon, there is a plan to moot a separate ministry for pharma.

The Central Health minister, JP Nadda has pronounced that after looking at the active pharmaceutical ingredients (API) situation, they are contemplating announcing incentives for manufacturing of APIs. It is high time that all these pronouncements take shape at a rapid pace in order to develop a good road map for a robust pharma industry

'INDUSTRY NEEDS FINANCIAL...

Continued from Page 17 and hospitals: Recently, the government has come out with the proposal that 20 per cent of the procurement of pharma for Central government institutions has to be taken from the MSME sector. It is a welcome step and will help MSMEs to use their idle capacities. Further, this needs to be extended to purchases from the state governments. It is also important that turnover clause is not stipulated in government tenders, so as to allow a free participation by all SMEs. The turnover clause of ` 20.00 crores and above, have been denying opportunities for SMEs ◗ Exports: SMEs can develop

their plant to WHO-GMP standards and above and they have a huge opportunity to supply to many countries of the world. Hence, SMEs need to be sensitive to export requirements. Atleast, 1000 more exporters can emerge from SME front. ◗ Contract manufacturing: With improved plants and expertise, the SMEs can also be contract manufacturers to national and multinational companies. This will be very timely considering that India will be emerging in a big way in Contract Research And Manufacturing Services. ◗ CEO training: The CEOs of pharma SMEs can be given special training on exports, costing, finance management and the importance of R&D and technology.

PROPOSED REVISION OF SCHEDULE M WILL BE BENEFICIALTO UNDERSTAND AND IMPLEMENT GMP IN ATRANSPARENTWAY

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DR D ROY Former Deputy Drugs Controller (India), CDSCO, MoHFW, Govt. of India

here is a necessity to revise Schedule M (GMP norms) of D&C rules.

Good Manufacturing Practice (GMP) is essential to maintain the ‘quality’ of medicines. It is a dynamic process and norms should be revised from time to time with advancement of good practices.

It was first incorporated in 1988 in Schedule M of D&C Rules to enhance the quality of pharma products manufactured in India. However, due to the directive of National Human Rights Commission, the Schedule M was revised in the tune of GMP for pharma prod-

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ucts prescribed by WHO for the member countries vide WHO TRS 823 and gazette notification was made by MoHFW (Department of Health) on December 11, 2001.

WHO upgraded TRS 823 version to 902/908/961/986 with a number of supplementary guidance documents during the last decade. ‘Orange Guide’ — the GMP norms followed by MHRA have been revised eight times since its first introduction in 1971. PIC/S guidelines on GMP are revised every year. Following are the major gaps between Schedule M of D&C Rules and

WHO GMP Norms.

Quality management ◗ A Pharmaceutical Quality System (PQS) [which specify that the top management should bear the responsibility to ensure that the products manufactured are complied with the requirements of the manufacturing license and do not jeopardise the health of the patient due to inadequate safety, quality or efficacy of the product] is not mentioned in Schedule M and requires to be incorporated in the tune of WHO TRS 986, Annex-02. ◗ Quality Risk Management

(QRM) [which is a systematic process for identification, assessment and control of risks to the quality of pharmaceutical products across the product lifecycle] is not mentioned in Schedule M and requires to be incorporated in the tune of WHO TRS 986, Annex-02. ◗ Product Quality Review (PQR) [which is an effective quality improvement tool to enhance the consistency of the process and the overall quality of the product] is not mentioned in Schedule M and requires to be incorporated in Continued on Page 20

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cover ) 'THERE IS A NEED FOR A SIGNIFICANTTECHNOLOGY UPGRADATION SUPPORTTO THE MSME SECTOR'

A

VIRANCHI SHAH Vice Chairman- IDMA GSB, Chairman- National Council on Drugs & PharmaceuticalsASSOCHAM, MemberForeign Trade CommitteeGCCI

SME plant, that could be set up in less than ` 1 crore a decade back today requires about ` 20-25 crores. Upgradation of existing facilities is highly capital intensive too, running easily into ` 5-10 crores. Ancillary aspects such as HVAC, water systems and utilities are capital intensive.

Stringent systems need to be in place to adhere to GMP thus resulting into higher running costs. Escalating manpower costs and energy costs are incidental. In a nutshell, both capital costs as well as running costs have gone up. For MSMEs, it is quite overwhelming to cope up to this. With limited profits and investment capabilities coupled with high market uncertainties and ever changing regulations, it is quite challenging for them to get motivated to invest more.

Some experts believe that MSMEs will cease to exist in the pharma industry if this

trend continues for another 10 years, as the threshold investment will be too much for new MSME entrants or even for the existing MSMEs to survive.

Certain solutions can be considered:

Govt support subsidy There is a need for significant technology upgradation support to the MSME sector. CLSS has its limitations that it gave too little (upto ` 15 lakhs) and was too cumbersome. The need of the hour is a more comprehensive and industry- friendly scheme. The subsidy limit needs to be increased to ` 5 crores with simple procedures.

Soft loans Most of the financing required for MSME upgradation needs to be financed through debts.

Soft loans with low interest rates, minimal collateral requirements and simple procedures are a must.

Business support MSME may be given some preference in government procurement tenders. This could be either in terms of reserved products or rate advantage.

This could help this sector get better mark ups which can be used to finance the upgradation.

Skill development In line with the PM’s vision, ◗ The government needs to put in a large investment in skill development for pharma industry. ◗ Support from industry association and regulators FDCA and CDSCO can play mentors to MSME sector on how best to upgrade and still keep costs under control, where industry associations like IDMA and FOPE can facilitate this interaction. Regular training programmes and continuous education on GMP, involving the regulators and industry can go a long way to create a

GMP complaint MSME industry. ◗ Initiatives from entrepreneurs and stakeholders MSME pharma industry has to brace itself to international norms. They have to accept that they cannot continue their business tomorrow with practises of day-before-yesterday. The first thing is to get away from fears and reservations. Many GMP compliance activities may not need a big investment. Putting good quality systems in place, internal training and maintaining data integrity are small but significant steps show their commitment to move forward. Many GMP compliance activities may not need much of monetary commitment, but can make a very contribution towards GMP compliance. The future of MSME sector is very bright.

We need a bit of hand holding from all stakeholders, government, banks etc.

PROPOSED REVISION OF SCHEDULE M...

Continued from Page 19

Name of guideline

Technical Report Series

the tune of WHO TRS 986, Annex-02. ◗ A definition of Good Manufacturing Practice (GMP) and its contents should be defined clearly in the tune WHO TRS 986, Annex-02.

WHO TRS 961,Annex-05

HVAC System for non-sterile Dosage forms

WHO TRS 929,Annex-03

Water System

Table 1

WHO TRS 937,Annex-04, (Non-Sterile Qualification & Validation Process Validation WHO TRS 992,Annex-03)

Quality control

WHO TRS 953,Annex-02

Stability Studies

WHO TRS 929,Annex-04

Sampling

Personnel

WHO TRS 981,Annex-02

Quality Risk Management

◗ Details of duty and responsibility of key personnel like head of production, head of quality control and head of quality assurance should specifically be stated in Schedule M as described in WHO TRS 986, Annex-02. ◗ Details of training to be imparted to all employees engaged in manufacturing and quality control activities at the time of induction as well as ongoing including maintenance of

WHO TRS 978,Annex-03

Manufacture of Biological Medicinal Products for Human Use

WHO TRS 908,Annex-03

Manufacture of Radiopharmaceuticals

WHO TRS 937,Annex-03

Manufacture of Herbal Medicinal Products

WHO TRS 952,Annex-02

GMP for Active Pharmaceutical Ingredients

20 EXPRESS PHARMA February 16-29,2016

records should specifically be stated in Schedule M as described in WHO TRS 986, Annex-02.

ment require to be stated more elaborately in Schedule M as described in WHO TRS 986, Annex-02.

Equipment

Manufacturing operation and control

Installation, qualification and maintenance criteria of equip-

◗ More emphasis for prevention

personnel protection is required to be incorporated more elaborately in Schedule M as described in WHO TRS 986, Annex-02.

of contamination and cross-contamination is required and accordingly these criteria should be prescribed more elaborately in Schedule M as described in WHO TRS 986, Annex-02. ◗ Necessary safe guard requirement for environment as well as

Although GLP is specified in Schedule L1 of D&C Rules, however, the requirement of the same should be incorporated in Schedule M as described in WHO TRS 986, Annex-02.

Contact manufacture and analysis Although the provision of contract manufacturing is well covered under rule 69A and 75A, however, due to modern scenario of contract manufacturing industry in India, the clause of contract production and analysis should be incorporated in Schedule M covering all the

points as specified in WHO TRS 986, Annex-02.

Specific requirements for manufacturer of sterile product (Part 1-A) ◗ More emphasis for sanitation is required and accordingly these criteria should be prescribed more elaborately in Schedule M as described in WHO TRS 961, Annex-06 (which is current WHO GMP Norms for sterile pharmaceutical products and was published in 2011). ◗ The criteria for sterilisation by radiation and gasses should be included in Schedule M as described in WHO TRS 961, Annex-06 ◗ The criteria for process simulation test require to be included in Schedule M more elaborately as described in WHO TRS 961, Annex-06. ◗ The criteria to maintain cleanliness level throughout the processing operation during manufacturing of sterile preparation should be prescribed more elaborately in Schedule M as described in WHO TRS 961, Annex-06.

Guidance documents WHO published various guidance documents to facilitate the manufacturers to understand clearly the basic elements of various GMP components and their implementation in proper way to assure quality, safety and efficacy of the product.

Some of examples are shown in Table 1 Such guidance documents are not available for the manufacturers neither under Schedule M nor under D&C Rules. In absence of such guidance documents, there is always a probability of different interpretations of the norms by various manufacturers as well as regulators.

Absence of these guidance documents are major gaps in Schedule M in comparison with WHO GMP guidelines.

In view of the above and considering developments in the field of pharma technology and increase regulatory expectation to improve the quality, safety and efficacy of the pharmaceutical products, there is a necessity

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to revise and upgrade the main principles and concept of GMP mentioned in Schedule-M in the tune of WHO TRS 986, Annex-2 & 961, Annex-6 (for sterile products) to fulfill international

regulatory commitment.

The proposed revision will not attract more cost on infrastructure facility for the present manufacturing unit rather will be more beneficial to

understand and implement GMP in a transparent and unambiguous way to ensure safety, efficacy and quality of the pharmaceuticals products. However, the cost may be involved to train

human resources, prevent contamination/cross contamination, maintain water for pharma use in constant circulation loop and provide terminal HEPA filter in a multiproduct OSD facility.

MANAGEMENT INSIGHT

The age of prodices Susan Josi, Managing Partner, Sorento Healthcare, gives an insight on why healthcare companies must build new models of innovation that are anchored in consumer-centric disease solutions rather than traditional R&D department approaches

“The illiterate of the 21 st century will not be those who cannot read or write but those who cannot learn, unlearn and relearn” Alvin Toffler, American writer and futurist

C

asting our minds back a few years, would any of us have thought that the who’s who in healthcare – besides the Big Pharma companies – would be tech titans such as Google, Apple and Samsung? With the way they are going today, it will not be long before they rule the healthcare business.

So what exactly is causing this tectonic shift in our industry? Convergence of expanded access, speed of innovation, the advent of personalised care and, most importantly, a growing demand for improved health outcomes have created ripples that are already altering the course of economics and operating dynamics of healthcare.

It is becoming clear that the consumer of today is no longer just a sufferer of a disease, but a super consumer whose demands and choices are growing more sophisticated. In other words, they are the reason why healthcare companies must build new models of innovation that are anchored in consumer-centric disease solutions rather than traditional R&D department approaches.

22 EXPRESS PHARMA February 16-29,2016

SUSAN JOSI, Managing Partner, Sorento Healthcare

Welcome to ‘Prodices’ At a time when technologies are converging and boundaries are blurring, the once clear divide between product and service is becoming hazier. So how do we create consumer-centric solutions in the context of the brands we handle and the ailments they treat? The answer is to take the best of both worlds – the advantages without the disadvantages.

Welcome to the age of 'Prodices', a term coined by pharmacist and author Jordi Bernal Fiego to describe hybrids of products and services, which seamlessly integrate the original advantages and features of each and offer a solid value proposition for the consumer.

I was completely sold on this concept when I heard it for the first time a couple of years ago and, although it is far more evolved in the context of healthcare, we can think of it in a more simplistic fashion while implementing it.

We always link service agreements and contracts with the various consumer durables we buy at home. The reason?

We are conscious of the high cost and the long-term investment we make in these products. In many cases, our choice of buying a good brand of television or refrigerator is linked to the service provided more than just the features and benefits. The premise of developing a Prodice model for your OTC brand is no different, as you visibly see every consumer of your brand as a return on investment for the long term.

We have in fact implemented such services, even though in very simplistic ways, whether it is a helpline or a website, and now increasingly the creation of mobile apps. While this is certainly a beginning towards building a Prodice model, we treat it as a discretionary service for our brand that is most often implemented as a differentiator when launching in a cluttered market. It is not pursued holistically and, more importantly, non-negotiably.

So, is the status quo a fruitful investment? And will it really serve the purpose if we do

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not make it a much necessary tool along with our brand?

The fact remains that what

the world needs today is a service that clearly creates brand engagement for the

long term and can provide a good amount of data to help us understand our consumers

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MANAGEMENT

better and inspire the kind of innovations and new products we need to launch in the future. It is indeed time to push the envelope and explore greater opportunities with this model. Your brands are asking for it.

brands with Abbott, thus leveraging real-time patient information with its bouquet of products, tied in with a patient advisory service.

Many companies are starting to venture into this space, which is leading to a marriage of sorts between traditional pharma / medical device companies and technology / patient care companies that have leveraged technology to manage patients more effectively. A recent development in this trend has been Medtronic’s acquisition of Diabeter, an innovative Netherlands-based diabetes clinic and research centre dedicated to providing comprehensive and individualised care for children and young adults with diabetes.

Together the two will develop and expand Diabeter’s model of care so that more people with diabetes can enjoy greater freedom and better health.

The future of medicine is in information technology In the popular TV series Star Trek, Captain Kirk has a handheld device called a tricorder that can immediately assess a patient’s condition and diagnose a disease. This is supposedly 300 years in the future but, in real life, technology is advancing so rapidly that within a decade Kirk’s tricorder will look as primitive as a pager. Just as our bathroom scales give us instant readings of our weight, our smartphone tricorders will monitor our health and warn us when we are about to get sick. The future of medicine lies in this integration of technology and the human body.

Our smartphones already contain a wide array of sensors, including accelerometers that keep track of our movement, high-definition cameras that can photograph external ailments and transmit them for analysis, and global positioning systems that know where we have been. All of these devices can feed data into our smartphones and cloud-based personal lockers – turning it into a medical device, as opposed to a mere gadget.

The 'Quantified Self' movement aims to measure all aspects of a person’s daily life with the help of technology.

Wearable devices, such as activity trackers, combined with apps allow us to log every step, snack and snooze to bring a better understanding of our body and health.

Continuum of care A more futuristic prospect is available to create a Prodice model for brands to straddle the continuum of care from diagnosis to treatment adherence and monitoring, to ensure that health outcomes are positive. The key to developing this

24 EXPRESS PHARMA February 16-29,2016

Time to own the ailment

PRODICES: EXAMPLES OF PRODUCT + SERVICE HYBRIDS

The concept of Prodices is still in its infancy but some healthcare companies have already implemented these types of services in basic ways.The following are some examples of Prodices currently available to consumers: ◗ iCan (Piramal Enterprises). In India, Piramal launched the i-can help webpage to support its pregnancy test brand, which answers common queries about pregnancy and provides details on where to buy the product ◗ Elevit (Bayer). In S Korea, Bayer updated the

model is to map the consumer’s journey more intimately in a bid to understand the various interventions needed to help them get a more positive outcome while managing their condition. These interventions can be varied and, in many cases, cannot be addressed by one company alone. Therefore co-creation through collaborations or acquisitions will be the

website for its pregnancy multivitamin brand to include information such as how to prepare for pregnancy, as well as an ovulation calendar to help with conception ◗ Benza (Takeda).Takeda operates an online pollen forecast to support cough, cold and allergy brand Benza in Japan ◗ Calpol (J&J). In the UK,J&J developed a smartphone app for children’s systemic analgesic Calpol, which includes features such as a temperature tracker and symptom checker

order of the day.

The April 2015 launch in India of Abbott’s FreeStyle Libre Pro Flash Glucose Monitoring System, which provides the ambulatory glucose profile of a diabetic patient, is case in point. The report generated provides a visual snapshot of a person’s typical day – revealing hypoglycemic and hyperglycemic trends to facilitate

better patient therapy and education. So, while doctors are able to understand how their patients’ glucose levels change and how to treat them, the important aspect would be to also provide the relevant supportive care in terms of real-time diet and lifestyle modifications needed in the patient’s life. This is an ideal opportunity to build a Prodice model for diabetes

It is evident that the most enterprising healthcare companies of today are preparing to embrace a distinctly different future in this domain. These early movers are attempting to secure their innovation and organisational efforts around the concept of “owning the ailment” – as opposed to merely “treating” it – with products, services and solutions across the entire continuum of care.

While the number of such companies is small and they are yet to be fully successful, their influence is growing. As their efforts advance, they serve as a harbinger of a new, dominant business model for the industry. One that has consumer centricity as its sum and substance.

“I think the biggest innovations of the twenty-first century will be the intersection of biology and technology. A new era is beginning” Steve Jobs, Steve Jobs by writer Walter Isaacson (Nicholas Hall's OTC INSIGHT Asia-Pacific August 2015)

RESEARCH RESEARCH UPDATES

Pfizer,J&J,Merck evaluating technologies for Zika vaccine However, scientists and experts have said producing a safe and effective vaccine will take time PFIZER, JOHNSON AND Johnson and Merck & Co said they were evaluating their technologies or existing vaccines for their potential to combat Zika, a rapidly spreading mosquito-borne disease linked to birth defects. A number of drug developers and universities are attempting to produce a vaccine for Zika, which the World Health Organization

(WHO) has declared an international health emergency.

But scientists and experts have said producing a safe and effective vaccine will take time.

“Pfizer is currently analysing its existing vaccines portfolio in response to the Zika outbreak to see where we might be able to play a role,” Pfizer spokeswoman Sharon Castillo said. Japan’s Takeda

Pharmaceutical said it had created a team to investigate how it might help make a vaccine, a day after Sanofi said it would launch a Zika vaccine programme.

Meanwhile, the first known case of virus transmission in the US was reported in Texas by local health officials. Paul Stoffels, Chief Scientific Officer at Johnson and Johnson's

Janssen unit, said the company is currently evaluating if any of its available technologies could be directed to address Zika.

“At this stage, it is premature to say how long this might take or speculate on the out-

come,” Stoffels said. Merck, which helped develop the first successful Ebola vaccine, said it was working with public health partners to see how its expertise could be useful.

Reuters

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RESEARCH

Beard bacteria could lead to new antibiotics Swab samples were taken from 20 beards, with at least 100 bacteria growths detected THE LOOMING crisis of antibiotic resistance means diseases that were once easily treatable are becoming deadly again. The over-prescription of antibiotics for conditions that don’t require them is spurring resistant mutations leading to so-called superbugs - multi-drug-resistant infections that can evade the medicines designed to kill them.

"What we’ve done as a human species is to basically coat the world in antibiotics by our overuse and inappropriate use. So, we’ve selected for these resistance mechanisms in the bacteria, so it’s why we’re seeing the problem that we’re seeing now," said microbiologist Dr Adam Roberts from University College London.

The race is now on to develop new medicines to treat these emerging, mutating infections. Only a few new antibiotics have been developed and brought to market in the past

few decades, but one surprising source of hope has recently emerged – beards. The discovery came after a separate study to test the theory that most beards contain traces of faeces.

Swab samples were taken from 20 beards, with at least 100 bacteria growths detected.

“There was a previous study that showed there was a lot of faecal bacteria present in some of the beards analysed,” Roberts said. “We wanted to either disprove or prove that that was actually correct, and we could find no evidence of that.”

Microbiologists subsequently ran tests on all of the isolates that were taken from the beards as part of the research into new antibiotics.

"What we do is grid out the individual bacteria on an agar plate which has been pre-inoculated with an indicator strain. And then we see if that indicator strain can grow right up to the

individual colonies from the beards or from anywhere else that we've got these bacteria from," explained Roberts.

"And we found, quite surprisingly, that the beard isolates were quite capable of killing the indicator strain that we have; showing that they actually produce antibiotics themselves."

Of about a hundred bacteria isolates taken from 20 beards, around 25 per cent of these

showed antibiotic activity against their indicator strain.

Medical science is currently in what's known as a "discovery void", with very few new antibiotics developed since the socalled 'golden age' of discovery in the 1950s and 60s. A recent British report estimated that antibiotic and microbial resistance could kill an extra 10 million people a year and cost up to $100 trillion by 2050 if it is not brought under control.

The team at UCL is part of a global effort to find new antibiotics before this crisis becomes more desperate. He said that while it might seem contradictory to be looking for even more antibiotics when it was their overuse that in-part triggered the current situation; having a raft of new medicines available would allow doctors to limit how long they are used for before they were put aside for a number of years. This

would put less pressure on the bacteria to evolve resistance.

Roberts has been asking members of the public to send in swab samples to his laboratory from places where bacteria might be thriving. He said there have been some promising results. "We've got other samples from all over the country; from child's trampolines, to fridges, to cats. We've now got a selection of around 50 different bacteria which can kill multiple indicator strains. These include E.coli - a multi-drug resistant E.coli from a urinary tract infection. These include also Candida albicans [yeast infections] and MRSA [Methicillin-resistant Staphylococcus aureus]. So we're concentrating our efforts now on finding out exactly what these bacteria are producing, because there's just a small possibility that it might be a novel antibiotic."

Reuters

Britain gives scientist go-ahead to genetically modify human embryos The scientists will not be allowed to develop the modified embryos for clinical purposes or implant them into any women SCIENTISTS IN Britain have been give the go-ahead to edit the genes of human embryos for research purposes, using a technique that some say could eventually be used to create ‘designer babies.’

Less than a year after Chinese scientists caused an international furor by saying they had genetically modified human embryos, Kathy Niakan, a stem cell scientist from London's Francis Crick Institute, was granted a license to carry out similar experiments. "The Human Fertilisation and Embryology Authority (HFEA) has approved a research application from the Francis Crick Institute to use new 'gene editing' techniques on human em-

26 EXPRESS PHARMA February 16-29, 2016

bryos,” Niakan’s lab said. It said the work carried out “will be for research purposes and will look at the first seven days of a fertilised egg’s development, from a single cell to around 250 cells.” The scientists will not be allowed to develop the modified embryos for clinical purposes or implant them into any women.

Niakan plans to carry out her experiments using what is known as CRISPR-Cas9, a technology that is already the subject of fierce international debate because of fears that it could be used to create babies to order.

CRISPR can enable scientists to find and modify or replace genetic defects. Many

experts have called it “gamechanging.” David King, director of the UK campaign group

Human Genetics Alert, said Niakan's plans would eventually lead to “a future of consumer eugenics.” “This research will allow the scientists to refine the techniques for creating GM babies,” he said.

But Sarah Norcross, director of Progress Educational Trust, which campaigns for ethically sound research in genetics, said the HFEA’s decision was “a victory for levelheaded regulation over moral panic.” Niakan says she has no intention of genetically altering embryos for use in human reproduction, but wants to deepen scientific understanding of how a healthy human embryo develops, something that could, in the long term,

help to improve infertility treatments such as in vitro fertilization (IVF).

The work will be carried out on embryos that have become surplus to donor patients IVF treatment. At a briefing for reporters in London last month, she said the first gene she planned to target was one called Oct4, which she believes may have a crucial role in the earliest stages of human fetal development.

Bruce Whitelaw, a professor of animal biotechnology at Edinburgh University's Roslin Institute on Scotland, said the HFEA's decision had been reached "after robust assessment.”

Reuters

RESEARCH

Tendon pain linked to type II diabetes The study team also found that people with diabetes were more likely to have thickened tendons, which is often seen in tendinopathy EXERCISE IS important to managing type II diabetes, but the condition may also make a person prone to tendon pain, which can interfere with exercise, researchers say.

Based on an analysis of past studies, researchers found that people with type II diabetes are more than three times as likely as those without the disease to have tendon pain, known as tendinopathy. And people with diagnosed tendinopathy have 30 per cent higher odds of having diabetes.

The findings may indicate a problem healthcare providers need to be aware of, the study’s senior author said. “People with diabetes are more likely to develop tendinopathy, but the opposite is also true - people with tendinopathy are more likely to have undiagnosed diabetes,” Jamie Gaida said.

“Tendinopathy is a problem for two key reasons,” he said. “First, feeling pain during movements that load the tendon is unpleasant, and second, having a painful tendon stops you being physically active.”

People with diabetes “should absolutely be physically active, as it is one of the most effective treatments for diabetes,” said Gaida, an assistant professor and physiotherapist at the University of Canberra in Australia. Tendinopathy refers to injuries and inflammation of the tendons, the soft tissues that connect muscles to bones, usually due to overuse or repetitive movements.

Having injured tendons may make it difficult to stick with exercise programmes, which are essential for management of diabetes.

One past research review has also linked diabetes and increased risk of tendinopathies, the authors of the new study note in the British Journal of Sports Medicine.

To examine the relationship further, Gaida and colleagues reviewed 31 previous studies. 26 of them focused on people with type II dia-

betes while five focused on people with diagnosed tendinopathy. When they combined and reanalysed the data in all the studies, Gaita’s team found that people with type II diabetes were 3.67 times more likely to develop tendinopathy compared to control participants without diabetes. People with tendinopathy were 1.3 times more likely than controls to have diabetes. The study team also found that people with diabetes were more likely to have thickened tendons, which is often seen in tendinopathy. And people with both tendinopathy and diabetes typically had been diagnosed diabetic for longer than those with diabetes but no tendon problems.

“The risk of tendinopathy increases with the number of years that you’ve had diabetes,” Gaida said.

Physical activity is one of the most effective treatments for diabetes and tendinopathy can be one of the worst things for diabetes management as it stops physical activity, he said, adding that people who develop tendon pain should seek medical advice early for the speediest recovery.

“Physiotherapists/Physical Therapists are uniquely skilled to help you recover from tendinopathy and return to your chosen activity,” Gaida said.

People with diabetes shouldn’t see this study as a reason to stop exercising, stressed Dr I Martin Levy, director of the orthopedic surgery residency programme at Montefiore Medical Center in New York.

Levy said that people with diabetes should take a measured approach to any type of exercise or activity. “I think whatever exercise program that you are going to take, use common sense, and start off slowly.”

Reuters Health

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PHARMA ALLY I N T E R V I E W

‘Our recent initiative is an effort to provide innovative and cuttingedge technology to our customers’ ZIM Integrated Shipping is a leading player in the global container shipping industry.

Nissim Yochai, VP Global Sales, ZIM Integrated Shipping, in an interaction with Usha Sharma, talks about ZIMonitor technology and it’s contribution to the pharma industry ZIM Integrated Shipping Services has recently expanded its service to the refrigerated container fleet.

What made you venture into this sphere?

ZIM has always carried refrigerated cargo and was a prominent player in reefer cargo in certain trades for many years. Our recent initiative is an effort to provide innovative and cutting-edge technology to our customers through the use of our ZIMonitor technology and services. This new product is exclusive and unique in the market. We are convinced that our distinctive ZIMonitor service will benefit customers and strengthen our position in this market.

Early last year, you have launched ZIMonitor service in India. Tell us more about the product and its services.

ZIMonitor is a comprehensive service package which include technology and professional personnel to provide shippers of valuable and sensitive cargo damage prevention capabilities and reduced risks. It provides ongoing data flow, alerts and automatic reports, along with a 24/7 professional response along the cargo route to prevent damages.

The main features: ◗ Online alerts to mobile and email, monitoring temperature, humidity, route deviation and unauthorised door opening

28 EXPRESS PHARMA February 16-29,2016

◗ 24/7 dedicated ZIM response team to prevent damages ◗ GDP compliance ◗ Predefined reports for logistical and operational analysis ◗ Reducing insurance costs The online monitoring service is also suited for other types of valuable or sensitive cargo such as medical lab equipment; aviation products; perishable foodstuffs; wines and other alcoholic beverages; agriculture (seeds); electronics; art work and antiques; as well as hazardous or IMDG code goods.

How big is the Indian cold chain pharma market? With the help of ZIMonitor service how much market share do you plan to capture and how?

The Indian market is substantial and we believe our unique service will enable us to become a significant player in this highly professional field, however, these are early days and at this stage we will not indicate figures.

What regulatory parameters do ZIMonitor complies to and how do you ensure that the temperature is maintained for pharma products?

ZIMonitor is particularly suited for the pharma industry, designed to comply with Good Distribution Practices (GDP) regulations required by the industry.

As to temperature control,

ZIMonitor technology uses sensors monitoring temperature throughout the voyage, both at sea and on land, from the point of origin to final destination. The sensors indicate any change in the required temperature, and send immediate alerts to the shipper and to ZIM’s response team whenever the required temperature is not maintained.

ZIMonitor has many more advantage to customers, for example providing detailed reports in industry-required formats, and additional features suited perfectly to the strict demands of the pharma cold-supply chain, such as potential insurance benefits and more.

We are convinced that our distinctive ZIMonitor service will benefit customers

Tell us about the USP of the ZIMonitor service and is it cost effective?

Our USP is to prevent damage of valuable cargo following an alert. Unlike other products in the market, the alert is just the first stage, launching an immediate response of professional staff that remedy the situation and prevent any damage to the cargo. Our ability to respond and provide a solution to any problem that might occur during the voyage, providing our customers with peace of mind at all time is our main USP. Whom do you consider as your competitor and why?

There are several competing

products in the market, however, none of them provides, to our knowledge, a full comprehensive solution catering to customers’ needs.

ZIM has also partnered with TEVA Pharmaceutical. Can you throw some light on the partnership?

TEVA is a leading global player in the pharma industry, shipping pharma products to many destinations worldwide.

ZIM has been providing shipping services to TEVA. Indeed, we partnered and followed several successful pilot shipments, conducted in close cooperation with TEVA. We launched the service and continued our cooperation to benefit both the parties.

How many domestic as well as multinational pharma companies are willing to partner with you? How soon it is likely to happen?

This is naturally a long-term process, however, we receive a lot of interest from the industry, and we make a point of presenting ZIMonitor in trade fairs and exhibitions of the industry in order to inform the industry and introduce the benefits of ZIMonitor.

The reactions we receive are extremely positive and believe the ZIMonitor service will continue to grow and develop. u.sharma@expressindia.com

PHARMA ALLY I N T E R V I E W

‘Our focus is mid and large Indian companies’ Johannes Giessler, Director Sales & Marketing, Perlen Packaging talks to Express Pharma about its strategy for the Indian market and the company’s future prospects As the global leader in high barrier PVdC films for blister packaging, what are the benefits of high barrier PVdC films over traditional aluminum packaging?

Aluminum is expensive and many products packed in Cold Form (Alu) packs do not require such high barrier. These can easily be packed in high barrier blisters - thus saving cost. The pack size is reduced thus reducing overall cost of packaging and transportation. Also, reduces shelf space on retailer shelf making it attractive for the retailer.

What is the value proposition to justify the higher costs?

The product helps in overall reduction in cost, thus improving product profitability. Also, the product is visible, which is known to have a positive psycological impact on the patient.

What are the further product innovations planned for markets like India, where climate conditions demand more robust packaging?

Innovations in having high barrier and ultra high barrier and keeping the costs down is the focus of Perlen.

It is for this reason that Perlen has a new facility coming up in China.

This factory will be able to provide European quality at affordable prices to the Asian subcontinent including India.

What are the packaging solutions for highly sensitive/potent APIs? Ultra high barrier packaging from Perlen is the answer. This packaging material has been adapted for

2016 will be a turn around year where we expect to ride high on commercial order which we will receive EXPRESS PHARMA

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February 16-29,2016

PHARMA ALLY hundreds of sensitive formulations globally. Perlen can test your product and provide you with data regarding the type of film that will best suit the product.

What is your customer mix as of today, in terms of MNC, mid-sized pharma?

Our focus is mid and large Indian companies who are targeting highly regulated markets like Europe, the US and even Japan. Perlen provides Japanese quality packaging films which meet Japan's regulatory requirement.

Perlen Packaging's strategy is to offer pharma clients the highest barrier films in the market. What is the range of your offerings in terms of pharma films and what are the consumer trends shaping this segment?

We have a complete range of

30 EXPRESS PHARMA February 16-29,2016

barrier properties for water vapour and oxygen barrier.

Depending on the requirement and properties of the medicament, the barrier film can be selected from the wide Perlen range.

Perlen Packaging's new film coating production facility in China is projected to start operations by April this year.

What is the role of this new facility in the company's plans for the Asian market?

The facility equipment are under installation and validation. We expect commercial production to start in April or May 2016. The objective is to meet the demands of the Asia Pacific region - including India from this facility. Once local approvals are obtained, we shall begin marketing the barrier films in china as well.

Perlen Packaging has many

We expect to book up our China capacities with orders from India local competitors in India and Asia market. What is the strategy for India? How will Perlen be able to match them in terms of pricing? Will the company be able to give Swiss quality at local prices?

Competition is stiff - however, main competition is from products being imported from the US to prepare barrier packaging in India. Perlen will have an edge in terms of pricing and quality compared

to existing competition. Once our China facility kicks off, we will not just have the price advantage but also the advantage of deliver times.

What has been the growth of your business in India?

Where are the other growth markets, in Asia and globally? What percentage of global revenues come from Asia and specifically India?

We have entered India in a systematic and steady manner.

Sampling of our products is on and many companies have put products in our barrier packaging films on stability.

2016 will be a turn around year where we expect to ride high on commercial order which we will receive.

Perlen Packaging clocked annual revenues of euro 120 million in CY2014. What do the CY2015 figures look like?

What is the growth percent-

age?

If all goes will, we expect to book up our China capacities with orders from India. Perlen has been growing at a steady rate and expected to grow with the growth rates similar to the pharma industry - a steady double digit growth.

What is the strategy to grow revenues in CY2016 and to 2020? Globally as well as at a regional and country-level.

Greater market penetration is the only strategy. Perlen is clear that it will keep its focus on pharma and not get into any other industry.

What are the pharma packaging trends you predict for 2016?

As an immediate need in 2016, cost-effective high barrier packaging is the need of the industry and Perlen is there with its product range.

EP News Bureau-Mumbai

PHARMA ALLY VENDOR NEWS

SCHOTTsees sales and annual results climb Supporting ‘Make in India’ campaign through sharing of advanced technology and increased share of exports to 40 per cent of total sales SCHOTT PLANS to push ahead and continue with its growth strategy globally and for India in particular.

The Group’s EBIT reached euro 178 million, marking a major increase from the euro 135 million in Fiscal Year 2013/2014. “Our focus was primarily on improving profitability in 2015, a goal which we fully met. Needless to say, we are pleased with the results of the last fiscal year,” emphasised Dr Frank Heinricht, Chairman of the management board, at the company’s recent annual results press conference.

Global sales were up by three per cent to euro 1.93 billion (euro1.87 billion) in fiscal year 2015 over previous year. For SCHOTT in India, sales in euro terms increased significantly, with the growth rate in double digits.

The consolidated sales figure for the group was euro 82.4 million out of which approximately 30 per cent was exported. The main area of growth for India in FY2015 was domestic and export sales of tubing and packaging products for pharmaceutical industry, and special tubing for automobile halogen lamps. Another area of success was flat glass for home applications such as hop tops.

“We are pleased with the annual result for all divisions of SCHOTT. Our increased share in exports as well as successful joint venture of SCHOTT KAISHA are successful proof points of SCHOTT’s participation in the government’s ‘Make in India’ campaign, as well as our will to support exchange of advanced technology and knowledge,” said Murali

Global sales were up by three per cent to euro 1.93 billion (euro1.87 billion) in fiscal year 2015 over previous year Viswanathan, Managing Director — Sales Office, SCHOTT Glass India.

For the current fiscal year, SCHOTT plans to continue with a focus on growing its business. The company anticipates a sales increase somewhere between three and five per cent globally, achieved through consistently improving its profitability and accelerating growth for highly potential markets such as India. “In the years ahead, we are looking to successfully launch a number of innovations in the market. In addition, we want to grow our company in target regions as well as through acquisitions,” states Heinricht.

“According to India Ratings, a Fitch company, the Indian pharma industry is estimated to grow at 20 per cent compound annual growth rate over the next five years. SCHOTT aims at catering to this growing demand, via our products which adhere to global standards of quality and high safety measures,” said Heinricht.

EP News Bureau-Mumbai

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PHARMA ALLY PRODUCTS

Waters introduces CORTECS C8 and Phenyl 1.6 and 2.7 micron columns WATERS CORPORATION has introduced two new chemistries to its CORTECS Columns product family. Built on Waters proven solid-core particle technology, the Waters CORTECS C8 and CORTECS Phenyl analytical columns are designed for scientists who need to expand their chromatographic separation space while maximising the speed, resolution and sensitivity of their small molecule HPLC, UHPLC or UPLC separations. Capable of operating at very high column efficiencies and low backpressures, the new columns give scientists additional selectivity choices and allow them to develop methods quickly, and generate more information with every analytical run. The CORTECS C8 and CORTECS Phenyl chemistries are available in two particle sizes, 1.6 and 2.7 micron, and are offered in a total of 50 unique column configurations.

CORTECS C8 Columns exhibit a lower hydrophobicity when compared to typical bonded C18 phases and are useful for separating strongly

32 EXPRESS PHARMA February 16-29,2016

hydrophobic compounds.

They are also ideal for chemists looking to transfer or scale compendial C8 HPLC methods to a more robust column technology.

CORTECS Phenyl Columns are an excellent al-

ternative to typically bonded C18 phases, particularly for aromatic compounds, based on the unique selectivity provided by the Phenyl bonded phase.

Both the 1.6 and 2.7 micron CORTECS C8 and CORTECS

Phenyl columns are fully scalable for the seamless transfer of methods between the two particle sizes.

The CORTECS UPLC 1.6 micron particle columns are designed to yield maximum efficiency when used with the

ultra-low dispersion Waters ACQUITY UPLC instrument platform. In the separations market space, CORTECS UPLC 1.6 micron columns offer to scientists previously unattainable levels of performance.

The CORTECS 2.7 micron particle columns are designed for maximum flexibility for use on both UHPLC and HPLC instrument platforms.

CORTECS 2.7 micron columns run at lower backpressures while delivering high efficiencies, which allows for the use of longer column lengths to improve resolution or higher flow rates to speed instrument analysis times and increase throughput.

The two new chemistries complement the existing CORTECS C18+, C18, and HILIC chemistries in Waters current CORTECS product portfolio.

Contact details Waters Corporation Brian J. Murphy, +1-508-482-2614 Public Relations Manager brian_j_murphy@waters.com

PHARMA ALLY

Phenomenex expands chiral screening and separation power with New Lux 3μm Amylose-1 Chiral Columns PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has added a 3μμm particle size to the company’s newest chiral selector, Lux Amylose-1, amylose tris (3,5dimethylphenylcarbamate).

These high-efficiency Lux polysaccharide columns are ideal for UHPLC, HPLC and SFC chiral screening and analysis, and now with two sizes – the new 3μμm and existing 5μμm particles – method scalability from analytical work to preparative purification is seamless.

The affordable Lux Amylose-1 provides valuable enantioselectivity and is a guaranteed alternative to other phases with the same chiral selector. The 3μμm-particle media is available in analytical columns while the 5μμm-particle media is available in both analytical columns and Phe-

nomenex-patented Axia preparative column hardware, both of which are stable in normal phase, reversed phase, polar organic and SFC conditions.

The Phenomenex Lux

amylose and cellulose chiral column line of six chiral selectors comprise an affordable and complementary kit for chiral separations, featuring high efficiency, excellent loading capacity and pressure sta-

bility up to 300 bar in a wide range of conditions. Ideal applications for Lux columns include drug enantiomers from the pharmaceutical sector, chiral pesticide analysis in agrochemical settings, flavour analysis and production from the food industry, fragrance isolation and commercialisation in cosmetics and a range of other chiralchemical raw materials such as intermediates and finished goods.

To complement its comprehensive Lux chiral column line, Phenomenex offers free chiral screening services with greater than 90 per cent success rates from its PhenoLogix application development group, along with over 2,000 chiral applications online that are easily searchable by compound structure or name.

Phenomenex is a global technology leader committed

to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in industrial, clinical research, government and academic laboratories. From drug discovery and pharma development to food safety and environmental analysis, Phenomenex chromatography solutions accelerate science and help researchers improve global health and well-being.

Contact details Jennifer Dahlgren, Dahlgren Communications Phone: (530) 263-6817 E-mail: dahlgrenpr@comcast.net Simon Lomas, Phenomenex, Inc. Phone: (310) 212-0555 Ext. 2267 E-mail: simonl@phenomenex.com Website: www.phenomenex.com

Eppendorf launches new four-litre benchtop centrifuge CENTRIFUGE 5920 R delivers extraordinary high capacity in a very compact and ergonomic product design. It has similar dimensions as competing refrigerated three litre models and yet features a superior capacity of up to 4 x 1,000 mL; thus making it the

ideal instrument for highthroughput applications. It features a powerful state-ofthe-art refrigeration system with advanced temperature management to keep your samples safe.

Contact details M Anthoni Jai Kumar

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Senior Manager - Marketing Eppendorf India Doshi Towers, 4th Floor 156, PHRoad, Kilpauk Chennai – 600 010 Phone: +91 44 42 111 314 / 341 Mobile: +91 938 017 6423 Fax: +91 44 42 187 405 anthoni.jk@eppendorf.co.in

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PHARMA ALLY

Neelikon adds ICP – OES to check metallic impurities NEELIKON HAS added an Inductively Coupled Plasma Optical Emission Spectrometer (ICP – OES) for checking metallic impurities. According to the company, it is the first Indian food colour manufacturer to install ICP – OES. In conventional technology like AAS (Atomic Absorption Spectrophotometer) it is possible to detect elements up to 1 PPB but these elements can be detected as accurately as to 0.01 PPB by ICP – OES. This means the ICP – OES is 100 times more accurate in determining metallic impurities, significantly improving Neelikon’s ability to check incoming raw materials, in-process material

at a time. This covers all the requirements of metallic impurities specified by US – FDA /EU/JECFA (WHO)/Japan/BIS as well as the newly introduced EU Directive 2009/48 for 19 trace elements.

and finished goods.

This assures customers a much superior product performance and also allows Neelikon to meet stringent stan-

dards being set up by world –wide legislation, where minimum levels of metallic impurities are being reduced to ever – lower limits.

By conventional technology like AAS only one element can be analysed at a time whereas

by ICP – OES it’s possible to detect more than 75 elements

Contact details Neelikon Colours Global Tel: +91-22-66661415 (Hunting Lines) Tel: +91-22-66627223 (Direct Line) Mob: +91-9970004010 Fax: +91-22-23523945 / 66626916 Email: satyen@neelikon.com Website: www.neelikon.com www.fluorescentcolours.in www.solventgreen7.in

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

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

Board line: 0120-6651500.

Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com Our Associate: Dinesh Sharma Mobile: 09810264368 E-mail: 4pdesigno@gmail.com CHENNAI Arun J The Indian Express (P) Ltd.

34 EXPRESS PHARMA February 16-29,2016

Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 91 9940058412 Fax: 044- 28543035 Email id: arun.j@expressindia.com BANGALORE G.M. Khaja Ali The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Ext. 108 Mobile: +91 9741100008 Fax: 080- 22231925 Email id: khaja.ali@expressindia.com HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936 Fax: 040 23418675 Email Id: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division

JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com KOCHI Arun J The Indian Express (P) Ltd. Ground Floor, Sankoorikal Building, Kaloor – Kadavanthra Road Kaloor, Kochi – 682 017 Mobile: +91 9940058412 Email id: arun.j@expressindia.com COIMBATORE G.M. Khaja Ali The Indian Express (P) Ltd. No. 205-B, 2nd Floor, Vivekanand Road, Opp. Rajarathinam Hospital Ram Nagar Coimbatore- 641 009 Mobile: +91 9741100008 Email id: khaja.ali@expressindia.com AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015 Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

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

PHARMA ALLY VALUE ADD

Formulation characterisation through particle sizing and rheology Dr Michael Caves, Business Development Manager, Malvern Instruments, gives an insight on how particle size measurements, using a Mastersizer 3000, and rheological measurements, using a Malvern Kinexus rotational rheometer, can be used to fully characterise pharma formulations

TO SUCCESSFULLY develop pharmaceutical formulations it is essential to understand particle size and microstructure parameters that have a major impact on the efficacy and stability of a formulation.

Hyaluronic acid (HA) is a naturally occurring polysaccharide frequently used as a functional ingredient in many topical and subcutaneous anti-ageing treatments such as dermal fillers, which exploit the polymer’s unique viscoelastic properties for effective soft tissue augmentation. When administered subcutaneously, HA builds an elastic network within wrinkles and rhytides to give the skin a plumper and fuller look. Naturally occurring HA has a half-life of less than three days so increasing the durability of the polymer is essential to develop-

ing products with greater clinical persistence and an acceptable shelf life. Increasing both the molecular weight (MW) and degree of cross-linking of the polymer is a proven strategy for improving mechanical strength and extending degradation times. However, these characteristics also impact other properties of the HA such as viscosity and viscoelasticity. Clearly, comprehensive characterisation of these formulations is essential to an understanding of their efficacy, applicability and stability.

Results and discussion Oscillation testing There are many factors that affect the viscoelastic properties of HA dermal fillers including HA concentration, molecular weight and crosslinking degree.

By changing these characteris-

tics the viscoelastic properties, especially the elastic modulus G’, can be engineered for a specific application. Gels with high G’ give higher resistance to deformation and should be more effective as fillers but could be harder to inject and may give more pain. Therefore, strong gels with high G’ may be more

Figure 1. Amplitude sweep data showing elastic modulus (G’) as a function of shear strain

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suitable to use for deeper or more serious winkles. On the other hand, weaker gels with low G’ may be better for fine or light wrinkles found in lips or tear troughs, which are more sensitive, because they would give less pain when injected. The lower modulus may also better match the properties of the local tissue. Of the three HA samples tested it can be said that sample A is the weakest and softest gel and sample C is the stiffest and strongest gel based on results presented in Figures 1 and 2.

Steady shear testing and yield stress determination The results of the steady state shear measurement - shear viscosity measured as a function of shear rate are shown in Figure 3.

The viscosity decreases significantly with increasing shear rate

indicating that the materials are highly shear thinning. Also, the structure of the fillers is so strong that at a low shear rate the viscosity is very high and continues to rise with decreasing shear rate suggesting yield stress or solid like behaviour at rest. This corresponds with observations from oscillation testing which showed a highly elastic gel-like structure. A yield stress indicates that the material will behave like a solid below critical stress but will flow like a liquid above this critical stress.

The magnitude of the yield stress should be related to the structural strength and hence degree of cross-linking and concentration of the gel particles, which should be reflected in G’.

Yield stress can be determined using a number of different tests, however, a stress ramp

Figure 2. Frequency sweep data showing elastic modulus (G’) and phase angle (δδ) as a function of frequency

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PHARMA ALLY η) as a Figure 3. Flow curves showing steady state shear viscosity (η function of shear rate

Figure 4. Stress ramp data showing instantaneous shear η) as a function of shear stress viscosity (η

Figure 5. Tack tests data showing normal force profiles as a function of time during a pull-away test

Figure 6. Particle size distribution (Cumulative volume) for gel particles in dermal fillers

is one of the quickest and easiest ways, where the instantaneous viscosity (not steady state) is measured continuously with increasing shear stress. Stress ramp data for the three HA samples are shown in Figure 4. The peak in viscosity represents the point of yield and the stress value at which this occurs is the yield stress. Sample A has the lowest yield stress (42Pa) and Sample C the highest (55Pa) with Sample B slightly lower than C (53Pa). This is the same order observed in oscillation testing with Sample C the strongest and Sample A the weakest of the three gels. As these gels tend to exists as a collection of covalently cross-linked gel particles (as opposed to a continuous gel network) then the yield stress is associated with the stress required to ‘un-

36 EXPRESS PHARMA February 16-29,2016

jam’ the particles and allow them to move past one another.

Tack testing The normal force profiles as a function of time as the plateplate gap is increased, which is shown in Figure 5. The normal force value is negative because the sample is pulling down on the upper plate due to adhesive/cohesive forces and decays towards zero at failure; the residual force at long times is due to the weight of the retained samples on the upper plate. The peak normal force for samples A, B, and C are 0.35 N, 0.46 N, and 0.54N respectively, which again correlate with the order of G’ and yield stress measurements for the three samples.

Hence, Sample C has the highest degree of tack or cohesivity and Sample A the least.

Particle size Particle size of the gel particles needs to be controlled in order to reduce the extrusion force and associated side effects like pain and bleeding when gels are injected. Therefore, the gels need to be engineered to pass through needles at the appropriate rate with the desired extrusion force. In Figure 6, particle size distribution of gels is shown as a cumulative volume percent. The median size (Dv50) of samples A, B, and C is μm, 425μ μm, and 203μ μm.

480μ Strong gels with high G’ and yield stress values, need to be sized to small particles to be easily injected through the needles. Sample C has the smallest particle size because it has the highest G’ value in the samples.

On the other hand, the sample A has the largest particle size as

it is the weakest gels in the samples (it can be easily passed through the needles). The resulting size will also be related to the extent of cross-linking and molecular weight since highly cross-linked polymers associated with higher values of G’ will be denser and more compact.

Conclusion Rheological properties and particle size of three commercial HA- based dermal fillers were characterised and compared.

The elastic modulus G’ was determined from oscillation testing and those values correlated with gel stiffness and strength (e.g. weak gels or strong gels).

Steady state shear measurements were made to check the viscosity dependence on the shear rate and stress ramp

tests were performed to determine the force required to break down the gel structure i.e. the yield stress. The tackiness of the fillers was determined by measuring normal force profile when the plateplate gap was increasing and correlated with oscillation, and yield stress data. Furthermore, the particle size of gels was measured because the size affects extrusion, and this was found to correlate with rheological data also.

In conclusion, the rheological properties and particle size of HA based dermal fillers are essential parameters to determine the performance (e.g. easy delivery, extrusion force, injection, resistance to deformation, pain reduction) and application (e.g. fine or deep wrinkle, facial contouring) of these products.

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POWDER FILLING MACHINE (load cell based)

GARNULEFIL MACHINE

OUR OTHER PRODUCTS 1. Automatic Double Head Augerfiller machine To fill dry syrup powders and similar powders.

2. Automatic Microdozer machine with bung feeding and pressing units.

To fill dry injectable powders from 100 milligrams to 3 grams. Special attachments available to fill from 25 milligrams.

3. Electronic Tablet Counting and filling machine.

Tablets & capsules of any size and shape. No change parts required.

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Pharmaceutical Formulation Efficacy, Stability and Applicability Developing a pharmaceutical formulation with appropriate efficacy, stability, and applicability is one of the key stages of drug development. Malvern’s formulation development platform optimises the bioavailability, shelf-life and usability of your product – increasing quality and reducing waste.

Particle Size

Shelf-life

Applicability

Particle size controls the dissolution characteristics of tablets and delivery uniformity in suspensions – Malvern’s Mastersizer 3000 (pictured) and Zetasizer systems give accurate, precise and repeatable particle size characterisation

Comprehensive understanding of stability reduces the cost of batch expiration - Malvern’s Zetasizer ZSP and Kinexus range are used to assess the electrostatic and kinetic stability of formulations

Flow characteristics define the applicability of a formulation - Malvern’s Kinexus (pictured) range has the versatility to assess the flow properties of a formulation under applicationrelevant conditions

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PHARMA LIFE INSIGHT

The leadership gap

AMOGH DESHMUKH, Member, Key Leadership Team, DDI India

Amogh Deshmukh, Member, Key Leadership Team, DDI India, in the first of a series of articles, talks about leadership challenges in the pharma sector and the way forward

like pharma and IT are going to face many challenges but have fewer leaders to deal with this change. Hence, organisations might want to start developing leaders now or look at hiring talent from outside.

DDI analysed assessment data of 200+ senior/mid-level executive across various pharma companies over the

last few years. In context of the phenomenal growth that the pharma sector would experience in the next 10 years and the findings of GLF research, we wanted to review if leaders are equipped to manage this change and deal with the pace of growth.

The driving force

Leaders in the pharma sector are generally good task masters. They are very result focused, quick at decision making and excellent at marshalling large teams.

Action orientation is what one might say. Itâ&#x20AC;&#x2122;s normal to find strengths in such tactical and operational competencies. In most cases, this is a game of

Increase

Leader quality and bench strength trends by industry Stay the course

Eager and waiting impatiently Financial banking/ insurance

Change in Bench Strength 2011-2014

Retail

Business Service

Energy

Headed in the wrong direction

Many challenges few leaders

Manufacturing Pharmaceuticals

IT

Decrease or No Change

T

he sunrise industry, the recession proof industry it is called by many names and it has been growing from strength to strength over the last few years. The Indian pharma industry has grown to become the sixth largest market in the world. All analyses suggest that the Indian pharma industry will grow to $55 billion by 2025. This is almost a threefold growth from what it is at present. With planned investments of around $200 billion by 2024 and 100 per cent FDI in medical devices, we can expect some serious action. With the pace at which India is dominating the global exports, all indicators suggest that there is a lot of action expected in this industry in the next few years.

This is a very capital intensive industry, and also a large employer of workforce. The Planning Commission expects growth in employment to cross 20 lakhs by 2020 in this industry from its current levels of eight to 10 lakhs and these estimates are associated with only direct employment.

One can only say that by 2025 this number might be in the corridors of 25 lakhs. This tells us that we will have to accelerate the growth of leaders faster than ever before.

In 2014-15, we released our Global Leadership Forecast (GLF) study, a survey that looks at several talent management practices and trends in leadership succession/ bench strength globally. We found that globally, industries

Healthcare providers

Decrease or No Change

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Change in Leader Quality 2011-2014 Increase

numbers and leaders have grown from within the organisations. churning them day in and day out. This makes them very good at managing and maneuvering their networks internally as well and managing large size teams. They are habitual to stay close to grow realities which allow them to gather necessary information quickly for taking operational decisions as and when necessary. This behaviour might come naturally to our leaders of the current world as they very ambitious and go-getters.

Their burning desire to succeed allows them to drive numbers very aggressively.

The sad news is that many of these leaders turned out to be very inward-looking and very task-focused. To an extent you might label them as tactical leaders. They lacked the ability to take organisation from strength to strength when the organisation might demand 2X or 3X growth. This builds pressure on the top management as we find this layer of leaders lacking strategic depth and inadequate to execute strategy well. Enterprise level competencies like financial acumen (87 per cent), entrepreneurship (54 per cent) and building organisational talent (45 per cent) were found weak in a large number of these leaders.

When we club the above with some of the competencies needed for the future such as driving change (35 per cent), business savvy (37 per cent) and establishing strategic direction (32 per cent), it

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suggests that if organisations want to grow at a rapid pace then this level of leadership needs immediate exposure in these areas to develop them.

Mind you, these are slightly hard competencies to develop.

There is no pill or a patch that can give a quick fix. Such competencies need to be developed through experiential learning and personal mentoring by top management of the organisations. We have been hearing of mergers and acquisitions (M&A) in this space over the last few years. We hear of patents expiration in the generic drug market and many of these drugs capture market share worth millions and billions of dollars. In the next few years, imagine if these leaders have to be in the forefront in driving change.

You might find them struggling to provide direction, or stretching the boundaries for their teams.

For many leaders this might come as a shock as many interpret meeting numbers as good sense of business or financial acumen. However, their past successes can be a limitation for their future growth. As Marshall Goldsmith, a renowned American leadership coach said, “What got you here won’t get you there.” Leaders might become victims of their own success.

DDI’s research suggest that leaders need to have few strong qualities within themselves such as being a good listener and being receptive to feedback.

Another important area of concern we saw as with respect to understanding their customer. We found a slight confusion among the leaders with reference to the interpretation of ‘who is my customer.’

Few leaders view it from the lens of doctors as customers, a few leaders view it through the eyes of the pharmacists’ and stockists’ perspective as customers but very few see it from the patients’ lens. With improvements in technology and rapid growth of mobile apps which provide information on medicines at finger tips, end users are aware of

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Strength competencies

Percentage of leaders

Cultivating networks

92%

Leading teams

89%

Passion for results

86%

Operational decision making

83%

(N = 55 to 180)

Competencies needing development

Percentage of leaders

Financial acumen

87%

Entrepreneurship

54%

Building organisational talent

45%

Customer focus

44% N = 140 to 211)

Competencies to watch out for

Percentage of leaders

Business savvy

37%

Leading change

35%

Establishing strategic direction

32%

(N = 55 to 180)

the different types of drugs available in the market and their alternatives. Whether it is in generics, branded drugs, preferred or non-preferred drugs, unless leaders start putting the patient at the centre of their plan they might miss the point. The whole education process might see a ‘C’ change; communication might not be just to doctors but also to the patients. Leaders will have to deal with change in a lot of ways.

I was trying to see how we can tap these leaders’ strengths and development areas and I found this research from DDI very relevant. DDI’s research, ‘The New Reality of Mid-Level Leadership’ brings out the same challenge in a slightly different manner.

When we surveyed middle level leaders, they told us that they place primary emphasis on the ‘here and now’. As you can see from the adjacent chart they are spending the majority of their energy on resources, execution, and tactics needed to get things done today, and very little time and focus on future-oriented things like the need to make change, to innovate, to think more

broadly and consider talent requirements in the future to drive growth. I will not blame them. DDI’s GLF 2014-15 suggests that organisations have built their systems in such a way that leaders are forced to manage people and tasks; not to really interact with people.

Thus, the ‘here and now’ focus.

The war for talent is only going to get steeper. We might have good doers and actionoriented leaders for today.

They might be very tactical and operation-focused. Their approach is like being problem solvers and they might be able to optimise the resources available with them to achieve the same. But certain futuristic competencies which can make them enterprise level leaders are weaker areas at this point. They might want to balance their approach between the immediate or shortterm and long-term focus.

While the leaders are task-focused they might want to think of how to put long-term processes in place or introduce best practices and focus on adhering to them. Leaders will have to broaden their mindset to think beyond the functional/operational. They might want to look at some larger levers like market drivers, customer trends, etc to make informed decisions.

Leaders might be good at leading large teams, but they also need to look at development of team members by building their skills over a period of time.

The wakeup call All external indicators suggest that pharma industry will continue to grow. But, are we over-emphasising on capital investment and topline growth?

We believe that ‘the organisation is as strong as its weakest link’. With no development or poor development focus we will not have an adequate number of leaders to deal with this growth. As I said earlier, there is no pill or a patch that can fix this issue. Organisations need to develop able leaders over a period of time.

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