Express Pharma (Vol.12, No.19) August 1-15, 2017

VOL. 12 NO. 19 PAGES 84

www.expresspharmaonline.com

Interview

Jorge A Coarasa, Senior Economist (Health), World Bank

1-15 AUGUST 2017, ` 40

CONTENTS Vol.12 No.19 August 1-15, 2017

INDIAN PHARMA INC’S TRYST WITH DESTINY MARKET

Chairman of the Board Viveck Goenka

The evolution of the Indian pharma industry since independence into a powerhouse supplying 20-24 per cent of the global demand for generic drugs | P20

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

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National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

P15: PRE EVENTS analytica Anacon India and India Lab Expo to be held in Hyderabad

PHARMA ALLY

INDIA HAS RECOGNISED THE NEED FOR STRONG INNOVATION POLICIES

RESEARCH

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P35: REPORT Pharma, medical and biotech witness 290 deals worth $89.9 bn in second quarter: Report

P77: BOOK REVIEW

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The Act That Wasn't

PHARMALYTICA SPECIAL

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EDITOR’S NOTE

India Pharma Inc's tryst with destiny continues s we mark our 71st Independence Day this August 15, how far have we progressed on the medicines security front? The commonly accepted definition of food security is when “when all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life.”

Substitute food for medicines and it’s clear that while we have made commendable progress, we are still far from complete independence on the medicines front. Until we can secure physical and economic access to quality medicines for all Indians, India Pharma Inc will have fallen short of expectations.

For instance, we are still dependent on other countries for many of our intermediates and APIs. Any tension at our national borders has us staring in the face of shortages. Of course, today we are much more organised and have back up plans in place. So while it will call for planning and strategising, we will not be in the same dire position as during the Beijing Olympics.

Another instance is the flashpoints on intellectual property rights (IPR), patents and copyright issues. For example, India is a long time member of the USTR priority watch list. The Regional Comprehensive Economic Partnership (RCEP) negotiations in Hyderabad too could force the Indian pharma industry into a corner.

But the journey to become the pharmacy of the world has made pharma companies from India more resilient. Companies are becoming adept at changing strategies. If Prime Minister Modi's Make In India defines strategy in the domestic market, then President Trump's Make America Great Again chant has the same pharma companies setting up and acquiring overseas manufacturing units based in the US. In the first of two Independence Day special issues, the Express Pharma issue dated August 1-15 has articles from industry insiders trace the milestones of India's pharma industry in the past seven decades. Highlighting the regulatory milestones, Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates ends on a hopeful note, saying that 'the silver lining among these clouds is that the entrepreneur-driven Indian pharma industry is bound to ride on these challenges and emerge as a global pharma superpower in next 10 years, if not through 'Make in India' by 'Make overseas' route, since Indian pharma is now mastering the international regulatory compliance standards.'

Giving a regulator's perspective, Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO

A

Until we can secure physical and economic access to quality medicines for all Indians, India Pharma Inc will have fallen short of expectations

comments that from the days when syrups were stirred with wooden paddles and filtered through felt bags, with no thought of contamination, there is a realisation today that making and distributing poor quality medicines leads to loss of credibility for everyone, both public and private healthcare and the manufacturers.

And to round off the perspectives, we have a profile of one of India's oldest pharma companies, Indoco Remedies, tracing its evolution in tandem with India Pharma Inc. The country has had help from various global regulatory agencies and organisations. These influences continues to date and rightly so, as rules need to be harmonised with global practices. Thus Jorge A Coarasa, Senior Economist (Health), World Bank spells out how his organisation is partnering with the Biotechnology Industry Research Assistance Council (BIRAC) to make India’s strategy of ‘Decade of Innovation 2010–20’, a reality. World Bank's 'Innovate in India for Inclusiveness' project will provide grant funding to a consortia of private, public, and academic institutions, led by cutting-edge institutions in their respective field, to accelerate the development of low-cost, select vaccines, biopharmaceuticals, diagnostics, and medical devices that address public health priorities in India.

It is hoped that this project will be a big step towards achieving self sufficiency in these areas.

These global collaborations serve another need to harmonise our regulations. This could be seen as interference in our policies, to prevent safeguards in line with our public health needs. For instance the backlash to India's first and so far only compulsory license for sorafenib is still cited as an example of India's weak laws on IPR. However, India has no choice but to harmonise its regulations if it wants domestic pharma companies to compete globally. For instance, India's track and trace requirements set by the Directorate General of Foreign Trade (DGFT) are substantially different from key markets like the US and EU. For example, India has mandated specific numbers that must be used as the initial digit of a Global Trade Item Number (GTIN). Global standards implemented in dozens of countries allow the manufacturer to determine the initial digit. Industry sources have pointed out that this inconsistency creates labelling confusion and causes system errors, resulting in the distribution of Indian products being stopped.

So India's pharma industry faces it own 'tryst with destiny'. While regulators will be a crucial link to decide which path they will choose at this juncture, pharma companies from India today have the heft, size and scale to make their own destinies. Watch out for the second part of the Independence Day Special in the August 16-31 issue.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

India has recognised the need for strong innovation policies Recently, World Bank has announced its new project 'Innovate in India for Inclusiveness', to help India develop an innovative biopharmaceutical and medical devices industry and promote industry-academia dialogues. Jorge A Coarasa, Senior Economist (Health), World Bank divulges more details about the project, in an interaction with Usha Sharma

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When is the World Bank initiating ‘Innovate in India for Inclusiveness’ Project?

From July, Biotechnology Industry Research Assistance Council (BIRAC) is expected to call for proposals from public-private-academia consortia for grants towards different activities the project is supporting.

Elaborate three different components of the project and how are you going to execute it?

The first component of the project will support activities aimed at strengthening the pilot-to-market innovation ecosystem. The interventions under this component will be targeted at addressing critical gaps in infrastructure, human capital, and technology transfer that have been identified as weak areas in the pilot-to-market innovation ecosystem for biopharma and medical devices.

The project will not address the overall regulatory and institutional framework for biopharma and medical devices in India, which has already undergone significant reforms in the last three years that improved its robustness, but will have targeted interventions within that framework to improve areas where gaps have been identified, which is in the areas of clinical trials and technology transfer.

It will provide grant funding to support the creation of centres of excellence for validation, early stage bio-manufacturing, clinical development, training, and technology transfer.

Funding will be used to procure specialised equipment, services, and technologies required for the different stages of the pilot-tomarket process.

The project will provide grant funding to a consortia of private, public, and academic institutions, led by cuttingedge institutions in their respective field, to accelerate the development of low-cost, select vaccines, biopharma, diagnostics, and medical

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devices that address public health priorities in India. By extending financing to a consortium, the project hopes to foster a more collaborative research and development (R&D) environment which leverages the expertise of local and international players from

both the public and private sectors. Additionally, having a consortium presents an opportunity to link micro, small, and medium enterprises (MSMEs) in the field with larger companies.

Finally, the products directly supported by the

project will be those that address public health priorities, have market potential, and are already in the critical validation to early bio-manufacturing stages of product development. In addition to reflecting the lower cost of development in

lower market prices, the recipients of grants under this component will commit to delivering agreed quantities at agreed prices to the public health sector in India. Finally, any technologies developed in the process of product development will be treated as

MARKET non-proprietary and will be accessible to other users.

How will this project encourage industryacademia iinteraction and help them in building innovation research capacities for developing affordable healthcare products?

Industry associations, academic institutions, and public sector undertakings have been convened by BIRAC to identify and prioritise both the gaps and the products targeted by the project.

Grants provided by the project will be leveraged to bring together top Indian institutions with cutting-edge international players including private firms, individual experts, and contract research organisations as well as universities and other research centres. These international partners will be engaged through knowledge transfer agreements, technology licensing and acquisition, and other innovative mechanisms tailored to each activity. The grant-based design of the project leverages market demand by allocating performance-based funds through open, competitive calls for proposal with transparent eligibility and selection criteria.

Sustainability has been a key criterion in the design as the project aims to build an

ecosystem for the future.

How are BIRAC and World Bank working towards creating a progressive ecosystem in biopharma and medical devices sector?

India has recognised the need for strong innovation policies, particularly in support of the biopharma sector. India’s strategy, ‘Decade of Innovations 2010–20’, aims at strengthening innovation capacities by increasing gross expenditure on R&D to two per cent of gross domestic product (GDP) by 2020. The Make in India initiative, an ambitious countrywide programme launched in September 2014 to encourage manufacturing, identifies the pharma, biotechnology, and medical device industries as priority sectors and aims at addressing a number of policy challenges and improving the business environment to foster India’s competitiveness.

BIRAC has supported 539 companies (mainly start-ups and MSMEs) that are implementing 360 projects, with funding support of over $100 million and commitments of over $160 million from the private sector. These projects have delivered 26 affordable products and 19 new technologies in addition to creating 53 new intellectual properties (IPs).

This project will further enhance BIRAC’s work in

transforming the biopharma and medical devices industries in India. The World Bank will leverage its experience in financing and supporting the implementation of innovation, competitiveness, and public health projects to help the GoI unlock India’s potential for increased innovation.

Drawing from global best

India has recognised the need for strong innovation policies, particularly in support of the biopharma sector practices adapted to the strategic and institutional context of India, the design of the project is based on a holistic approach to productdriven innovation in the biopharma and medical device industries. The project will help filling up financing, infrastructure/technology, and human capital gaps where there is limited public or private resources. These efforts are expected to

provide strong demonstration effects and to crowd-in additional private sector financing and participation in the sector going forward.

When the industry projects that Indiais capable of tackling a host of diseases that plague the world, why is investment in research activity so low?

Access to private capital (venture capital [VC], private equity, and so on) is extremely limited at this stage due to the perception of high risk. While a few large companies have the means to fund product development and scale up, these investments can be prohibitively costly for smaller firms, and network and market financing failures can prevent their acquisition.

Globally, substantial government grants are available for scale-up funding, especially in the European Union, the US, and Asian countries such as the Republic of Korea, but the dearth of such options in India affects the competitiveness of the industry and the ability of critical products to reach the market in a reasonable time frame and at an affordable price.

India has strong and welldeveloped capabilities in the pre-validation and large-scale manufacturing stages where the industry’s research and the bulk of private investment are focused; however, critical technology and knowledge

!

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gaps exist in pilot-to-market stages of the product development lifecycle. Firms, and in particular, micro, small, and medium enterprises (MSMEs), lack access to technology and equipment tailored to specific needs across poorly developed stages of drug development, such as basic and applied research, clinical trials, and validation. While infrastructure, technology, and human capital are critical to successful innovation, the levels of investment required and appropriation problems make it prohibitive for individual firms to pursue these investments. In countries that have been successful in building effective innovation ecosystems, partnerships among government, the private sector and academia have eased access to these shared facilities and public goods.

Research shows that relative to other regions, a much larger share of innovation in South Asia takes place in-house, limiting productive collaboration across firms and possibly explaining high rates of imitation instead of radical innovation. Cooperation to strengthen interactions and linkages across the various stakeholders in innovation processes is an essential pillar in the innovation ecosystem. u.sharma@expressindia.com

MARKET PRE EVENTS

analytica Anacon India and India Lab Expo to be held in Hyderabad 250 plus exhibitors from 11 countries will take part in the event ANALYTICA ANACON India and India Lab Expo will be held in HITEX, Hyderabad from September 21-23, 20-17. It will bring together internationally renowned exhibitors, consultants, business experts and key government officials on one common platform to discuss global best practices and seek solutions to some of the most pressing challenges related to the industry.

In 2017, the highlights of the event are a sprawling exhibition space of 10,500 sq mtr, 250 plus exhibitors from 11 countries, 7,300 trade visitors, country pavilions from Germany and China and buyer seller meetings. analytica Anacon India and India Lab Expo will focus on innovative and applied product and system solutions for laboratories in the industrial, research and science sectors. Leading buyers, decision-makers, scientists and entrepreneurs from around the globe will be present to get relevant information about the latest developments during the three-day event.

In 2016, analytica Anacon India and India Lab Expo highlighted the huge potential of the Indian laboratory technology, analysis and biotechnology market. The two trade fairs confirmed themselves as the leading industry platform on the Indian subcontinent.

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MARKET

Second edition of Healthcare Senate to be held in Hyderabad The theme for the second edition is ‘Building a future-ready healthcare sector for India’ AFTER THE success of the inaugural edition of Healthcare Senate last year, Express Healthcare is gearing to host the second edition of the event. This time, the theme is ‘Building a future-ready healthcare sector for India.’

The summit will be held at Novotel Airport, Hyderabad, from September 7-9, 2017.

Thought leaders from the healthcare industry will congregate to exchange insights, share innovative ideas and build healthy connections.

The event will address pivotal topics through panel discussions: They would include: ◗ Overcoming obstacles in business expansion: In this session, the panel will discuss strategies, infrastructure required and resource development needed for expansion of businesses. ◗ Healthcare policies: Are they making or breaking the sector?: Association heads of AIMED, NATHEALTH, NABH, AHPI, NPPA and government officials will discuss the impact of pricing policies, quality codes etc., on the sector. The panel will also deliberate on the need for an Af-

costs by addressing people, process, and technology components within their hospitals.

The other topics which would be addressed at the event will be: ◗ Building an effective supply chain inventory management system ◗ Developing a physician leadership programme within hospitals ◗ Effective brand building for business success ◗ Understanding medical laws: a must for healthcare providers ◗ Medical tourism: An ocean of opportunities for India ◗ Evolving role of hospital pharmacies in India fordability Act in India. ◗ Fighting the antibiotic apocalypse: Infection control experts, hospital administrators, pharma companies, NABH representatives will discuss ways to control the increasing burden of antibiotic resistance ◗ Ensuring cost efficiencies within capital intensive department: Radiology

department heads of hospitals, imaging diagnostic promoters, Cath lab heads, OT heads and hospital CFOs will discuss how to reduce operating costs of these capital intensive departments to make the business profitable. ◗ People first: Hospital CEOs, promoters, nursing heads, HR heads, manage-

ment consultants will discuss on building talent and capabilities for the future.

Revenue cycle transformation- A must for healthcare organisations: Hospital CAs, financial experts, healthcare CFOs, COOs or CEOs and PE investors will discuss on ways and means to increase their net revenue, accelerate cash flow, and reduce

To register, click : http://healthcaresenate. financialexpress.com/ registeration/ or Contact Vinita Hassija Mob: 9820590053 E-mail: vinitahassija@gmail.com

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MARKET DEAL TRACKER

Pharma industry records 53 deals worth $9.4 billion in June 2017 JUNE 2017 DEAL ACTIVITY

Private equity firms dominated the deal activity in the pharma and healthcare sector in June 2017 PRIVATE EQUITY (PE) firms were aggressive in deal activity in June 2017 in the pharmaceutical and healthcare industry, particularly the contract services providers. The industry recorded a total of 53 deals worth $9.4 billion in June 2017, with PE activity accounting for 87 per cent of the total

Source: GlobalData

MARKET

Source: GlobalData

value. One of the major transactions in June 2017 includes the proposed acquisition of Parexel International by PE firm Pamplona Capital, for $88.1 per share or approximately $5 billion.

Pacific equity and Carlyle’s proposed acquisition of iNova Pharma from Valeant Pharma for $930 million, and Carlyle Group and GTCR’s proposed acquisition of Albany Molecular Research for approximately $922 million are a couple of other transactions that contributed to the PE deal activity in June 2017.

Deal Date

Acquirer (s)

Target

Deal Value ($ m)

06/20/17

Pamplona Capital Management LLP (UK)

Parexel International Corp (US)

5000

06/08/17

Pacific Equity Partners PTY Limited (Australia); The Carlyle Group L.P (US)

iNova Pharmaceuticals (Australia) Pty Ltd (Australia)

930

06/06/17

GTCR LLC (US); The Carlyle Group L.P (US)

Albany Molecular Research Inc (US)

922

06/26/17

AGIC Capital (China)

The Ritedose Corp (US)

800

06/26/17

Advantech Capital Partners Ltd; C-Bridge Capital Partners LLC; SAIF Partners; Vivo Capital

Sinovac Biotech Ltd (China)

401.8

Deal Date

Acquirer (s)

Target

Deal Value ($ m)

06/21/17

Flagship Pioneering Inc

Rubius Therapeutics Inc (US)

120

VC investments continue to be stable in June 2017

06/22/17

BDC Capital Healthcare Fund; Celgene Switzerland LLC; Fonds de solidarite FTQ; MPM Capital Partners; Versant Venture Management, LLC

Repare Therapeutics Inc (Canada)

68

06/01/17

New Leaf Venture Partners LLC; Redmile Group LLC; Sphera Global Healthcare Fund; Undisclosed Investor(s); Viking Global Investors, L.P

Deciphera Pharmaceuticals LLC (US)

52

06/01/17

Astellas Venture Management LLC; Atlas Venture; Cambridge Innovation Capital Plc; Longwood Fund; Novartis Venture Funds; SR One Ltd; SV Life Sciences Advisers LLP; Vertex Ventures

Bicycle Therapeutics Ltd (UK)

51.4

06/21/17

Apple Tree Partners; Undisclosed Investor(s)

Syntimmune Inc (US)

50

The venture capital (VC) market recorded an increase in average deal size with 71 deals worth $1.1 billion in June 2017, compared to 88 deals worth $1.1 in May 2017.

Flagship Pioneering’s US$120 million investment in Rubius Therapeutics, a biotechnology company, is one major VC deal reported in June 2017.

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MARKET EVENT BRIEF AUGUST TO SEPTEMBER-2017 3

PharmaTech Expo 2017

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. The focus will be on pharma machinery and equipment manufacturing

sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event.

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INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific,

analytical and biotechnology sector will see international as well as Indian manufacturers and distributors.

Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science &

Technology, Government of India.

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cover )

INDIA PHARMA INC’S TRYST WITH DESTINY The evolution of the Indian pharma industry since independence into a powerhouse supplying 20 per cent of the global demand for generic drugs

20 EXPRESS PHARMA August 1-15, 2017

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THE MAIN FOCUS

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cover ) SPOTLIGHT

Trial by fire Born just a week after India gained independence, Indoco Remedies has witnessed and been a part of the trials and triumphs of the country's pharma sector for the last seven decades. Now, as we gear up to celebrate the 71st anniversary of the day which marked the end of colonial rule in India, the company has grown steadily to become a well-known entity in the Indian pharma sector. By Usha Sharma

F

ounded by late Govind Kare, Indoco Remedies was set up to import pharma formulations from Europe and distribute them in the Western India.

However, the road ahead for the fledgling company in a newly liberated nation was no cake walk. Though it had a small pharma unit in Thane, Mumbai, most of Indoco's operations were handled out of Goa which was in the midst of its struggle for liberation.

This made it very difficult for the company to manage its operations.

Goa's independence in 1961, ending Portuguese rule on the Gomantak heartland, proved to be a blessing to the company as well as it served to stabilise its operations. In 1963, when Suresh Kare, the founder's son took charge as the Managing Director, the company's annual turnover was around ` 3 lakhs and had 30 employees on payroll, a loss-making entity.

The turnaround It was now up to the new leader to turn the company's fortunes and make it a profit-making venture. An uphill task in the business environment which existed in the country at that time. However, Suresh proved his mettle with hard work and

22 EXPRESS PHARMA August 1-15, 2017

Indoco Field Force in 1976. Now the strength is around 3000

business strategies that gradually put the company on the growth track. The government's decision to favour indigenous players over the MNCs who had dominated the industry since independence also spurred the growth trajectory of the company.

The passage of the Indian Patent Act in 1970, which brought in the regime of ‘Process Patents’, the export initiatives taken by the industry in 1990s, liberalisation of

the economy in 1991, opened up new growth avenues for domestic players. Indoco, helmed by an able leader was able to capitalise on the opportunities and emerge as a significant entity in an expanding landscape.

Charting a success story After successfully spearheading the company as Chairman and Managing Director for five decades, in 2012, Suresh Kare handed over the management reigns of Indoco to the third

GROWING TURNOVERS 1980:

` 1 crore

1989:

` 10 crore

1999:

` 100 crore

2016:

` 1000 crore

generation - Aditi Kare Panandikar as Managing Director and Sundeep V Bambolkar as Jt Managing Director.

Speaking on the company's strategies for growth, Kare Panandikar says, “Unlike most Indian pharma companies who commenced their business with APIs and then forward integrated into formulations, Indoco started with finished dosages and then forayed into API business as a backward integrated initiative to support its captive demand. Our employee strength grew gradually and today boasts of around 6000 employees, including skilled scientists. Today, the company is present in 55 countries and has crossed sales of $165 million.”

In 1974, Indoco commissioned its manufacturing unit at MIDC, Andheri. Today, the company has nine manufacturing facilities, six of which are for Finished Dosage Forms (FDFs) and three for APIs, supported by state-of-the-art R&D Centre and a CRO facility. In 2003, the company’s manufacturing facility in Goa received its first UK-MHRA approval and today, all its facilities have been approved by regulatory bodies like the US FDA, UKMHRA, TGA-Australia, MCCSouth Africa, etc.

( Kare-Panandikar says, “Thanks to the strong infrastructure and a good customer base across the world, export business has been growing steadily and accounts for almost 45 per cent of Indoco’s total revenues. We have profit sharing arrangements with major generic companies in the US and have a large pipeline of products under approval in the niche ophthal segment. At Indoco, the regulated market product pipeline is selected very carefully and the company started preparing for product registrations in the injectable category for the next growth wave.”

in 2016 at Baddi. The AnaCipher CRO facility is spread over 30,000 sq ft and staffed by experienced professionals providing clinical trials solutions, including bioavailability and bioequivalence (BA/BE)/Phase /Phase II studies for pharma companies. With the smooth integration of these facilities, the company is now completely integrated with sufficient capacity to cater to demands from its customers and will remain a preferred partner, offering complete solutions to generic companies worldwide.

The above acquisitions show the far-sightedness of the management to invest in viable projects and boost the revenues through in-organic growth.

Explaining the rationale behind adopting this route to grow, Kare Panandikar stresses, “Besides, the M&A activities give the management a better insight in studying such opportunities and learning the art of integrating new business in the mainstream after acquisitions.

M&As for progress Due to the stress on manufacturing, increased regulatory hurdles and rising competition, the growth of the pharma industry has reached a saturation point. Indoco realised that organic growth alone may not be enough to reach the objectives set and inorganic growth through acquisitions is the need of the hour.

Indoco, though has primarily relied on organic growth, also has a track record of acquisitions. These acquisitions provided opportunities to diversify in different therapeutic segments and business areas. To start with, Indoco Remedies acquired Warren Pharmaceuticals Ltd (WPL) and Warren Laboratories Ltd (WLL) in the year 1999. Both these companies were operating as 100 per cent subsidiary companies of Indoco after acquisition and were merged with Indoco in 2002, into separate domestic

THE MAIN FOCUS

A strong brand Indoco Management Team

marketing divisions. These companies were majorly operating in ophthalmic and dental therapeutic segment areas. Immediately after the acquisitions, Indoco used its acquired expertise to build a state-ofthe-art facility to manufacture sterile products.

To enhance the company’s presence in the API segment, Indoco acquired an API company, Lanova Chem India,

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located at Patalganga. In the year 2004, Indoco acquired ‘Karvol Plus’, from Solvay Pharma India, to strengthen its respiratory therapeutic segment.

Recently, Indoco had two major acquisitions. The company acquired a Clinical Research Organisation (CRO) facility at Hyderabad from Piramal’s in 2015 and a solid dosage facility from Micro Labs

The brands built by Indoco over a period of time have today become recognised household names, viz., Febrex Plus, Cyclopam, Cital, Sensodent, ATM, Oxipod, etc. , Indoco’s domestic business generates more than 70 million prescriptions annually from around 4,65,000 doctors belonging to various specialties. Indoco has nine domestic marketing divisions with a strong brand portfolio in various therapeutic segments, like respiratory,

anti-infective, dental care, pain management, gastro-intestinal, ophthalmic, cardiovascular, anti-diabetics, anti-obesity, etc.

Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent-KF, Karvol Plus, Glychek, Tuspel Plus, etc.

Moving forward Indoco has also launched divisions such as AnaCipher and Xtend Industrial Designers & Engineers. The company’s international business is expected to grow speedily as ANDAs would be commercialised at regular intervals.

EU approval of newly acquired solid dosages manufacturing facility at Baddi will also pave the way for higher growth in European market. While surging ahead in the regulated markets, Indoco is also consolidating its position in the emerging markets through active brand promotion. Robust pipeline in multiple dosage forms is expected to help the company expand its international business.

She sums up, “Expertise in research and development, backward integration in API in select molecules, own CRO setup, excellence in finished dosages manufacturing and a strong customer base will ensure consistent growth in the company’s domestic as well as international business.”

Thus, Indoco has been a constant companion in India's progress path and is living up to its motto of ‘Constantly Evolving and Consistently Excelling’. u.sharma@expressindia.com

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cover ) EVOLUTION OFTHE INDIAN PHARMA INDUSTRY 1947

50 19 s

✦ Dominated by western MNCs. Controlled 80 90% of market, mainly through importation.

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✦ Foreign companies held the patent for 99% of all pharma products under patent in India. ✦ Domestic Indian drug prices were among the highest in the world.

✦ Import-dependent until government policies stressed self-reliance through local production. ✦ Five state-owned pharma companies were set up to grow the domestic market

✦ Indian Patents Act 1970 and Drug Price Control Order of 1970 gave a big fillip to Indian manufacturers. ✦ A generation of scientist-entrepreneurs took this opportunity to set up companies which have emerged as pharma giants

80 19 s

90 19 s

✦ Indian pharma companies developed R&D base and moved up the value chain. ✦The indigenous sector gained considerable portion of the market. ✦ In late 1980s, Indian pharma firms started eyeing overseas markets.

✦ Production and formulations of bulk drugs grew substantially. ✦The Trade Related Intellectual Property Rights (TRIPs) agreement brought India's patent regime in harmony with the WTO regulations. ✦ Free imports, foreign investment and technological superiority became the buzzwords

TURNOVER OFTHE INDIAN PHARMA INDUSTRY The pharma industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharma formulations, chemicals, tablets, capsules, orals and injectables

DID YOU KNOW?

Established in 1954, Hindustan Antibiotics Ltd (HAL) was the first public sector pharma company in India. It was set up with help from WHO, UNICEF

India had entered independence with the patent system of the British colonial masters, enacted in 1911

The first pharma company in India, Bengal Chemicals was founded by Acharya Prafulla Chandra Ray, the Father of Indian Chemistry, in 1901

Roche was the first company in India to receive a patent under the product patent regime.

It was granted for Pegasys (peginterferon alfa-2a), used in the treatment of hepatitis C, in March 2006 Sources: http://www.jpsbr.org/ https://www.ibef.org https://www.in.kpmg.com http://pharmaceuticals.gov.in/document/annual-report-2016-17

24 EXPRESS PHARMA August 1-15, 2017

1990 $1 BILLION

1952 `32 CRORES

( THE GROWTH SAGA 00 20 s

Growing generics market The generics market stood at $26.1 billion in 2016 from $21 billion in 2015. India’sgenerics market has immense potential for growth

One of the highest exports India accounts for 20% of global exports in generics. In FY16, India exported pharmaceutical products worth $16.89 billion, with the number expected to reach $40 billion by 2020

✦ Indian pharma companies take the M&A route to increase product portfolios and market footprint. ✦ 100 % FDI in medical devices and New Drug Pricing Control Order

Among fastest growing industries The country’s pharmaceutical industry is expected to expand at a CAGR of 12.89 % over 2015–20 to reach $55 billion

LAWS OF THE LAND

✦ The pharma sector started attracting high FDI inflows. ✦ India became a major manufacturer of branded, generic and branded generic medicines with a strong export pipeline. ✦Enactment of the Patent (Amendment) Act, 2005 changed the protection regime in India.

Rapidly growing healthcare sector Indian healthcare sector, one of the fastest growing sectors, is expected to advance at a CAGR of 17% to reach $ 250 billion over 2008–20

Leading pharma producer Indian pharmaceutical sector accounts for about 2.4% of the global pharma industry in value terms and 10% in volume terms

10 20 s

2015 $30 BILLION

Indian Patent Act, 1970 Encourages the indigenous pharma industry in India and to ensure that the citizens could afford the drugs. Only process patents were allowed until amendment in 2005 to implement product patent regime in India

THE MAIN FOCUS

Ranked 5th in terms of attracting FDI Pharma sector in India attracted 5 % of the total FDIs into India from April 2000 to September 2016 Cumulative FDI inflows worth $14.49 billion were made during April 2000 to September 2016

Source: BEF Report 2017 www.ibef.org

Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 Regulates import, manufacture, distribution and sales of drugs in India. Ensures drugs and cosmetics sold in India are safe for consumption and conform to standards set by Government Drugs and Magic Remedies (Objectionable Advertisements) Act in 1954 Ensures adequate control over the advertising of drugs in India. Prohibits advertisements of drugs that claim to have magical properties.

Narcotic Drugs and Psychotropic Substances Act, 1985 Provides stringent provisions to control and regulate operations of narcotics drug or psychotropic substance. Prevents and combats abuse of illicit traffic in narcotic drugs.

Drug (Prices Control) Order, 2013 Empowers the National Pharmaceutical Pricing Authority (NPPA) to regulate the prices of essential drugs

Pharmacy Act, 1948 Regulates the profession and practice of pharmacy within the country. Provides provisions to constitute a Central Pharmacy Council of India and State Pharmacy Councils

1970 `445 CRORES

1947 `10 CRORES

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cover )

EVOLUTION OF INDIAN PHARMA REGULATORY FRAMEWORK Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, gives insights on the transformational journey of India’s pharma industry coming to par with the global standards, since independence

T

ill independence in 1947, India has been following or rather copy-pasting the British regulations, whether in the Drugs Act, 1940, the (Indian) Patents and Designs Act, 1911 or the Medicinal and Toilet Preparations Act, 1955 (which emerged from Prohibition Act and Narcotic Act). Even though the Drugs Act was passed by the Indian Parliament in 1940 and the Drug Rules became official in 1945, the effective implementation commenced only many years later, after independence in 1947. Most Indian companies were manufacturing extracts, tinctures and medicines which were ‘compounded’ in the Medical Practitioner’s clinic. The Drugs Act, 1940 was later amended to include cosmetics in late 60s and further amended to include Ayurvedic preparations in the 80s. The Indian drug laws and its administration is in the Concurrent List (There are three lists, Union list, State list and Concurrent List), this made the uniform implementation of the Drugs & Cosmetics Act, a big challenge in India. Even though,

26 EXPRESS PHARMA August 1-15, 2017

the Act and Rules for drug formulations were already in place during independence, the enforcement was extremely weak and slow in implementation. Drugs Control Administrations were set-up in or around 1955 to 1957 in Bombay State (Maharashtra and Gujarat), Mysore State (Karnataka) and Madras Presidency/State etc.

Pharmacy Act, 1948 was the most important legislation post-independence. BV Patel, Drugs Controller of the Bombay province, ML Khorana, UDCT and KG Ananthanarayan, Haffkine Institute constituted the first pharmacy tribunal to formulate the pharmacy regulations. After Pharmacy Council of India and various State Pharmacy Councils were formed in the 1950s and 1960s, consequent to the linguistic division, the states of Maharashtra and Gujarat were born in 1960. Patel was transferred as the Director of Drugs Control in Gujarat and Dr MK Rangnekar became the Director of Maharashtra Drugs Administration. The states of Karnataka and Madras were born too. It is around this time that the implementation or

( enforcement of Drugs and Cosmetics Act, commenced in India. While the pharmaceutical industry in India was 'formally' born in West Bengal (during the days of Acharya PC Ray), with pharma companies such as Dr Paul Lohmann, Bengal Chemical, Bengal Immunity, Smith Stanistreet, Dey’s Medical and others.

Bombay (Maharashtra) and Gujarat emerged as pharma pioneers during 1960 to 1970 period. While Haffkine Institute (vaccines) and Cipla were industry leaders in Bombay, Alembic, Sarabhai and Gujarat Pharmaceuticals took lead in pharma industry growth in the western region.

It is noteworthy that the handholding, industry-friendly, problem solution approach of industries in Maharashtra and

The entrepreneurdriven Indian pharma Industry is bound to emerge as a global pharma superpower in next 10 years Gujarat helped the growth of pharma industry in western India. The role of Central Drugs Standard Control Organization (CDSCO) or the office of the Drugs Controller (India) in Delhi remained restricted to law making till the 1990s.

Central Drugs Controller’s approaches being friendly to industry and State Drugs Control [later named as FDAs (Food and Drugs Administration], there were harmonious growth of the pharma industry in India, in spite of the 'Concurrent Status.'

Amendments Major amendments to the

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Drugs and Cosmetics Act, 1940 were incorporated over the years including Schedule M, Schedule Y etc. In early years, it was the regulators who used to take a lead in resolving quality related prob-

lems of the industry. For example, the 'particulate matter' in injections was a perennial problem which needed technical and technological solutions. The Drugs Administration under Dr Rangnekar, took

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the lead jointly with industry and professional associations like Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Association (IPA) to conduct extensive workshops and lec-

tures by experts (including overseas speakers) to resolve the problem, which was eventually eliminated completely.

Regulatory agencies working closely in tandem with the industry, catalytically promotes

cover ) the healthy quality growth of the industry. While we have come a long way as regards to the quality of the regulators at CDSCO/DCG(I) office, the non-uniformity at the state level of FDAs in the country is alarming. While the state level drugs control officers have formed an association, 'The All India Drugs Control Officers’ Confederation (AIDCOC) and have opened www.drugscontrol.org, it is hoped that this initiative will help boost the standards of quality of medicines as well as the GMP in manufacturing industry and related supply/distribution chain thereof.

While the Central Drug Administration has made steady progress from the times of Borkar to current team of Dr GN Singh, DCG(I) and the two Joint DCGIs, Dr VG Somani and Dr Eswara Reddy, more needs to be done to bring Indian regulatory set up to global standards. Dr Bangarurajan, Dy DCG(I) is contributing by working with industry on quality data integrity and other issues in the West Zone.

Under the aegis of the CDSCO/DCG(I), separate divisions must be set up for (ex:) NCE/NME approvals, biosimilars, herbal and natural products, combinations (FDCs), NDDS, medical devices and of course clinical trials. Team of experts must be appointed in each divisions to interact with industry and provide guidance and assistance for them to contribute to the National

Healthcare needs and global leadership of India in respective fields.

Patents Coming back to patents, need for amending the Patents and Designs Act of 1911 was felt, post-independence. There was no modern medicines or packaged foods or basic fertilizers available in India, because everything was under patents and only available through imports. Various committees, including Parliamentary Committees were appointed, culminating in the Ayyangar Committee (1959 Report of Justice Rajagopala Ayyangar) Report which based itself on an earlier Swan Committee Report of 1948. The much

lauded Ayyangar Committee’s 53 amendments proposed to the 1911 Act, was languishing for nearly 10 years.

The Bill for Patents Act amendment lapsed in Parliament more than once. All was quiet on the patent front for nearly 10 years. All was not well on the mortality/morbidity rates as well in the Indian population post-independence.

It is then, that the famous landmark judgement by Justice Vimadalal was delivered in the Bombay High Court on July 11, 1968. While Hoechst had an Indian Patent No.58716 on Sulphonylureas (Tolbutamide), Unichem had launched Tolbutamide tablets (antidiabetic) in the otherwise starved Indian market.

Unichem was injuncted and found to infringe the product patent of Hoechst. The large diabetic patient pool of India was once again denied access to affordable treatment as the 'Hoechst’s Rastinon' was beyond the reach of Indian public. Once the 'hue and cry' alerted the government of Indira Gandhi, she quickly formed a Parliamentary Select Committee (Atal Bihari Vajpayee was also a member) among other luminaries headed by Dr Susheela Nayyar, following which the Patent Amendment Bill was passed in the Parliament in 1970, followed by the Rules amendment in 1972. As per the amendments to Patent Act 1970, only process patents on

Drugs, Foods and Chemicals were allowable. Product patents on these fields were not eligible to be granted. The rest was history. Indian Pharma Industry grew by leaps and bounds thereafter, by reverse-engineering, supported by IDPL (Indian Drugs & Pharmaceuticals Limited).

There were full supportive initiatives from the government, through Hathi Committee report implementation, ratio parameters (Bulk drugs to formulation ratios were fixed company-wise), import substitution incentives etc.

The Patents Act, 1970, which catalysed the growth of the Indian pharma during the 1970 to 1990 period, threatened the developed countries so much that they came up with the Dunkel Draft Treaty (post Uruguay Round) which led to the TRIPs Agreement (Trade-Related aspects of Intellectual Property Rights) and the transition from GATT to WTO, post globalisation and harmonisation. India had to consequently amend the Patents Act, 1970, first in 1995 (1999) to provide for transition provisions (mailbox for Product Patent Applications) followed the 2nd and 3rd Amendments in 2002/2003 and 2005 respectively. Patent term got enhanced uniformly to all fields of technology to 20 years on May 2003 (with retrospective effect for valid patents).

Full-fledged product patent regime returned to India in 2005 leading to opening of

India is substantially on track to meet global standards on pharma regulatory framework. Major restructuring and revamping are in progress in areas such as biosimilars, FDCs, GMP and related areas including ICH, PICs, clinical trials, Schedule Y, Medical Devices and pharmacovigilance which could strengthen the regulatory systems in India

28 EXPRESS PHARMA August 1-15, 2017

( flood gates to product patents and infringement litigations.

The 10-year period of 2007 and 2017 has seen a large number of patent infringement suits, most of them in Delhi High Court. A large number of ex parte ad-interim injunctions were granted in pharma patent litigations between 2010 and 2016. The now famous 'Gleevec' case started in 2005 and was finally decided

by Supreme Court in April 2013. The one and only compulsory licence grant on ‘Sorafenib’ to NATCO (against Bayer Nexavar) created severe backlash from developed Nations and Bigpharma (US in particular). The Patent Rules 2016 provides for 'expedited examination' facility, subject to conditions. Indian Intellectual Property offices have now become fully 'online' and have become substantially transparent. Other Acts and Rules relating to Biodiversity, Plant Varieties Protection Act, Trade Marks, Designs have all been promptly enacted and enforced by India. Major reforms in Narcotic Control provisions have also been enacted.

leaders due to the sandwiching effect from stringent squeeze of DPCO. MSME pharma manufacturers are bound to feel the pressures for compliance to higher level, matching International Stan-

dards of GMP (beyond WHOGMP) and other regulations.

The environment related pollution control issues under the aegis of the NGT (National Green Tribunal) is adversely impacting the growth of the

Pharma API industry in India.

The silver lining among these clouds is that the entrepreneur-driven Indian pharma Industry is bound to ride on these challenges and emerge as a global pharma

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superpower in next 10 years, if not through 'Make in India' by 'Make overseas' route, since Indian pharma is now mastering the International regulatory compliance standards.

Innovative solutions for pharmaceutical applications /// Research & development made easy LIFETIME WARRANTY!

SMART AND INTELLIGENT SOLUTIONS › timer function › hardened glass surface › optional* control via PC (*labworldsoft) › torque trend measurement

Meeting global standards India is substantially on track to meet global standards on pharma regulatory framework. Major restructuring and revamping are in progress in areas such as biosimilars, FDCs, GMP and related areas including ICH, PICs, clinical trials, Schedule Y, Medical Devices and pharmacovigilance which could strengthen the regulatory systems in India.

At a time when the industry leaders are being adversely impacted by the negative attitude of US FDA inspection audits, the industry need to take these challenges as opportunities for further upgradation and compliance. Close cooperation of Indian CDSCO/Office of DCG(I) with overseas regulators are helping to upgrade Indian quality and regulatory standards. However, these positive measures are bound to impact profits of market

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cover )

Upgradation of GMP since independence Kapil Bhargava, Former, Dy Drugs Controller (I) CDSCO, elaborates on India's journey in pharma sector post independence till today

I

n earlier years (1940s and 1950s) manufactured formulations were tincture spirits, pills and ointments. The pharmacy practice was centred to compounding the powders (prepared either from medicinal powders or by pulverising the pills) and dispensed in folds of butter paper. Students were even taught in pharmacy classes as to how to make a ‘neat paper packet’ for patients.

Manufacturing was centred in the eastern part of India, mainly Kolkata and few other towns of Uttar Pradesh (both having a strong presence of industry climate). This was probably because pharmacy education started in Banaras Hindu University (1950s). In Kolkata, Dey’s Medical Store used to be main retail pharmacy along with a few smaller ones. After retail dispensing and practising pharmacy, companies thought of manufacturing and producing some liquid oral preparations.

Around the same time, few of the companies from western world (mostly the UK and the US) got attracted to India and set up their plants in India.

Squibb chose western part (Baroda) while others like Martin & Harris and Organon set up plants in Kolkata and number of others were concentrated in Mumbai. This was in early to late 50s in the 19th century. Manufacturing in other cities also sprang up and a number of tiny manufacturing sites (again promoted by retailers and whole-

30 EXPRESS PHARMA August 1-15, 2017

sellers) produced mostly liquids and syrups to sell in the local markets and manufacturing license were also granted to these units.

The regulations Conditions for granting license were mentioned in Drug Rules and were also mentioned in a separate schedule of the rules. A few details were mentioned in a separate schedule, a Schedule M of Drugs & Cosmetics Rules, which was then sub-titled as 'requirements for manufacturing premises.' Except few conditions such as minimum area needed and list of some machinery, it did mention about other details of pharma manufacturing.

Smaller factories manufacturing formulations were mostly located in residential areas . In SSI, the procedures were mostly manual or partly mechanical and a general cleanliness and hygiene was expected to be maintained.

Gradually few international medicinal products were manufactured here. Tablets and other formulations were manufactured mainly in western part of India. Penicillin was then a recent antibiotic and sulphonamides were anti-bacterial. Though penicillin was considered a sensitive medicinal product, the words 'contamination' and 'cross-contamination' were not common. Schedule M then, did not mention any of these conditions which need to be adopted by manufacturing sites. Multi-national companies

operating in India followed their principle's manufacturing document for safer products which mainly were manufacturing procedures (Manufacturing practices and operating procedures were not popular terms).

The progression As years passed, product range also expanded. Antibiotics, hormones, anti-cancer and other very sensitive category products viz. corticosteroids, were being manufactured in form of oral preparation (tablets capsules and liquids) and parenteral preparations both. Bigger companies introduced manufacturing practices and operating procedures which later were called as good manufacturing practice(GMP) and standard operating procedures (US FDA further added the word ‘current’ as for them good was not enough).

GMP regulations thus have come a long way since its introduction in 1960 by Canadian Authorities which started as QUAD programme. In India, GMP acceptance spurred by serious events of contaminated IV Fluid

in UP (BJ Pharma Kanpur) and Gujarat (Sanitex Baroda) in early 70s (1971 – 1975) resulting into deaths of a number of patients. Regulators here realised the dangers to patient community due to quality failures in manufacturing. They realised that poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. A poor-quality medicine may contain toxic substances that have been unintentionally added. A medicine that contained little or none of the claimed ingredient will not have the intended therapeutic effect.

They realised GMPs as regulatory codification of generally known quality principles.

Since mid-70s, WHO has been supporting medicines supply to various countries (mainly prophylactic vaccines and other diseases like malaria and tuberculosis) and was procuring medicines from manufacturing locations spread over several countries. It introduced scheme of certification of pharmaceutical product (COPP) moving in international commerce. For this scheme, ensuring GMPs was essential.

World Health Assembly in 1975 (WHA 28.65) published GMP text that was titled “good manufacturing practice and quality of drugs.” This text was implemented for ensuring GMPs for purpose of grant of COPP. Since India did not have a GMP text of its own, the Indian companies participating in

COPP scheme and the regulators, followed 'good manufacturing practice and quality of drugs' document for ensuring GMPs.

The GMP regulation In mid 80s, work began to draft GMPs for India and revise the then Schedule M. The initiative taken and guidance provided by the then Drugs Controller India, Dr PK Gupta. Schedule M was revised in 1988 and was sub-titled as Good Manufacturing Practice instead of 'requirements for manufacturing.' It addressed a number of vital quality issues which were earlier taken for granted. These, besides other factory act requirement, were manufacturing operations and controls precaution against contamination, mix-up and quality control system.

Cross contamination issue was addressed emphatically and adequate segregation of contamination causing ingredients appeared for the first time as a part of GMP. Since early 90s, Indian companies were exporting their products to 100 plus countries.

New manufacturing locations emerged and companies were constructing bigger and better factories, providing better manufacturing environment. Indian companies were also venturing into API manufacturing to reduce their import dependency.

There was an improvement in manufacturing equipment quality. With the advancement of NCEs, newer and potent molecules were being formulated for

( patients and GMPs were being enhanced by the manufacturers.

Quality concept graduated from 'quality control' to 'quality assurance.' GMP text was under revision once again for ensuring more rigorous controls. For other regions of SouthEast Asia, WHO took initiative and published 'Specifications for Pharmaceutical Preparations' in 1992. It addressed vital activities such as quality assurance, validation, water systems, air-systems, self-inspection and many others. It also spelt out GMPs for APIs. Once again Dr PK Gupta was mainstay for compiling this on behalf of WHO. Since India’s drug control administration and government machinery supported GMP implementation and was bringing this to forefront of regulatory supervision, it started revising Schedule M. In doing this, stakeholders including manufacturers form SME were invited to participate in drafting Schedule M. The final version was published in December 2001. Since changes were quite a few, good briefing through workshops and seminars was given to manufacturers and regulators by CDSCO. The revised Schedule M was made applicable since January 2004 and is under implementation today.

Current scenario India’s capacity to supply generic medicines to even advanced countries during the past ten years or so have increased manifolds. Newer quality concepts emerged and Indian manufacturers have positioned themselves in advance science-based products adopting recent technologies. Quality concepts have improved and there is an effort to further revise Schedule M. The first draft has been published for public comments.

Though patchy in contents at places, it is appearing to be graduating from 'quality assurance' to 'quality management system' incorporating the designed to minimise the risks involved in any pharma production that cannot be eliminated through testing the final product. It has emphasised that good quality

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must be built in during the manufacturing process and cannot be tested into the product afterwards.

In the past 70 years, since independence pharma manufacturing has seen huge changes

and have given good products to ailing community. Manufactures and entrepreneurs today have understood that GMPs prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it

THE MAIN FOCUS

is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.

Quality management is not merely quality control, it mostly concerns quality assurance and

QA gives confidence for GMPs. All concerned have realised that making and distributing poor quality medicines leads to loss of credibility for everyone, both public and private health care and the manufacturer.

cover

)

DOWN MEMORYLANE

Gandhi's visit to Cipla in 1939

Image courtesy: Cipla archives

Independence Day flag hoisting at Cipla 1947

Image courtesy: Cipla archives

Image courtesy: ACG Worldwide

President of India, Neelam Sanjiva Reddy awards ACG for best employer of the physically handicap Image courtesy: ACG Worldwide

The initial ACG Caspules Team

Meeting with KC Pant, Union Minister of State for Finance and Panampally Govind Menon at the Dept of Chemical Technology auditorium in Matunga on October 27, 1964 Image courtesy: IDMA

Meeting with Drug controller PS Ramchandran presenting manufacturers problem. On the right is AV Mody, Chairman, Unichem and GP Nair, Chairman, BDH is on the left Image courtesy: IDMA

32 EXPRESS PHARMA August 1-15, 2017

(

Bio-chemical standardisation laboratory

Image courtesy: Alembic Pharmaceuticals

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THE MAIN FOCUS

Bonded laboratory and warehouse for spirituous preparations Image courtesy: Alembic Pharmaceuticals

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MANAGEMENT REPORT

Pharma,medical and biotech witness 290 deals worth $ 89.9 bn in second quarter: Report Mergermarket's Sector Trend Report on pharma, medical and biotech sectors reveal $166 billion that changed hands across 658 deals during the first half of 2017 accounted for an 11.1 per cent market share of global M&A. Excerpts

P

harma, Medical & Biotech (PMB) in Q2 (290 deals, $ 89.9 billion) saw its strongest quarterly value since Q3 2015 (US$ 101.7 billion), partially as a result of Becton, Dickinson and Company’s $ 23.6 billion deal to buy C.R. Bard in April. The $ 166 billion that changed hands across 658 deals during the first half of 2017 accounted for an 11.1 per cent market share of global M&A. Yet, despite it capturing a significant market share, the sector was still 4 per cent lower in value with 107 fewer deals compared to H1 2016 (765 deals, $ 172.9 billion).

Combined, the Johnson & Johnson and Becton deals accounted for 32.1 per cent of global PMB value and as a consequence the average deal size increased to $ 512 million, the second highest value on Mergermarket record (since 2001).

Despite a slowdown in activity, the US contributed a substantial portion to global PMB dealmaking. The country was responsible for 244 deals worth a total $ 98.8 billion - a 51.5 per cent increase by value compared to H2 2016 (261 deals, $ 65.2 billion), moving back towards the levels seen in the first half of 2016 (296 deals, $116.3 billion). The country attracted four $ 5 billion-plus deals worth a combined $ 47.6 billion, versus five big ticket deals at $ 84.6 billion announced in H1 2016. Uncertainty around US corporate tax reform and President Trump’s pledge to cut high consumer drug prices were instrumental in slowing activity.

Meanwhile, Europe registered 221 deals worth $ 51.6 billion in H1 2017, representing a 40 per cent increase in value with 37 fewer deals compared to H1 2016 (258 deals, $36.8 billion) and recording its highest average deal size on Mergermarket record of $ 622 million. Despite the region’s PMB market share dropping to 7 per cent, Asia-Pacific’s (excl. Japan) deal-

making saw the second highest H1 value and the third highest H1 deal count on record. The region registered 117 deals at $12 billion and 7.8 per cent up by value compared to H1 2016 (129 deals, $ 11.1 billion). PE buyouts in the region achieved a record H1 value with 18 deals announced at $ 3.3 billion. Across the sub-sectors, Medical was most active PMB sub-sector in Asia-Pacific with 65 transactions recorded at $ 5.3 billion and up by 7.2 per cent in value compared to H1 2016 ($ 5 billion, 65 deals). Globally, the Biotechnology sub-sector saw 81 deals registered at $ 52.4 billion, a value increase of more than eight times compared to H1 2016 ($ 6.3 billion, 87 deals) and a record H1 value on Mergermarket. Values for H1 have already exceeded full year totals for each period since 2009 ($ 54.8 billion). However, the most targeted sub-sector by deal count remained Medical with 437 deals announced at $ 76.8 billion and down by 7 per cent in value from H1 2016 (489 deals, $ 82.6 billion).

Private equity firms’ interest in the pharma and medical assets remains strong with buyout activity accounting for 128 deals worth $ 33.6 billion, the second highest H1 both by deal value and count on record. Exits were also high with 111 deals announced at $ 40.2 billion, the third highest H1 both by value and count.

Deal value was mainly spurred by Abu Dhabi Investment Authority and GIC’s $ 9.1 billion takeover of US-based contract research organisation (CRO) Pharmaceutical Product Development (PPD) in a secondary buyout from Carlyle and Hellman and Friedman, and Pamplona’s acquisition of US-based PAREXEL for $ 4.9 billion as a result of consolidation across the healthcare services sector. The future remains positive for PMB due to affordable financing and companies seeking

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MANAGEMENT next-generation technologies and businesses developing health services with stable revenue generation. Dealmaking is expected to increase in the medical services sector due to healthcare systems implementing cost-cutting measures, so that outsourcing becomes a cheaper and more efficient way to assist patients. Private equity firms will also be active in behavioral health transactions due to increasing demand, insurance coverage, good cash flows and legislative reforms.

Drivers Uncertainty regarding changes to the Affordable Care Act Heat chart based on potential companies for sale has been somewhat of a drag on M&A activity, noted Pfrang of Deloitte & Touche. Deals that were not getting done are now more likely to move forward, once new legislation of any kind is approved. It is not that the market thinks the proposed legislation in its exact form will be approved, but it gives the market an idea of the direction that the Trump administration is heading. Dealmaking in 2017 in the US will be strong in alternative sites of care, like home health. Anything with the potential to be relevant in a dif-

36 EXPRESS PHARMA August 1-15, 2017

ferent care delivery model, and to help with lowering costs, will also be attractive, he added.

Healthcare IT and data-driven businesses would fall into this bucket. Pfrang cautioned, however, that healthcare IT is a crowded space. Valuations are high, and not every company is going to survive. “There is a lot of unproven technology,� he

said. European healthcare continues to drive investment and M&A in technologies that increase patient access to healthcare, promote better health outcomes and reduce costs. Seventure Partners for example invested in financing rounds of Machtfit and Push Doctor, both companies specialising in connected health, given

the growth potential in this innovative area. As healthcare systems continue to be squeezed by pricing pressures and local reforms, connected health or mHealth businesses fill the funding gap by enabling remote access to physicians, increase patient compliance, and provide analytics and technologies that promote tailored pa-

tient solutions. While pharma will remain the standard of care, an increase in chronic and rare diseases will call for consolidation among digital health providers and advanced diagnostics. Such companies are able to provide technologies and analytic tools that preempt and manage diseases with better healthcare outcomes.

MANAGEMENT

Global Clostridium difficile infections market to reach $1.7 bn by 2026 Major drivers of the growth include the projected launch of prophylactic options for the prevention of C. difficile, microbiological approaches for the treatment of recurrent CDIs THE CLOSTRIDIUM difficile infections (CDIs) space across the seven major markets of the US, France, Germany, Italy, Spain, the UK and Japan, is set to grow from just under $630 million in 2016 to almost $1.7 billion by 2026, representing a compound annual growth rate of 10.2 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that the major drivers of this growth include the projected launch of prophylactic options for the prevention of C. difficile, microbiological approaches for the treatment of recurrent CDIs (rCDIs), and novel antibiotics positioned to reduce the rate of disease recurrence relative to the standard of care.

Thomas Moore, Healthcare Analyst, GlobalData, explains, “Current treatment options are generally limited to antibiotics, with orally administered van-

comycin considered the standard of care.

Some pharmaceutical companies are developing non-antibiotic alternatives in the hope that they will provide an attractive option for physicians. For example, Merck’s monoclonal antibody, Zinplava (bezlotoxumab), was approved by the FDA in October 2016, and is the first nonantibiotic option indicated to treat CDIs.” Several investigational products aim to leverage the clinical potential of faecal microbiota transplants (FMT) to create a drug that lowers the rate of recurrence for patients recovering from CDIs. Seres Therapeutics’ SER-109 and Rebiotix’s RBX2660 are both FMT-derived therapies that aim to provide an alternative for physicians with strong clinical efficacy and safety data. Both have completed Phase II clinical efficacy trials, and will be positioned to target patients with rCDI. EP News Bureau

APAC colorectal cancer therapeutics market to reach $8 bn by 2023 Growth will be driven by the expected approval of promising therapies THE COLORECTAL cancer market across the Asia-Pacific (APAC) region, which covers China, India, Australia, South Korea and Japan, is set to rise from $4.7 billion in 2016 to almost $8 billion in 2023, representing a compound annual growth rate of 7.9 per cent , according to business intelligence provider GBI Research. The company’s latest report states that this relatively strong growth will be driven by the expected approval of promising therapies within several distinct patient segments, as well as the growing market uptake of therapies already approved in Japan, South Korea and Australia.

Early detection of colorectal cancer is

strongly associated with an increase in survival rates, so the APAC region will see a considerable effort to improve the diagnostic techniques for patients in stages I-III of the disease.

As transforming biomarker discoveries into useful diagnostics is a slow and gradual process, however, the number of patients diagnosed in early-stage colorectal cancer will not drastically increase over the forecast period, except in India and China, where early diagnosis is very low due to a lack of awareness and healthcare resources. In this way, new drugs will play a more pivotal role in driving market growth.

EP News Bureau

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EXPRESS PHARMA

37

August 1-15, 2017

RESEARCH UPDATES

HIVdrug resistance could undermine progress in AIDS battle: WHO Over 10 per cent of HIV patients starting antiretroviral drugs were resistant to widely-used medicines

R

ising levels of resistance to HIV drugs could undermine promising progress against the global AIDS epidemic if effective action is not taken early, the World Health Organization (WHO) said on Thursday.

Already in six out of 11 countries surveyed in Africa, Asia and Latin America for a WHOled report, researchers found that more than 10 per cent of HIV patients starting antiretroviral drugs had a strain resistant to the most widely-used medicines. Once a threshold of 10 percent is reached, the WHO recommends countries urgently

review their HIV treatment programmes and switch to different drug regimens to limit the spread of resistance.

HIV drug resistance develops when patients do not stick to a prescribed treatment plan - often because they do not have consistent access to proper HIV treatment and care.

Patients with HIV drug resistance start to see their treatment failing, with levels of HIV in their blood rising, and they risk passing on drug-resistant strains to others. The WHO’s warning comes as the latest data from UNAIDS showed encouraging progress against the

worldwide HIV/AIDS epidemic, with deaths rates falling and treatment rates rising. Some 36.7 million people around the world are infected with HIV, but more than half of them - 19.5 mil-

FDA approves Gilead’s drug for chronic hepatitis C patients Vosevi is the first drug hep C which inhibit NS5A protein GILEAD SCIENCES said on Tuesday that the US Food and Drug Administration approved its hepatitis C drug for patients who had failed to respond to prior treatments.

Vosevi is the first drug to be approved for hepatitis C patients already treated with Sovaldi or other drugs, which inhibit a protein called NS5A, the FDA said in a separate release.

The approval is based on data from two late-stage studies, which evaluated 12 weeks of the drug in previously treated patients, the company said.

However, the approval comes with a boxed warning about the risk of hepatitis B virus being reactivated in pa-

38 EXPRESS PHARMA August 1-15, 2017

tients infected with both hepatitis C and hepatitis B. Gilead, whose growth has been fueled by its arsenal of

hepatitis C drugs, had warned earlier this year that sales of its high-priced drugs were declining due to fewer patients being deemed eligible for treatment and rising competition.

First-quarter sales of the company's hepatitis C drugs, Sovaldi, Harvoni and Epclusa, slumped to $2.6 billion from $4.3 billion a year earlier.

Hepatitis C causes inflammation of the liver that can lead to diminished organ function or its failure. An estimated 2.7 million to 3.9 million people in the US have chronic hepatitis C infection, according to the Centers for Disease Control and Prevention.

Reuters

lion - are getting the antiretroviral therapy medicines they need to suppress the HIV virus and keep their disease in check. The WHO said, however, that rising HIV drug resistance trends could lead to more infections and deaths. Mathematical modelling shows an additional 135,000 deaths and 105,000 new infections could follow in the next five years if no action is taken, and HIV treatment costs could increase by an extra $650 million during this time.

"We need to ensure that people who start treatment can stay on effective treatment, to prevent the emergence of HIV drug

resistance," said Gottfried Hirnschall, director of the WHO's HIV and hepatitis programme.

"When levels of HIV drug resistance become high we recommend that countries shift to an alternative first-line therapy for those... starting treatment."

The WHO said it was issuing new guidance for countries on HIV drug resistance to help them act early against it. These included guidelines on how to improve the quality and consistency of treatment programmes and how to transition to new HIV treatments, if and when they are needed.

Reuters

Ablynx signs deal with Sanofi worth $2.8 billion The deal expands the Sanofi's drug discovery efforts in immunology FRENCH DRUGMAKER Sanofi boosted its early-stage pipeline in immunology on Thursday by signing a deal with Ablynx that could earn the Belgian biotech firm as much as 2.4 billion euros ($2.8 billion).

Initial payments are a lot less, with Ablynx receiving an upfront payment of 23 million euros and 8 million in research funding, but big milestones will kick in if any of the experimental projects achieve commercial success.

The deal gives Sanofi access to a total of eight of Ablynx's so-called nanobody medicines, which are derived from camel and llama antibodies. The focus is on developing products to treat immune-mediated inflammatory diseases, the companies said.

For Sanofi, the deal expands the company's drug discovery efforts in immunology at a time when it is launching a promising new treatment for severe eczema.

Reuters

US FDAapproves Puma Biotech’s breast cancer treatment Neratinib lowers the risk of the disease returning after initial treatment

THE U.S. Food and Drug Administration (FDA) approved Puma Biotechnology's experimental breast cancer drug that lowers the risk of the disease returning after initial treatment.

The FDA said in a preliminary review that Puma Biotech's drug, neratinib, appeared to be effective.

Neratinib — the first treatment of its kind — is designed to treat earlystage breast cancer in patients with the HER2 genetic mutation whose tumor has been surgically removed and who have been treated with Roche's Herceptin.

After two years, 94.2 per cent of patients treated with neratinib had not experienced cancer recurrence or death, compared with 91.9 per cent of patients receiving a placebo, the FDA said in a statement.

Breast cancer is the most fre-

Puma Biotech’s drug, neratinib, appeared to be effective, said FDA quently diagnosed cancer in women.

HER2-positive breast cancer accounts for 20 to 25 percent of all cases.

The current standard of care in patients with early-stage breast cancer is chemotherapy and one year of Herceptin treatment following surgery.

About 20 percent of patients with HER2-positive early breast cancer see their cancer recur within five years following standard treatment.

Reuters

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EXPRESS PHARMA

39

August 1-15, 2017

RESEARCH

Study finds slight autism risk link to antidepressants in pregnancy University of Bristol, analysed data from more than 254,000 children living in Stockholm, Sweden

Children exposed to antidepressants during their mothers' pregnancies seem to have a slightly higher risk of autism than children whose mothers had psychiatric disorders but did not take antidepressants while pregnant, a study has found.

But publishing their finding, researchers said the results should not cause alarm, since the absolute risk of a child developing autism remains very small.

Depression is common in women of childbearing age. In Europe, experts say that between 3 and 8 per cent of pregnant women are prescribed antidepressants.

Several previous studies have suggested associations between antidepressant use dur-

40 EXPRESS PHARMA August 1-15, 2017

In Europe, between 3 and 8 per cent of pregnant women are prescribed antidepressants ing pregnancy and autism in offspring, but researchers say it is not clear whether this is due to the illness itself, the antidepressants, or other unknown factors.

A Canadian study published late in 2015 found that women who take antidepressants while

pregnant may be more likely to have children with autism - but it also noted that the overall risk is very low.

For this research, a team led

by Dheeraj Rai at Britain's University of Bristol, analysed data from more than 254,000 children living in Stockholm, Sweden, aged between 4 and 17.

Their mothers were either women with no mental illness who had not taken antidepressants, women who'd had a disorder and taken antidepressants while pregnant, or women with psychiatric disorders who had not taken antidepressants during pregnancy.

Of the 3,342 children exposed to antidepressants during pregnancy, the study found that 4.1 percent were diagnosed with autism, compared with 2.9 percent of the 12,325 children not exposed to antidepressants whose mothers had a history of a mental illness.

The researchers stressed, however, that the absolute risk was small: More than 95 percent of women in the study who took antidepressants during pregnancy did not have an autistic child.

They estimated that, even if the association between antidepressant use and autism is causal, only 2 percent of cases would be prevented if in future no women with psychiatric disorders took antidepressants when pregnant.

In a commentary on the findings, published in the BMJ British Medical Journal, Diana Schendel at Denmark's Aarhus University said the findings "should be viewed through the kaleidoscope of possible causes of autism".

Reuters

Blood sugar swings tied to depression in elderly with type II diabetes Blood sugar control - might help to prevent depression in elderly people GREATER UPS and downs of hemoglobin A1c (HbA1c), a marker of long-term blood sugar levels, are associated with a higher number of symptoms of depression in elderly individuals with type II diabetes, a recent Israeli study finds.

“The results suggest that maintaining stability in glycemic (‘blood sugar’) control may be important for prevention of depressive symptoms in elderly diabetic patients,” Dr Ramit Ravona-Springer from Sheba Medical Center, Ramat Gan, and Tel-Aviv University told Reuters Health.

People with type II diabetes are twice as likely as people without diabetes to develop depression, which affects as many as a third of individuals 65 years and older. Variability in HbA1c has been associated with complications of diabetes, but there is little information about its relationship with depression, the study team writes in Diabetes Care.

Ravona-Springer’s team analyzed about nine years’ worth of data on 837 people with type II diabetes whose average age was nearly 73 years. The information included around 18 HbA1c measurements over the years for each participant, and results from a depression assessment at the start of the study period.

Average HbA1c was not associated with depressive symptoms, but the variability of HbA1c measurements was, such that each 1 percent increase in variability was associated with a 29 percent increase in the number of depressive symptoms, researchers found.

The relationship between HbA1c variability was true regardless of HbA1c level, but it was strongest among people whose HbA1c was above 7 percent, a common target for blood sugar control.

The researchers admit that the results just show an association and don't necessarily mean that blood sugar variability causes symptoms of depression.

Nevertheless, they conclude that better long-term stability of HbA1c - in other words, more consistent blood sugar control might help to prevent depression in elderly people with type II diabetes.

“This study is ongoing,” Ravona-Springer said. “We thus expect to have even better understanding of the directional relationships of glycemic control and other diabetes-related characteristics with depression as we start analyzing longitudinal data,” she said.

"The study hints at the importance of achieving stable A1c values at a certain age/point in a patient‘s diabetes history in contrast to trying to reduce A1c,” said Dr. Dominic Ehrmann from the Research Institute of the Diabetes Academy Mergentheim (FIDAM) in Bad Mergentheim, Germany, who has also studied the link between depression and diabetes. “Depression symptoms should be an important factor in clinical decision making in elderly patients,” concluded Ehrmann, who wasn’t involved in the current study.

Reuters

PHARMA ALLY I N T E R V I E W

We always drive for enhancements and improvements in the way we interact and serve our customers Dr Susanna Baque, Global Senior Director of Customer Experience, SCIEX elucidates about how SCIEXNow Customer Experience Centers and online portal are providing a single platform for customers to get the support they need globally Tell us more about SCIEXNow Customer Experience Centers (CXC) and SCIEXNow Online?

Which services are included?

Customers need information at their fingertips and rapid access to support whenever necessary, whether by phone or online. The SCIEXNow Customer Experience Centers – a network of dedicated experts offering telephone and remote support – and SCIEXNow online portal have been designed with customers in mind, ensuring that support is readily and conveniently available.

Previously, customers had multiple contact numbers for SCIEX – i.e. the service engineers direct numbers, the sales representatives– and there was no tracking system, making it difficult to monitor the status of a call. Of course our engineers provide best in-class service to customers, but they needed to be on the field and at the same time handle other customer’s calls, what was not always convenient. Customers also told us that they want to talk to the right person the first time they call, and not have to keep repeating the same information again and again to different people. This is why we established the SCIEXNow Customer Experience Center offering technical support in local language, providing a single point of entry for any enquiry. One call is all it takes to log an enquiry, which is then tracked until completion.

What’s the difference between SCIEXNow online and earlier

42 EXPRESS PHARMA August 1-15, 2017

customer support? How can customers access SCIEXNow services?

The main difference is that we can provide a single platform for customers to get the support they need, either by calling the SCIEXNow phone number (000-800-919-0274), or submitting a case via our customer portal, SCIEXNow Online, and they can be assured that the request is tracked and they can more easily follow up progress of it.

We have our frontline team using their expert knowledge to triage each enquiry and pass it directly to either the Technical Assistance Center (TAC) group or the Software and Application Support (SAS) team, dedicated experts working to support our customers remotely. TAC and SAS have technical specialists located across the region that, can access customers’ systems remotely for troubleshooting and in many occasions solving the issues. These technical experts will support the customers remotely first, and if needed will dispatch an expert on site.

Why has SCIEX decided to launch SCIEXNow CXC and SCIEXNow online? Which techniques are used in it?

We launched the first SCIEXNow Customer Experience Center three years ago in Europe, with the aim to provide a single entry point for customers to get answers from SCIEX in an efficient way. We expanded later to North America,

Japan, China and rest of Asia; and now in India. We have the latest infrastructures in call centre systems and CRM (Customer Relation Management) systems to be able to provide the best support and track all inquiries.

SCIEXNow Online was launched once the infrastructure and people (Customer Experience Centers) were in place, and has been developed to ensure uptime is addressed in a critical manner. SCIEXNow Online complements the Customer Experience Centers, providing personalised support throughout the instrument’s life cycle, including system and service call management.

Users can also access articles offering straightforward self-help, the SCIEXUniversity and training catalog, and the Technical Live Chat service.

Customers can easily track support calls, monitor an instrument’s real-time status, take part in discussions with the online community, or follow their education through the SCIEXUniversity’s range of eLearning courses, which include interactive videos.

What are the characteristics of SCIEXNow Customer Experience Center and SCIEXNow online? What makes the product different from your competitors?

What are the advantages of SCIEXNow online?

Whether a customer has a simple information request, needs help to develop a new workflow or optimising an existing one, or is facing technical issues, we know how important fast resolutions are to a lab’s results. SCIEXNow Customer Experience Centers provide the phone single entry for all customers’ enquiries. And integrated to that, SCIEXNow Online is the latest innovation to optimise our customers’ experience with SCIEX, allowing researchers to check and manage everything online.

Integrated tools like a Knowledge Base search and multiple ways to contact us enable customers to find the answers they need for themselves, or with one click, a SCIEX expert is ready to assist them. And all interactions are tracked and visible for customers online.

No competitor has the integrated systems,

processes, experts and online tools to serve customers and provide the answers they need, when they need them, and in an omnichannel approach. The key thing for our customers is ready access to high level of service. With SCIEXNow, customers have a choice of contact options.

While the Customer Experience Center makes phone contact simple, many people prefer to contact online. The focus is on giving customers the support they need in a way that works for them.

SCIEXNow CXC was first launched in Europe in 2014, then in phases to rest of the world. It has been launched in India now. Please share some successful cases studies as to how customer experience changed within this time frame.

The SCIEXNow Customer Experience Centers and SCIEXNow Online portal are growing in popularity as customers increasingly realise the benefits they offer.

Customers no longer have to spend time searching for the right number to call, their service and support calls are fully traceable, and training needs can be addressed via a

choice of online courses. No matter what type of support customers require, it can be rapidly and easily obtained.

SCIEXNow CXC has been launched in India. What similarities and differences do you witness among customers in India and other countries?

We launched SCIEXNow Customer Experience Center on July 10. At the same time, we started promoting the online version, which has been already live since October 2015, but not extensively used by India customers. Customer needs are in general the same in all regions, they want uptime, fast answers, and talk to the right expert to get first contact resolution. We always have regional/countryspecific needs, that we address based on following a standard and global process, with local deployment.

What is the overall customer experience of SCIEX? What steps will SCIEX undertake to improve customer experience?

We ask our customers about the experience with SCIEX in many touchpoints during

their journey, and we gather feedback to continuously improve. The customer experience is positive based on their feedback, but with our SCIEX and Danaher culture of continuous improvement, we always drive for enhancements and improvements in the way we interact and serve our customers.

We have a dedicated global team that I’m leading, with a clear strategy and priority to continuously improve our customer experience. We’re driving different initiatives that are encompassed under what we call the SCIEX 'Customer Success Network': people, processes and tools to make sure we make it easy for customers to do business with us, to get the answers they need, when they need them. SCIEXNow CXC and SCIEXNow Online are part of this success network, and we’re expanding it not only regionally, but also in additional reach for our customers. Innovation is the key, to overachieve customer’s expectations, and most importantly to make it easy for them to be successful. prathiba.raju@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

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Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

EXPRESS PHARMA

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August 1-15, 2017

PHARMA ALLY PRODUCTS

Newtronics launches incubators passive cooling box with temperature indication The Newtronic protable smart incubator is a simple

NEWTRONIC'S PASSIVE boxes for cold chain management are used for transportation and logistics of any temperature sensitive products such as medicine, vaccines, blood, tissues, samples, passive-qualified cooling-ice-box biotech payload etc.

and versatile the digital portable laboratory and medical transporter can both cool or heat and is designed for the transporting of samples, vaccines, pharmaceuticals or indeed anything that needs to be moved under temperature controlled conditions.

Complete with an easy to read digital controller, this carrier uses mains or vehicle power via a 12v socket to cool or heat by way of an environmentally

Features and functions: ◗ Cool boxes with temperature indicator carriers require conditioned icepacks to keep samples cool. ◗ Ice packs contain a PCM liquid prior to being loaded, they to be freeze indeep freezer or freezer of refrigerator. ◗ Different ice packs to be used for different temperatures ◗ Maintain the temperature 2oC to 8oC for 24 hours with the frozen ice packs ◗ Cool boxes are with LCD display temperature indicator in degreeoC ◗ Ice packs to be replaced in case temp beyond desired level. ◗ Continuously monitors sam-

ple by optional data logger. ◗ Lightweight, Convenient: carrier can pick up and deliver ◗ Tough plastic exterior Optional 50 litres deep freezers -20°C can be supplied for freezing ice packs

Specications Model

NLMC-44

NLMC-46

Storage Capacity

1.35 Liters

2.46 Liters

Weight Fully Loaded

4.36 Kgs.

6.36 Kgs.

Weight Empty

2.22 Kgs.

2.98 Kgs.

friendly peltier system. This makes it ideal for transporting

vaccines by road and collecting samples in the field.

Features ◗ Temp range: 0ºC to +50ºC ◗ Supplied with mains and in car power cables ◗ Safe gas free peltier refrigeration ◗ Lightweight and easily transportable ◗ Digital set point display ◗ Easy digital temperature adjustment ◗ Tough plastic exterior Benefits ◗ Active precision heating and cooling ◗ Temperature LCD display. ◗ Temperature control range 0° C to 50° C ◗ Ambient Temperature range 30° C T0 35° C ◗ Precise temperature control keeps samples in near-perfect conditions ◗ Continuously monitors sample by optional data logger. ◗ Lightweight, convenient: carrier can pick up and deliver ◗ 12V DC power of a vehicle or on AC mains when power is available. In addition, if there is no access to power, a portable battery back-up can also be attached to keep the unit running max for three hours.

Specications

(With Empty Ice Packs) External Surface Material

HDPE

HDPE

Model

NLPSI12

NLPSI18

Internal Lining Materrial

HIPS

HIPS

Insulation Material

CFC Free Polyurethane

CFC Free Polyurethane

Storage Capacity

12 Liters

18 Liters 65-80 W 12/24 Volts DC / 110-240 volt AC

Insulation Thickness

32/40 mm

32/35 mm

Voltage

External Dimensions (L x W x H)

24.00 x 24.00 x 30.00 cms

24.00 x 24.00 x 30.00 cms

Internal Dimensions (L x W x H)

09.90 x 09.90 x 16.50 cms

12.20 x 12.20 x 19.00 cms

Temperature Range

65-80 W 12/24 Volts DC / 110-240 volt AC 0C - 50C ( Ambient Temperature)

Storage Dimensions

09.90 x 09.90 x 16.50 cms

12.20 x 12.20 x 19.00 cms

Insulation

CFC free full PU foam core

CFC free full PU foam core

Lid Type Fixing

Removable

Removable

Dimention

290 x 290 x 415

251 x 203 x 508

Number of Ice Packs Require

4

4 Weight

7 kgs.

8 kgs.

Volume of Ice Pack

44 EXPRESS PHARMA August 1-15, 2017

0.6 Liter

0C C Ambient Temperture

PHARMA ALLY

MarkVi Systems launches MARKIPRINTX1JETHP MARKIPRINT X1JET HP is based on reliable MARKIPRINT X4JET technology. This compact and powerful system is available in different, upgradable system versions.

MARKIPRINT X1JET HP is designed for different range of applications i.e. food and beverage, chemical, coated/uncoated materials, timber and the pharmaceuticals industry.

The small and compact integrated controller/printer comes in a single unit. The innovation system codes smooth absorbent and semi-absorbent surfaces – quickly, accurately and reliable. ◗ Innovation technology for printing information directly onto cartons ◗ High availability through car-

terface. ◗ User-friendly due to 3-logic ◗ Select and printing directly upto nine layouts/labels

Universal and flexible use

tridge technology, tested and proven a million of times ◗ High quality, high resolution printing

Easy to use

No training necessary printing with MARKIPRINT X1JET HP is simple, due to 3-logic intuitive operation with LED status light, Data transmission is initialised with USB stick/in-

MARKIPRINT X1JET HP uses true type fonts for printing. All conventional 1- and 2dimesional codes can be printed. The controller is fully integrated into the print module. ◗ Highly compact design (see also picture in original size) Simple integration into packaging systems and conveyors for printing from the side or top ◗ Printing height upto 12.5mm

Control The system X1JET HP PRO allows data transmission via

USB stick. Each controller has a network connection (LAN) or a standard ETA-232 interface. Print layouts are created with iDesigns software. ◗ Data transfer using USB stick ◗ Data transfer connecting Ethernet ETA -232 ◗ Data transfer connecting to option interface ◗ (Printing communication from PLC or external photosensor) ◗ Data transfer enabling web interface Contact details MARK VI TRAC SYSTEMS Office No 11, ‘GIRNAR’ SV Road, Opp Police Station Dahisar (East) Mumbai 400 068 Tel: +91 -07738536663

Adaptable liquid chromatography systems for HPLC and UHPLC applications A LIQUID chromatography system is expected to deliver reliable results every day. What if requirements change, when for example a new application needs to be developed – how well can a system adapt?

The components of AZURA analytical liquid chromatography are combinable and highly adaptable. A level of modularity, rarely found elsewhere, makes it possible to adapt the system to almost any application. The eluent supply options range from standard HPLC to extended range HPLC Plus (max. 700 bar), up to UHPLC (max. 1000 bar) with optimised flow paths for sensitive and high resolution analysis. The pumps allow different gradient and solvent selection options. A choice of flow cells, including total reflection

and remote detection versions, different wetted materials, and a variety of instrument control options provide excellent application flexibility.

Contact details Chromline Equipment Company—Trusted For 25 Years!

To subscribe: bpd.subscription@expressindia.com

Unit 17 & 17A Ground Floor,Udyog Bhavan, Sonawala Road, Gorgaon(East), Mumbai 400063, India Tel. :+912226860816, +912261887317 Fax: +912226860306 Mail:vijay.more@chromline.in

EXPRESS PHARMA

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August 1-15, 2017

PHARMA ALLY

Clean room high speed doors a necessity NUMEROUS MANUFACTURING facilities require a controlled environment in which the amount of dust and dirt can be limited in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. You need to know the requirement for your specific product or process.

Clean rooms have become integral part of pharma manufacturing facilities.

One of the most important aspects of cleanrooms is the doors one choose for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc.

Opening and closure of door has to quick enough to isolate the outside environment and internal facility.

At Gandhi Automations,

clean room high speed doors are specifically designed for above purpose. He doors are best suited for facilities where controlled environment is re-

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

High Speed Clean Room

Doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with

positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h ?

50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, Off: +91 22 66720200 / 66720300 (200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

SHARP launches hi-tech air purifier with plasmacluster and dehumidifying function SHARP HAS launched its revolutionary air purifier DW-E16FA-W that combines dehumidifying function with plasmacluster technology. The launch heralds a major drive by SHARP to help breathe clean during monsoons by reducing the moisture in indoor air and effectively controlling allergens.

With coverage area of up to 300 sq feet for air purification and 240 sq feet for dehumidification, this super-efficient device maintains the humidity levels indoors while improving the air quality for those suffering from allergies or respiratory problems. The plasmacluster technology sanitises the living space by deactivating mold, viruses, dust mite and bacteria. It even reduces static charge and neu-

46 EXPRESS PHARMA August 1-15, 2017

tralizes VOCs and toxic gases.

Designed for today’s health conscious generation, Sharp DW-E16FAW is the only dehumidifier with plasmacluster ion generator with true hepa, active charcoal filter and pre filter for superior and holistic performance. This all-new approach to air purification helps combat the significant health risks during the monsoon.

The highest grade true HEPA filter removes dust, smoke and pollen up to 99.97 per cent. For bad odour and other smelly substances there is an active carbon filter embedded that freshens the room from both air and surface. In addition, the Laundry function deodorises room-dried laundry with a high concentration of plasmacluster ions.

PHARMA ALLY

Anchrom launches thin layer chromatography THIN LAYER chromatography is by far the most popular chromatography technique for qualitative and semiquantitative analysis, since the 1960s.

Over the years, TLC started to be performed instrumentally, overcoming some of the limitations, such as sample application as bands instead of spots, quantitative evaluation by densitometry etc. However, no SOP for HPTLC was ever established. This led to confusion between TLC and HPTLC, which led to

the SOP is still missing. HPTLC requires the above instrumentation plus control of all parameters that affect chromatography, which is where the USP SOP comes into play.

The moment of truth came on August 1, 2015 when USP Chapter 203 became effective. PhEur has adopted exactly the same SOP albeit in different words, in 2017.

Both TLC and HPTLC are pharmacopoeial procedures; however the fol-

HPTLC (USP SOP)

TLC

Software controlled chromatograph

No s/w or h/w

All parameters influencing results are controlled

No

Development in equilibrated chamber

No

Plate size - 20x10 cm

Plate size - 20x20 cm

Plate support materials – Glass, Al

Support materials – Glass, Al

Silica gel F254 (5 μm particles)

Silica gel F254 (10-30μm)

Layer activity (~33%RH) (Mgl2 sat.soln.)

No control

Sample band – 8x1 mm

Spot diameter – 2-10 mm

Sample position – 8 mm from bottom

– 15mm

Distance from side edge – 20 mm

N.A

Drying time - 5 min

variable

Max.no. of tracks per plate - 15

Max 12

Twin through chamber

Beaker or Flat or twin trough

Paper lining of chamber – A must

Usually no

Chamber saturation time – 20 min

Saturation time – 1-2 hrs

Development distance – upto 70 mm

Development – upto 150 mm

REGULATORY COMPLIANCE

REGULATORY COMPLIANCE

21 CFR 11 compliance

No

IQ – OQ – PQ

No

System Suitability Test

No

cGLP compliance

No

Electronic device for recording images under cGLP

No

Intensity markers

No

instrumental TLC being wrongly called as HPTLC. TLC is a manual method that uses devices designed in the 1960s and its methods cannot meet cGLP and other modern regulatory requirements. Instrumental TLC requires TLC software and instrumentation for sample application, chromatogram development, evaluation by scanner, chromatogram 'image' visualisation and documentation all controlled by one software. However,

lowing table shows the parameters that are required to be controlled in the two.

Column chromatography is to HPLC what TLC is to HPTLC! No procedure can become a regulatory method in trillion dollar trades unless numerous experts and authorities are satisfied about the quality of results.

The main drawback of instrumental TLC i.e. chromatographic development

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Continued on Page 48

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August 1-15, 2017

PHARMA ALLY

Moreschi Doors set up its base in Hyderabad ITALY-BASED Moreschi Doors, which is into manufacturing of industrial folding doors, industrial sliding doors, rapid roll up doors and rapid fold up doors, insulated rolling shutters manufactures industrial doors, has set up its manufacturing base in Hyderabad. It is a group company of Moreschi, Italy. Moreschi has 50 years of experience in technology and continuous innovation and has been a successful company now.

Moreschi Doors' services the Indian and Asian markets. All manufacturing machineries are imported from Europe and there is 100 per cent technical backup from Moreschi, Italy. All the technicians are trained in Italy to manufacture / install the doors The products are used in pharmaceutical and healthcare, air craft hangars, automobile industry,engineering industry, food industry, industrial production areas, logistics, service stations, ship industries, ware houses.

Folding door Speed door

Sliding door

Contact details Moreschi Asia Doors, Plot No 6, Shed No. 2, Anrich Industrial Estate, Ida Bollaram, Near Miyapur, Hyderabad â&#x20AC;&#x201C; 502325 Telangana

Anchrom launches thin...

Continued from Page 47 done in non-standardised manner in an open system has been completely eliminated by the development of an automated development chamber, in HPTLC HPTLC must not be looked through LC eyes. They are two separate techniques, each with its own strengths and limitations. Generally speaking, LC

48 EXPRESS PHARMA August 1-15, 2017

scores in a technical sense while HPTLC scores in practical sense.

Limitations of HPTLC include short separation bed (62 mm effective length), limited number of samples per plate, presence of silica gel during detection (unless MS is the detector). However, the advantages are too numerous, which are evident to an open and scientific mind. HPTLC is the fastest

chromatography method; result is visible both to detector and human eye, analyses 50-60 samples of five to six different types in parallel, has very low cost of analysis, negligible maintenance and a log machine life. HPTLC is shareable since it is not dedicated to any sample. Multiple detection modes like UV, Visible, Fluorescence, Bio-assay, MS, post-chromatographic derivatisation etc. can

be used without repeating chromatography. The sample cannot contaminate chromatograph. Cross contamination is impossible. Samples and standards are chromtographed in identical conditions. HPTLC instrument can be shared and there is no set-up time. Hyphenation with MS can produce several dozen MS per day. These are but a few advantages.

HPTLC is the ideal method

for first opinion on any organic, non-volatile sample.

Contact details Anchrom Enterprises (I) 101, A Wing, Aniket Apartment, Navghar Road, Mulund (E), Mumbai - 400 081, India.

Tel.: 091 22 21639928 31/7506792122 Fax: 091 22 21639927 E-mail : hptlc@anchrom.in

PHARMA ALLY VENDOR NEWS

Truking acquires Romaco shares A new laboratory will open up in China to support Romaco’s research and development activities in the area of process technology ROMACO GROUP recently completed sale of its shares to the Truking Group.From now on, 75.1 per cent of all Romaco shares will be held by Truking.

After concluding the contract of sale, the Truking management took the opportunity to introduce themselves personally to the Romaco workforce.

Romaco was officially taken over by Truking on June 30, 2017. As a result of the change in ownership, the Chinese Truking Group acquired 75.1 per cent of the total shares in the Romaco Group. The contract of sale with Deutsche Beteiligungs (DB) was signed on April 28, 2017. DB will surrender the remaining 24.9 per cent of its shares in Romaco to Truking within the next three years.

To mark the final transaction, Yue Tang, Chairman,

Truking and his delegation visited the Romaco production facilities in Karlsruhe (Germany) and Bologna (Italy). In his addresses to the workforce, he stressed his great admiration for Romaco and outlined the first steps in the cooperation.

More strategic acquisitions are planned as part of the drive to strengthen the Romaco portfolio. Parallel to this, the various Romaco sites will be successively expanded and enlarged. The initial planning phase for the construction of a new plant in Bologna has already begun. A new laboratory will open up in China to support Romaco’s research and development activities in the area of process technology.

Tang is adamant: “We’re ready to grow. Our aim is to take Romaco forward and increase our share of the global markets

More strategic acquisitions are planned as part of the drive to strengthen the Romaco portfolio.

Various Romaco sites will be successively expanded and enlarged

with a mixture of confidence, determination, patience and endurance.”

A camera team from ZDF, the German public broadcaster, accompanied the Truking delegation during their inaugural visit to Romaco Pharmatechnik in Karlsruhe while Italian TV stations Rete 7 and Nettuno TV reported on the Truking management’s address to the Romaco workforce in Bologna.

At the end of July, the entire Romaco management team will travel to Changsha, in the Chinese province of Hunan, for a one-week workshop at the Truking headquarters. The Romaco Group Management will visit Truking together with the managing directors of the various production facilities as well as the heads of the sales and service centres. Employee

representatives from Karlsruhe, Cologne, Steinen and Bologna will also be making the trip, which will provide valuable first impressions of the new parent company in China.

“Our experience of the Truking management so far has been thoroughly positive,” emphasised Paulo Alexandre, CEO, Romaco Group. “Despite the language barriers, communication with Truking has been extremely efficient and decision processes are very fast.

That widens our leeway to develop new strategies which will strengthen our position in the market. Now that the transaction has been brought to a successful conclusion, we’re looking forward to applying the measures adopted.”

EP News Bureau

Agilent Technologies acquires Cobalt Light Systems Cobalt’s solutions can analyse whole tablets or inside sealed containers reducing the need for quarantines and time-consuming sample processing and testing in pharmaceutical QC AGILENT TECHNOLOGIES has acquired Oxfordshire, UKbased Cobalt Light Systems (Cobalt), a provider of highly differentiated Raman spectroscopic instruments for the pharmaceutical industry, applied markets and public safety.

Cobalt’s innovative suite of benchtop and handheld/ portable Raman spectroscopic instruments are based on proprietary technologies that enable through-barrier identification of chemicals and materials.

Traditional solutions based on conventional spectroscopy have limited capacities for detection of materials through sealed,

non-transparent containers and are constrained to nearsurface identification of materials such as pharma tablet coatings and containers. By enabling measurement through opaque barriers and surfaces, Cobalt’s solutions can analyse whole tablets or inside sealed containers reducing the need for quarantines and time-consuming sample processing and testing in pharmaceutical QC, hazardous chemical ID and security. The result is significant time, cost, and resource savings for customers as well as increased safety for certain market segments such as first re-

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sponders or air passengers.

Cobalt’s customers include more than 20 of the largest 25 global pharmaceutical companies, and more than 75 airports across Europe and Asia-Pacific, including eight of the 10 largest European airports, with over 500 devices deployed at airport checkpoints. Recently, Cobalt has entered the hazardous substances markets with its handheld platform.

“Raman spectroscopy is one of the fastest-growing segments in spectroscopy,” said Phil Binns, VP and GM, Agilent’s Spectroscopy and Vacuum Solutions Division. “This acquisi-

tion gives our customers access to state-of-the-art Raman spectroscopy technology. It also provides Agilent immediate entry into this fast-growing segment with a highly competitive, differentiated offering.”

“This is exactly the type of acquisition that Agilent’s strategy calls for – one that expands our market share and provides immediate benefits to our customers,” said Patrick Kaltenbach, President, Agilent’s Life Sciences and Applied Markets Group. “We’re focussed on delivering best-inclass solutions to our customers, and Cobalt’s Raman

spectroscopy product and team meet and exceed that criterion.”“Cobalt and Agilent have similar cultures focussed on customer-centric innovation,” Paul Loeffen, CEO, Cobalt said. “The combination of Cobalt’s patented technologies with Agilent’s product-development expertise, manufacturing capabilities, channels and customer base will allow us to scale our operations to take advantage of this rapidly growing market.”

Agilent is acquiring Cobalt for £40 million in cash.

EP News Bureau

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49

August 1-15, 2017

PHARMA ALLY

Thermo Fisher Scientific and SRI International collaborate To enhance small molecule research THERMO FISHER Scientific, the world leader in serving science and SRI International, a research centre that creates world-changing solutions, announced the results of a collaboration agreement to enable researchers to combine the results of high-resolution Orbitrap LC/MS experiments with highly curated and organism-specific metabolic pathway and genome data for quick and effective mass spectrometry-based small molecule research and analysis.

The outcome of a success-

ful collaboration, researchers now have a direct link between the Thermo Scientific Compound Discoverer 2.1 software platform for small molecule research and SRI International’s BioCyc, a collection of 9,300 databases that provide electronic reference sources on the metabolic pathways and genomes of many organisms. The ability to automatically and interactively overlay statistical data onto these pathways can facilitate the biological interpretation of results obtained from a metabolomics experiment. Ul-

timately, this new link is expected to speed data analysis for compound discoverer users and enable them to visualise many individual compound measurements to gain a comprehensive understanding of biological processes in an experiment.

Today, metabolomics researchers can measure thousands of small molecules, but it can be challenging to know which cellular systems are behaving differently in the studied condition compared to a control,” said Andreas Huhmer, director, proteomics and

metabolomics marketing, chromatography and mass spectrometry, Thermo Fisher.

“The new integration will allow scientists using Compound Discoverer to automatically map the most detected compounds to BioCyc metabolic pathway diagrams, and to connect additional experimental data, such as relative abundance or differential expression, onto the pathways.”

“We are delighted to bring the power of BioCyc to Thermo Fisher’s customers through a system that’s intuitive and easy to use,” said Pe-

ter Karp, Director, Bioinformatics Research Group, SRI International. “Scientists can now follow a link from Compound Discoverer to a BioCyc metabolic pathway page to gain access to a comprehensive knowledgehub of genome and pathway information.”

Thermo Fisher and SRI International presented information resulting from the collaboration at the 13th Annual Conference of the Metabolomics Society, in Brisbane, Australia.

EP News Bureau

SCHOTT sets quality control standards for pharma tubing industry New technical performance specifications underline aspiration towards ‘zero defect’ glass tubing SCHOTT INDIA has presented new technical specifications to achieve unparalleled quality control standards for its FIOLAX pharmaceutical glass tubing manufactured in India. By harnessing big data through the implementation of its perfeXion system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 per cent of the tubing. As a result, SCHOTT now offers an improved product with superior auditability and traceability for the pharmaceutical industry. These improvements are anchored in the company’s new specifications and thus made visible for customers globally.

The new process has been introduced in all SCHOTT plants worldwide and will be applied to all FIOLAX tubes manufactured in its Jambusar plant. These technical standards are the culmination of years of in-house research

50 EXPRESS PHARMA August 1-15, 2017

into the development of tubing geometry measurement, suitable for SCHOTT’s fastpaced production environment. The tubing, used for vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning, even for parameters such as the inside diameter, which previously were difficult to meas-

ure. By improving the measurement of visual quality characteristics as well, SCHOTT can offer individual specifications tailored even closer to customers’ requirements.

In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, SCHOTT India has added specifications

for the precise measurement of circularity, siding, and straightness in these new standards. Furthermore, the minimum length restrictions for outside diameter and wall thickness tolerance deviations have been completely eliminated, the maximum permissible airline width has been reduced from 0.1 mm to 0.08 mm, and an extractables pro-

file for the glass composition has been added for the first time.

SCHOTT has also implemented a zero-defect tolerance for the following criteria: ◗ Maximum airline width of 0.08 mm ◗ Aggregate airline length depending on application ◗ Cracks ◗ Closed or missing DENSOCAN vent hole and its dimensions These standards are achievable with perfeXion, which uses state-of-the-art cameras and lasers to pinpoint potential defects along the production line, generating more than 100,000 data tags per minute and feeding them into a real-time production database. The process allows SCHOTT to automate inspection of 100 percent of tubes, while generating valuable data for potential improvements.

EP News Bureau

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With high performance comes design freedom.

A choice of 9 RAL colors to go with your brand image.

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Bangalore I Delhi I Guwahati I Hyderabad I Jammu I Kolkata I Mumbai I Vadodara I Sales@labguard.biz I www.labguard.biz Call National Hotline - 022 65650606

9 RAL colors available

The Reagent Racks featuring in this image is not a standard LabGuard product.

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Experiment With The Truth

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EXPRESS PHARMA Khurana & Khurana Advocates And IP Attorneys

International Symposium on Pharmaceutical, Biotechnology & Chemical Patent Laws with focus on ANDA Litigation, Para IV Strategies, Biosimilars, Regulatory Challenges, and Patent Prosecution Strategies in Europe, Japan, and Brazil THREE - DAYS INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL, BIOTECHNOLOGY & CHEMICAL PATENT LAWS For R&D SCIENTISTS & IP PROFESSIONALS

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Humidity Chamber

Cold Chamber

Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

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NEW AS 200 BASIC, DIGIT CA & CONTROL Vibratory Sieve Shakers

Particle Size Analysis with EasySieveÂŽ Software and CFR 21 Compliance EasySieve, the software for particle size analyses, exceeds manual evaluation in many aspects. n Automatic registration, evaluation and administration of measurement data n Measurement protocol inaccordance with standards n EasySieve CFR offers compliance with FDA 21 CFR Part 11 PRE MIUM QUA LI T Y MADE IN GERMANY

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WE ARE THE LARGEST MANUFACTURER OF PHARMACEUTICAL EQUIPMENT

Vertical Punch & Dies Storage Cabinet

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PHARMA LIFE BOOK REVIEW

The Act That Wasn't Dr Bobby George critiques both the lawmakers and law breakers in his book, The Act That Wasn't and manages to deliver on his promise of being 'an insider's view on healthcare laws, loopholes and reforms.' By Viveka Roychowdhury

W

ith an intriguing title like The Act that Wasnâ&#x20AC;&#x2122;t, author Dr Bobby Georgeâ&#x20AC;&#x2122;s book is sure to hook anyone who is researching the legal framework prevalent in India. Focusing on legislative measures impacting the healthcare and pharma sectors, the author also lays out the loopholes along with suggested reforms.

As Vice President & Head Regulatory Affairs, Reliance Life Sciences, the author has spoken on these topics at various fora and has published in quite few journals. This book adds to his already sizable work on this subject and manages to delivers on its promise of being 'an insider's view on healthcare laws, loopholes and reforms'.

Published in March this year, with a foreword by Justice KT Thomas, former Judge of the Supreme Court of India, and testimonials from Dr Eswara Reddy, Joint Drugs Controller of India and Dr YK Gupta, Prof & Head, Department of Pharmacology, AIIMS, New Delhi, the book comes highly recommended by some of the doyens who have been involved with shaping the very laws and their implementation that George critiques in his book.

As Dr Gupta points out, the author describes the background and details of the Acts (laws) put in place, as well as reviews the acts (wrong deeds) of the industry. He also details how regulators have engaged with stakeholders while formulating these policies and regulations.

Priced at around ` 400 and accessible on e-commerce sites, the slim volume consists of 12 chapters, each focusing on key

To subscribe: bpd.subscription@expressindia.com

legislation ranging from the Clinical Establishment Act to fixed dose combination drugs and biosimilars. It also analyses laws regulating referrals, surrogacy, organ transplants, etc.

While analysing the nuances of the Acts, the book also details the unsavoury practices that the laws seek to control.

For instance, in the fourth chapter titled Blood Borne Acts, the author starts with the technicalities of blood banking and transfusion, then goes on to detail the menace of unlicensed blood banks, the shortage and wastage of blood products even as there is rampant 'trading in blood/components/plasma' and overpricing. George ends each chapter with recommendations to government on how the laws can be strengthened as well as some advice to industry stakeholders. The common refrain, not very different from other writers on this subject, is that while the laws are in place, their implementation lacks sustained and systematic vigour. But this is a book that will hopefully trigger renewed effort from both regulators and industry to meet on the same page and protect the interests of the patient.

The author's exhaustive analysis of global laws, juxtaposed with the scenario in India, will prove to be invaluable to both industry professionals tasked with compliance within their organisations. It will also serve as a research guide for health policy researchers as well as students hoping to make a career for themselves in this vital yet much abused sector. viveka.r@expressindia.com.

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PHARMA LIFE AWARDS

Biocon Foundation’s eLAJ project wins award Biocon Foundation’s eLAJ programme was selected as it is an ‘initiative that had the biggest health outcome bang for the buck and effort expended and serves as an inspiration to other organisations whose CSR work is in the area of health BIOCON FOUNDATION, the CSR arm of Biocon, received the Health CSR Project of the Year award for its outstanding contribution to strengthening primary healthcare delivery in India through its eLAJ platform for the benefit of communities with poor access to healthcare.

Dr Suchitra Bajaj, Senior Program Manager, Biocon Foundation, received the award at the first annual edition of the CSR Health Impact Awards 2017 recently held in New Delhi.

Biocon Foundation’s eLAJ programme was selected as it is an ‘initiative that had the biggest health outcome bang for the buck and effort expended and serves as an inspiration to other organisations whose CSR work is in the area of health.’

Kiran Mazumdar-Shaw, Founder and Managing Trustee, Biocon Foundation, said, “I am pleased that Biocon Foundation’s eLAJ initiative has been bestowed the ‘Health CSR Project of the Year’ Award. At Biocon Foundation, we strongly believe that the use of technology can address the challenges

Dr Suchitra Bajaj, Senior Program Manager, Biocon Foundation receives the award from Dr Dharminder Nagar, MD, Paras Healthcare and Kamal Narayan, Director, for India Health and Wellness Foundation

associated with public health delivery in our country. We have taken ahead this belief to develop the unique eLAJ model to facilitate effective preventive and primary healthcare intervention for marginalised com-

munities living in underserved urban and rural areas of India.

Through eLAJ smart clinics we aim to ensure the ‘Right to Health’ for these communities.”

As early adopters of technology, Biocon Foundation devel-

oped a unique e-healthcare model and introduced the first eLAJ Smart Clinic in Karnataka in 2015 to plug the gaps in public health delivery. The eLAJ Smart Clinics have state-of-theart diagnostic equipment, clinic

and patient management software along with trained doctors and technicians. The model has been designed to deliver databased healthcare on the basis of socio-demographic and health indicators obtained from community-based screenings.

Biocon Foundation currently runs 14 eLAJ smart clinics covering over 30 gram panchayats across Karnataka and Rajasthan. These clinics are paving the way for evidencebased public health interventions in these locations by enabling multiple diagnostic tests and generation of Electronic Medical Records (EMRs) of patients. They are facilitating on-time treatment, helping reduce out-of-pocket healthcare spending and cutting down the need for trips to tertiary hospitals.

In addition to providing patients access to more effective diagnosis and treatment, eLAJ clinics also offer a wide range of preventive medical and earlydetection programmes run by the Foundation.

EP News Bureau

Agilent Technologies presents thought leader award to Dr Ram Sasisekharan Dr Sasisekharan was recognised for advancing the use of analytical techniques and multilayer analysis for characterisation of biopharmaceuticals AGILENT TECHNOLOGIES announced that Ram Sasisekharan, has received an Agilent Thought Leader Award in recognition of his contributions in the field of biologics characterisation.

The Agilent Thought Leader Award will help Dr Sasisekharan and his lab at the Massachusetts

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Institute of Technology (MIT) in Boston, continue to evolve their radically different approach that aims to shorten the development time between product ‘design’ to the clinic. The proposed approach represents a new paradigm, characterising and optimising both the product and the process in a highly rich, parallel

and multilayered fashion.

Agilent’s 6545XT AdvanceBio LC/Q-TOF System, AssayMAP Bravo Platform (sample preparation solution), 1260 Infinity II Bio-Inert LC System combined with the 1290 Infinity II LC System, and MassHunter software will be used to help enable this new paradigm.

Sasisekharan’s team will focus on the advancement of analytical techniques for mAb characterisation to explore the utilisation of critical quality attribute measurements, earlier in the clone selection and drug development process, as a strategy to bring biologics to market faster.

EP News Bureau

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