Express Pharma (Vol. 10, No. 4) December 16 - 31, 2014

VOL. 10 NO. 4 PAGES 56

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Cover Story A pricey issue Market ‘India needs to build capacity across the board’ Express Pharma wishes all its readers a Happy New Year

16-31 DECEMBER 2014,` 40

CONTENTS MARKET Vol.10 No.4 DECEMBER 16-31, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

ENGAGING THE NEW AGE EMPLOYEE

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‘INDIA NEEDS TO BUILD CAPACITY ACROSS THE BOARD’

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CCI APPROVES RANBAXY ACQUISITION BY SUN PHARMA

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SUVEN LIFE SCIENCES RAISES `200 CR THROUGH QIP

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

The role of an HR department is pivotal for anycompany’s success.

Yet,employee engagement programmes tend to be out of sync with the aspirations of the newage employee | P46 P24: RESEARCH INTERVIEW ‘The government could do more, in terms of how it sees research activities’

MANAGEMENT

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BRISTOL-MYERS SQUIBB FOUNDATION AWARDS NINE GRANTS TO INDIA AND CHINA

P25: CLINICAL UPDATES AstraZeneca and Lilly move Alzheimer’s drug into big trial

P26: RESEARCH UPDATES

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FDA panel recommends approval for Actavis’ antibiotic drug

P29: VENDOR NEWS NMR spectrometer boosts Wacker’s local expertise at R&D facility in Kolkata

P52: AWARD ‘Innovation & Excellence’ sweep India Pharma Awards 2014

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THE ‘COUNTERFEIT’ CONUNDRUM IN PHARMA INDUSTRY – IS IT TIME FOR CONCERTED ACTION?

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DRL’S UNIT RECEIVES US FDA OBSERVATIONS ON POSSIBLE LAPSES

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CPHI & P-MEC INDIA 2014 CONCLUDES IN MUMBAI

RECENT CARDIOVASCULAR CLINICAL TRIALS FRAMING DEBATE ON PERSONALISED TREATMENT: GLOBALDATA

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EDITOR’S NOTE

Learnings from the GVK BIO saga

N

ow that India’s competition watch dog, the Competition Commission of India (CCI) has given its nod to Sun Pharma’s acquisition of Ranbaxy, will we see similar deals among other promoter driven pharma companies in India? Many pharma promoter families have diversified interests today, which speaks of their entrepreneurial zeal but it is also true that with increasing regulation and price control, the pharma sector is getting less attractive.

(See cover story, ‘A pricey issue’, pages 18-21) Today, pharma companies from India are no longer minnows in the global pond, but there are obviously bigger fish fiercely guarding their turf.

Pharma MNCs have their own existential problems. A GlobalData study predicts that they will suffer an estimated $65 billion drop in sales by 2019 due to patent expiries of several leading drugs.

Besides turf wars with pharma peers, global regulators too are ratcheting up their benchmarks.

They are more connected to each today than in yesteryears, with regular sharing of information and results from inspections. And action by one automatically puts a company on the watch list of the others. Take the most recent case of Hyderbadbased CRO GVK BIO being accused of “serious and systematic deficiencies” in the bio-equivalence (BE) studies it conducted for companies in the EU markets.

EMA’s Committee for Medicinal Products for Human Use (CHMP) found that GVK BIO's BE studies conducted at its Hyderabad clinical development facility since 2008-2014 were not sufficient to support Marketing Authorization Holders (MAHs). The EMA cited a previous inspection by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), France's National Security Agency of Medicines and Health Products, which had concluded that some GVK BIO employees had taken print outs of ECGs from one volunteer and used them for other volunteers. Even though GVK BIO got reports from four cardiologists which indicated that the check-out ECGs could belong to multiple volunteers and it was difficult to conclude that they belonged to the same volunteer, the French inspector concluded that the studies did not meet the Good Clinical Practices (GCP) guidelines and

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What is eminently clear from this chain of events is that global regulators will not tolerate even a shadow of doubt when it comes to safeguarding the health of their citizens.Clearly,this is a continuation of the backlash from a rash of GMP violations,which were first denied or covered up

should be rejected.

The EMA's CHMP's reasoning was that since some of the same employees involved in check-out ECGs could be involved in other critical activities, it left an element of doubt on the BE results.

Germany's regulator, The Federal Institute for Drugs and Medical Devices, soon followed suit after its own investigations.

GVK BIO insists that it was a matter of interpretation and points out that check-out ECGs are conducted before volunteers leave the clinic merely as an additional safety test, and do not form part of any international clinical trial guidelines. The statement leads one to believe that the check-out ECGs were an additional precaution taken by GVK BIO to ensure that volunteers are safe on key health parameters before leaving the site and were not taken as a drug efficacy parameter, and may have no direct relevance to the quality of the testing of drugs.

The CRO also quotes from the ANSM's website where it has been stated that the decision was taken as a precaution and no element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs. It has agreed to redo the trials but stands by its protocols. Of the nine studies randomly chosen for a review by the French inspector, not all required ECG monitoring, but according to a GVK BIO spokesperson, checkout ECGs are done on all its volunteers, as matter of its internal protocols.

What is eminently clear from this chain of events is that global regulators will not tolerate even a shadow of doubt when it comes to safeguarding the health of their citizens. Clearly, this is a continuation of the backlash from a rash of GMP violations, which were first denied or covered up. What it also means is that pharma companies (and CROs for that matter) from India will have to ensure that their protocols measure up to global standards and scrutiny. And that each employee follows the protocol to the T. Pharma companies are waking up to the need to engage proactively with employees. (See story: Engaging the new age employee, pages 46-50).

Winning back the trust of global regulators will be tougher and GVK BIO’s experience will no doubt have lessons for all of us.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘India needs to build capacity across the board’ Stephen M Sammut, Senior Fellow, Health Care Management, Wharton School, University of Pennsylvania and Visiting Faculty, Indian School of Business in an interaction with Shalini Gupta talks about the state of VC environment in India's biotechnology sector How has the VC environment in biotechnology fared over the last few years globally?

What changes and trends do you see?

The venture capital environment has become difficult to describe. The absolute number of professionally managed venture funds that focus on biotech and healthcare has actually declined globally over the last few years, but at the same time, the availability of capital from angel sources has increased.

The US investment from venture capital funds for biotech, medical devices and healthcare services during the first three quarters of 2014 exceeded $6.5 billion, a figure that compares favourably with recent years.

For India, during the first three quarters of 2014, investments approach $1 billion for the same industrial categories, but this includes money invested by private equity funds and reflects mostly health services. While it would be extreme to say that biotech is an orphan in terms of venture financing in India, that wouldn’t be far from the truth. This situation is definitely a drag on the growth of India’s biotech industry. In the case of India, there are not many forces at work that are driving that number upwards.

Has funding in biotech increased vis-a-vis sectors such as IT? What role

do you see big pharma playing here?

Investments from VC and PE funds in IT in India have been running more than double the investments in life sciences and healthcare.

Given the preeminence of India IT you would expect there to be more of a gap.

The two sectors are independent of one another but there is a need for more risk capital in both industries. With respect to the pharma industry providing more investment in Indian biotech, there have been a steady number of strategic alliances between European, the US and Japanese companies with Indian pharma and biotech companies, but there is need for these to occur more frequently and in larger amounts of financing.

Where does India stand?

What are the opportunities and challenges?

Given the remarkable evolution of the Indian pharma industry over the last 40 years and the full range of capabilities that India offers in order to propel biotech, the pace of growth has been below the potential.

There is the possibility of a more rapid acceleration of the biotech industry if a number of factors change.

These are not solely related to available capital. There are issues related to the regulation of pharma, technology transfer, intellectual property and

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While it would be extreme to say that biotech is an orphan in terms of venture financing in India, that wouldn’t be far from the truth standards for clinical trials that directly impinge on the growth of the sector.

Attention is needed on all of these factors.

Where does India stand on the biotech map globally?

How do we compare to other emerging markets, particularly in South-East Asia? What capacities do we need to build yet?

In a paper that I co-authored in the New England Journal of Medicine earlier this year, we did a comparison of research funding trends on a global basis. While India’s public and private investment in 2012 reached $2 billion for life sciences, this paled in comparison to the West, which is no surprise.

However, in the same year, the public and private investment in life sciences in China was $8.4 billion and $6 billion in Korea. Other Asia-Pacific countries spent an amount similar to India.

There isn’t necessarily a correlation between the amount of funding and quality research, but there is obviously a funding gap between India and other Asian countries. As intimated above, there is progress underway in regulation, IP, tech transfer and clinical trials in these same markets. India needs to build capacity across the board.

Are the investors of today more interested in small biotechs vis-a-vis MNCs? What opportunity do they present? Are these small biotechs with promising products also coming out of markets apart from the US?

The investment community has been focused on the emerging biotech companies for several decades. The MNCs attract attention when a potential new block-buster is in development, but the main story is on the innovation brought to the scene by the biotechs. Tackling the global disease burden of both communicable and non-communicable diseases is the province of the biotech companies. By and large, the MNCs have effectively outsourced discovery and development of new medicines to the biotech industry and to some extent, to universities. Not so long ago, the US dominated the biotech scene, but this is changing rapidly. Biotech companies are now being built around university technology throughout the world, although we don’t see very much of that occurring in India, partially because there is a limited infrastructure to manage the process and a legal framework that must still be put into place.

Innovation is driven by entrepreneurs. What is the current level of entrepreneurship in biotechnology and pharma across the world? What are the enablers for a thriving entrepreneurial ecosytem?

How do you see India when it comes to this?

Continued on Page 12

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MARKET

COMPANY WATCH

CCI approves Ranbaxy acquisition by Sun Pharma Sun Pharma and Ranbaxy had filed the notice with the CCI on May 6, 2014 and sought its approval with respect to the deal SUN PHARMACEUTICAL Industries and Ranbaxy Laboratories have received the order of the Competition Commission of India (CCI) dated December 5, 2014 by which CCI has approved the acquisition of Ranbaxy by Sun Pharma, subject to compliance with certain conditions.

Sun Pharma and Ranbaxy had filed the notice with the CCI on May 6, 2014 and sought its approval with respect to the deal. Over the past few months,

the CCI has sought information and detailed clarifications for the purposes of making its assessment. One of the preconditions of the order is that parties procure the divestment of seven products. These products constitute less than one per cent of the combined entity’s revenues in India.

Dilip Shanghvi, Managing Director, Sun Pharma said, “The order of the CCI approving the deal is an important milestone

A precondition of the order is that parties procure the divestment of seven products

for the transaction. It revalidates our view that the Sun Pharma and Ranbaxy businesses complement each other with limited product overlap, and will offer a comprehensive product basket to enable future growth. We are pleased with the open and transparent manner in which the matter has progressed.”

Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy said, “The approval

by CCI is a significant step for-

ward. We are confident that post closure, the combined entity will enable sustainable long-term growth and deliver immense value for all stakeholders.”

Sun Pharma and Ranbaxy are looking forward to progressing towards the completion of the transaction and will comply with the conditions laid down by the CCI within the specified time.

EP News Bureau- Mumbai

Sigma Aldrich shareholders approve merger with Merck

Aurobindo completes the acquisition of Natrol

78 per cent of Sigma-Aldrich shareholders approve transaction

AUROBINDO PHARMA announced the completion of acquisition of assets of nutritional supplement maker, Natrol Inc. and other affiliate entities (Natrol) through its wholly owned subsidiary Aurobindo Pharma US Inc (APUSA). APUSA emerged as the highest and best bidder to acquire assets of Natrol under the auction process by the US bankruptcy court for the district of Delaware.

APUSA acquired the Natrol’s manufacturing assets, personnel, and commercial infrastructure including the nutraceuticals brands in the US along with an agreement to take on certain liabilities, with a bid of $132.5 million.

The assets have been acquired under a wholly owned subsidiary, Nature Acquisition LLC and since changed to Natrol LLC. APUSA expects the profitability to improve by combining the strength of both enterprises in creating a fully integrated nutraceuticals platform in the US and other

MERCK RECENTLY acquired US-based life science company Sigma Aldrich. Sigma Aldrich’s shareholders approved the merger with Merck at a special meeting held at the Sigma Aldrich Life Science and Technology Center in St Louis, Missouri, US. With approximately 78 per cent, shareholders owning the required majority of the outstanding shares of SigmaAldrich approved the proposed transaction. Shareholder approval was one of the conditions the transaction is subject to.

According to the merger agreement, publicly announced on September 22, 2014, Merck will acquire all of the outstanding Sigma-Aldrich shares for $140 per share in cash. Merck continues to expect the transaction, which is subject to regulatory approvals, to close in mid-year 2015. Merck is working closely with the respective authorities

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Merck will acquire all outstanding Sigma-Aldrich shares for $140 per share in cash to ensure a seamless transaction. The acquisition had already unanimously been approved by Sigma-Aldrich’s Board of Directors in September 2014.

In September, Merck and Sigma-Aldrich announced that they had entered into a definitive agreement under which Merck will acquire Sigma-Aldrich for $17.0 billion (€13.1 billion), establishing one of the leading players in the $130 billion global life

science industry. The acquisition is a key element in Merck’s ‘Fit for 2018' transformation and growth programme aimed at three growth platforms, healthcare, life science and performance materials.

The combined company would serve life science customers with a set of established brands and a supply chain that can support the delivery of more than 300,000 products. In the laboratory and academia business, Merck Milliampere and Sigma-Aldrich would offer their customers a range of products across laboratory chemicals, biologic and reagents. In pharmacy and pharmacopoeia production, Sigma-Aldrich would complement Merck Millipede’s existing products and capabilities with additions along the entire value chain of drug production and validation.

EP News Bureau- Mumbai

international markets.

Mesrop Khoudagoulian, Natrol Chief Executive Officer commented, “I am pleased that Aurobindo recognises the values of Natrol’s uncompromised quality products, loyal customers, talented employees and solid relationships with our retailer partners. We look forward to working with the Aurobindo team to further expand our over-the-counter product portfolio and our reach with the financial support of strong owners.”

N Govindarajan, Managing Director, Aurobindo stated, “Natrol comes with certain well established brands and an extensive distribution network consisting of retail pharmacy chains and specialty health food stores, to help us tactically position ourselves in the US nutraceuticals space and offer an effective growth strategy to expand market penetration going forward.’

EP News Bureau- Mumbai

MARKET

Suven Life Sciences raises `200 cr through QIP The company accordingly will issue 1,04,53,690 equity shares of face value of `1 per equity share at a price of `191.32, including a premium of `190.32 per share SUVEN LIFE Sciences has concluded its `200 crore fund raising exercise through the Qualified Institutions Placement (QIP) process. Anand Rathi Advisors acted as the sole global co-ordinator and book running lead manager for this QIP. The transaction saw participation by some highly reputed investors in India. The company accordingly will issue 1,04,53,690 equity shares of face value of `1 per equity share at a price of `191.32, including a premium of `190.32 per share. Post issue the promoters holding will be in excess of 59 per cent as against 64.76 per cent on September 30, 2014.

Venkat Jasti, Chairman, Suven Life Sciences said, “This is our public raise after 10 years since our preferential issue during 2004. The Anand Rathi team and we were able to successfully communicate our unique business model which has been validated and acknowledged by the fantastic response that we have received. One of the strategic objectives of this deal was to get the right set of long-term investors of high credibility and the willingness to back the long-term business plan of our company. I believe the Anand Rathi team has delivered on that objective.

We are now set to enter into a new and more exciting phase of growth.”

Amit Rathi, Managing Director, Anand Rathi Advisors said, “The response to this transaction, including the pedigree of investors, has been fantastic.

This sets up the company to catapult itself into the next exciting phase of growth.”

The funds raised will be effectively deployed to fund the clinical development programme, capital expenditure and for general corporate purposes.

EP News Bureau- Mumbai

EXPRESS PHARMA

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December 16-31, 2014

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Bristol-Myers Squibb Foundation awards nine grants to India and China Totalling more than $3.5 million, the grant will support care for high-risk patients with Hepatitis B & C THE BRISTOL-MYERS Squibb Foundation announced nine new grants totalling more than $3.5 million to strengthen efforts in India and China in the fight against hepatitis B virus (HBV) and hepatitis C virus (HCV) infection by focusing on the most vulnerable, high-risk patient populations. The multiyear grants were made through the Foundation’s Delivering Hope initiative, which has supported more than 40 projects in India and China since 2002.

These new grants align with the WHO strategies for reducing the incidence of HBV and HCV infection through early diagnosis and screening of highrisk populations, including intravenous drug users and patients co-infected with HIV and/or tuberculosis. Several focus on increasing awareness about disease transmission among healthcare providers who care for HBV- and HCV-infected patients, who also are considered at-risk for contracting viral hepatitis.

“Delivering Hope continues to increase its focus on HBV and HCV in India and China, the

The multi-year grants were made through Foundation’s Delivering Hope initiative, which has supported more than 40 projects in India and China since 2002 two countries that have the highest incidence of viral hepatitis worldwide,” said John Damonti, President, Bristol-Myers Squibb Foundation. The following projects in India received the grants: All India Institute of Diabetes and Research: A pilot programme in Mehsana and Sabarkantha, two rural districts in the state of Gujarat that have experienced HBV outbreaks, will expand HBV testing in public healthcare institutions, make vaccinations more widely available through a network of non-governmental organisations and hospitals, and train health care practitioners on injection safety and universal precautions against HBV. MAMTA: Healthcare

providers, including doctors, nurses, lab technicians and others who come into direct contact with hepatitis patients, will receive training in HBV and HCV risk assessment, disease prevention and risk management. Community-based programmes will target high-risk groups, including intravenous drug user and their partners, pregnant women and newborns. A health card will be issued to all high-risk populations to track their navigation to comprehensive health care services.

United Way of Mumbai: To help prevent disease in the hardest-hit and most-at-risk populations, medical interventions and extensive community education will take place in 18 slum areas in Mumbai. The

project will adopt HOPE Initiative’s Center of Excellence School Health Program to educate students and their families about HBV prevention and control.

SAMARTH: As new grantees join the Foundation’s Delivering Hope initiative in India, proper monitoring and evaluation will ensure that programme goals are achieved. SAMARTH will conduct training activities to strengthen partners’ ability to self-monitor and evaluate their programme’s progress and provide objective information about program functioning, methodologies, effectiveness and impact, and identify potential gaps.

World Hepatitis Alliance: They will develop a new model of patient group creation aimed

at physicians who treat viral hepatitis and engage them in creating and sustaining patient support groups.

The World Hepatitis Alliance will develop an e-learning tool comprising a video course and a text-based tool kit that will focus on the importance of advocacy to promote viral hepatitis awareness and prevention, the need for patient groups to be integral to advocacy, advantages to physicians of having strong patient groups, provide information about creating a patient group and supporting existing groups and map out support available from the World Hepatitis Alliance and other sources.

These learning materials will be housed on the World Hepatitis Alliance website and will be available to be hosted on other websites, including those operated by major international hepatology societies, to ensure wide distribution. The project will include China and India, but is more broadly aimed at the world.

EP News Bureau- Mumbai

Pfizer concludes merger with Wyeth Zydus launches Adalimuma Files order with the Registrar of Companies to conclude the merger process PFIZER ANNOUNCED the completion of the merger with Wyeth. The company had received approvals from the Bombay High Court earlier and has filed the order with the Registrar of Companies to conclude the merger process. The merger places Pfizer among the top 10 pharmaceutical companies in India by market share. Pfizer,USA, through its subsidiaries holds the majority stake in both com-

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panies and will continue to remain the majority shareholder with an approximate 63.9 per cent holding in Pfizer, postmerger.

As a result of the merger, Pfizer now has a significantly stronger portfolio of offerings across a wider therapeutic universe. Importantly, the company now debuts its offering in vaccines with India’s largest vaccine brand and builds a robust pres-

ence in the areas of women’s health with a portfolio that includes some of the best known brands in oral contraception and folic acid supplements.

With the conclusion of the process, all employees of Wyeth are also now a part of Pfizer. The company has already completed the necessary steps to ensure a seamless transition and integration of the workforce into Pfizer.

EP News Bureau- Mumbai

ZYDUS CADILA announced the launch of its biosimilar Adalimumab, following an approval from the Drug Controller General (India).

According to a press release, the biosimilar was developed by researchers at the Zydus Research Centre. To be marketed under the brand name Exemptia, it will treat autoimmune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis.

Though it is estimated that

more than 12 million patients in India suffer from these chronic conditions which progressively deteriorate and lead to lifelong pain and in some cases, even disability, Adalimumab, the fully human anti-TNF alpha monoclonal antibody, was not available to patients in India.

Zydus has also announced that it will offer a dedicated Exemptia Care support programme to patients and caregivers.

EP News Bureau- Mumbai

MARKET

DRL’s unit receives US FDA observations on possible lapses The US Food and Drug Administration (US FDA) has found what it calls nine “inspectional observations” at Unit VI of Dr Reddy’s Laboratories THE US Food and Drug Administration (US FDA) has found what it calls nine ‘inspectional observations’ at Unit VI of Dr Reddy’s Laboratories’ Srikakulam plant. The apex regulator has through Form 483 sought explanation on the nine observations that are said to be procedural.

The plant, which manufactures active pharmaceutical ingredients (APIs) and bulk drugs, was recently visited by US FDA. Form 483 is used by the FDA to document and communicate concerns discovered during these inspections.

“We have received nine inspectional observations from the US FDA after their visit to our API manufacturing facility in Srikakulam district. We will respond to the agency within stipulated timelines with our remedial plans and start implementing the necessary measures immediately,” the company said in an emailed response.

“These observations largely relate to procedural and other compliance of the plant systems. At this stage, production continues in the normal course and there is no

The plant, which manufactures active pharmaceutical ingredients (APIs) and bulk drugs, was recently visited by US FDA implication on any activity at the plant,” a company official said. Dr Reddy’s also said it cannot comment on the number of Forms 483 received in the last 203 years. However, as

a result of this audit, no production has been effected, it said.

“The 483 observations are unlikely to affect the production of the company and,

therefore, it will continue as per normal routine,” Sarabjit Kour Nangra, VP – Research Pharma, Angel Broking, said.

FE had reported about the surprise check by the regulator at the chemical technical operation (CTO) unit VI, which manufactures both active pharmaceutical ingredients (APIs) and bulk drugs.

The unit, set up in 1990, has a reaction volume capacity of over 570 KL, and is US FDA inspected and ISO-9001 certified.

FE Bureau

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MARKET Continued from Page 7

‘India needs to build...

In addition to entrepreneurs as drivers of innovation, we also have to look at universities, especially in biotech.

Investors would rightly argue that experienced and proven entrepreneurs are still the scarcity that slows down growth of the industry. This is arguably true but at the same time, there are now upwards of 10,000 biotech companies globally, all with someone serving as founder and CEO. The talent still must mature, but there is an army of capable people committing themselves to the industry.

The ecosystem is dependent on all the issues we’ve discussed so far: ample supply of smart capital, a sound and equitable IP system, a mechanism for reliable technology transfer, a regulatory framework suitable and flexible for new opportunities, and a clinical trials infrastructure. There are other factors, as well.

There is a growing body of research that suggests that companies in countries with a base of early adopters

and consumers with the capacity to buy new products will have a competitive advantage. This, of course, becomes entangled in the issues surrounding the pricing of medicines, but companies that have to rely on off-shore markets for sales at premium pricing have major strategic challenges.

Finally, development of entrepreneurs through training and education, and a culture tolerant of risk are key ecosystem factors.

Tell us something about the project on global technology transfer with IFC and its pilot project focused on India. How do you see technology transfers playing a major role especially when it comes to making drugs more affordable and accessible to the masses?

What would drive this in the future?

The IFC Technology Transfer Facility is playing a key role in promoting incubation of new ideas. I was actually involved in the

I am not sure there is a direct connection with the problem of medicinal access and affordability conceptualisation of that programme a few years back.

Technology transfer as a process will help stimulate the creation of new businesses and the expansion of capacity and industries, but I am not sure that there is a direct connection with the problem of medicinal access and affordability. The tech transfer process can certainly help bring new medicines for neglected diseases to the market. Theoretically, if these medicines are discovered and pioneered within the

emerging markets, their development costs would be far less and therefore, the pressure on high prices in order to recover development costs would be less. But that isn’t necessarily a given.

Access to medicines is an issue that is critical for humanity, but it is a complex problem that will require a multi-faceted set of solutions.

What is the future of biotech VC firms? Also, do you see more co-working spaces like Genspace in New York and the Open source Drug discovery network at CSIR, India, driving innovation in the future?

Personally, I am not so sanguine about the future of specialised biotech VC firms.

There is a disconnect between the way that these funds are structured, how they must manage investments and the expectations of their own investors that are all misaligned with the realities and time frames of medicinal discovery and development. A new model

will necessarily emerge. It may take the form of holding companies that are structured for longer time frames, or some other form, but I am not convinced that the model that has been in place for the last 40 years will serve us for the next 40 years.

With respect to innovation, different approaches to open innovation and collaboration are certainly a necessity in future medicinal discovery and development. It is still too early to tell, however, whether structured programmes like these will have the translational research capacity and the organisational ethos to bring products through at least the early stages of development. The reality is that at some point, the funding and development of a new medicine will have to be assumed by a commercial entity that is focused on bringing the products to clinical reality and is rewarded in some appropriate way for doing so. shalini.g@expressindia.com

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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 Limited, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

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

MARKET PRE EVENT

BioAsia 2015 to herald ‘Opportunities in the Transition’for life sciences and healthcare industry 12th edition of the conference in Hyderabad will have seven focus areas THE 12TH edition of the annual international lifesciences conference, BioAsia 2015 will unveil the ‘New Opportunities in the Transition’ in the field of life sciences and healthcare industry. BioAsia 2015 will be held in Hyderabad from February 2 to 4, 2015.

BioAsia 2015 is organised by the Federation of Asian Biotech Association (FABA) and the Pharmaceutical Export Promotion Council (Pharmexcil) with the support of State Government and the Government of India. Public Health Foundation of India (PHFI), PricewaterhouseCoopers (PwC), Biotech Industry Research As-

BioAsia 2015 is organised by FABA, Pharmexcil, PHFI, PwC, BIRAC, TiE-Hyderabad, OPPI, NIMS, IMA, FICCI – Food 360, ACRO, Aurigene Discovert, Invest India, India Brand Equity Foundation among other organisations will be working in partnership sistance Council (BIRAC)-GoI, TiE-Hyderabad, Organization of Pharmaceutical Producers of India (OPPI), Nizams Institute of Medical Sciences (NIMS), Indian Medical Association (IMA), FICCI – Food 360, Association of Contract Research Organizaions

(ACRO), Aurigene Discovert, Invest India and India Brand Equity Foundation among other organisations will be working in partnership to organise this event on a grand scale.

BioAsia 2015 will include conferences and expert ses-

sions, CEO conclave and workshops on following topics ‘Drug Discovery and India’s Innovation Pipeline’, ‘Digital Health and Healthcare IT’, ‘Clinical Research’, ‘Supply Chain and Logistics’, ‘Rapid Diagnostics’ ‘Medical Electronics and Devices’, and ‘Public

Health & Access’ along with international tradeshow, networking receptions, BioAsia connect and BioPark visits.

Shakthi Nagappan, Chief Executive Officer, BioAsia said, “BioAsia 2015 will be organised with the theme of new era of life sciences to symbolise the transitioning phase of opportunities in India and also contribute to the country’s economic revival agenda. The event is designed to offer the right opportunities to catch the right notes and develop strategies to succeed in emerging markets like India.”

EP News Bureau-Mumbai

MARKET POST EVENT

CPhI & P-MEC India 2014 concludes in Mumbai Expo attended by over 30,000 delegates from across the globe CPHI INDIA, P-MEC India and ICSE, the three-day pharma industry event, was recently held in Mumbai. The first day of the event witnessed over 1000 plus exhibitors from over 100 countries. The expo is likely to be attended by over 30,000 delegates from across the globe.

The event was inaugurated

by Sudhanshu Pandey, Joint Secretary, Dept. of Commerce, Government of India. In his address, he said, “Platforms like these recognise people and motivate them to do better while continuing to inspire others. The last few years have been tough on the pharma sector due to various issues and challenges with regards to regulatory norms. But we must address these challenges in the right spirit. It’s a long way for the Indian pharma industry, but we are on the right track.

India today boasts of world class facilities. The road may be tough but we have what it takes to get there.”

Pandey also shared some of the (Indian) government’s plans to boost the industry.

He mentioned that the government is trying to make regulations more stringent and is also working on minimising/simplifying the process. The government is trying to understand the industry issues and is willing to work on it. He pointed out that there has been a dip in India’s pharma exports and indicated that the government and the DGFT are finalising different policies to reverse this slide. He assured industry attendees that the government has allocated sufficient funds for resource deployment and creation of infrastructure in the current year and concluded that if these are utilised, more would be allocated by the Government.

Joji George, Managing Director, UBM India said, “Against the backdrop of India constantly seeking to match

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and surpass Western quality standards while maintaining lower manufacturing costs, at UBM, our objective for CPhI 2014 is to help elevate India as the global pharma destination by showcasing the unique positioning of the Indian pharma market and provide an optimum investment platform amidst its global counterparts.”

The event also saw the launch of a report titled, Pharma Insights: India 2015.

One of the most startling

trends to emerge from the report is that small and medium sized enterprises (SMEs) that have traditionally relied on the domestic market are now rapidly expanding and emerging as MNCs based on exports led growth strategies. For example, Galpha Laboratories, 66 per cent of sales this year were domestic, has seen exports expand by 400 per cent in the last year. Moreover, some of India’s biggest companies are also investing heavily in

R&D programmes to safeguard against slower growth as a result of the patent cliff, this has increasingly been across new drug delivery systems, formulation and manufacturing technology, along with biosimilars.

Report highlights CPhI India report forecasts new MNCs to emerge from India’s pharma SMEs and Japan and Africa as key export growth markets Indian manufacturers are

evolving up the value chain, concentrating on high-value, low volume work and shifting some R&D programmes to Western economies.

India’s biggest companies will see growth in CRAMS services for patented products as trust in regulatory and quality standards increases India to increasingly become a hotbed of clinical trial supply and advanced development work Biggest players to grow technology base through overseas acquisitions and partnering with big pharma for R&D Expenditures on R&D by 30 of the top pharma companies in India rose by 19.7 per cent, with investments focused on novel drug delivery systems Some of India’s biggest players are actively investing in R&D facilities abroad — Sun, Piramal, Lupin and Cipla New chemical entities from India to emerge in the next few years. Cutting edge research is underway, including innovations in creating an oral dosage form of insulin Huge future growth potential in Japan where Indian companies currently have limited presence, but there is predicted to be a rapidly rising use of generics In 2015 a significant number Indian companies will enter the African market as growth is predicted at 25 per cent to 30 per cent by volume per year Biologics and biosimilars to represent 15 per cent of Indian market value by 2020 India’s API producers have increasingly started to shift towards high value low volume work with complex chemistry and IP challenges.

Sudarshan Jain, Managing Director, Abbott Healthcare Solutions commented, “The Indian pharma sector is clearly growing, making significant contributions to the Indian economy and putting us on the global map. This sector is

MARKET redefining itself by moving to ‘next practices’ from ‘best practices’. We see strong thrust in the manufacturing arena in line with our national priority of ‘Make in India’.

Some of the entries for the award clearly reflect good work done by Indian pharma industry and augurs well for the industry.”

Devinder Pal, President, Catalyst Pharma Consult said, “One of the key challenges faced by the industry is to reclaim the enviable reputation it had earned, which has

unfortunately got tarnished rather badly. Happily, the FDA administered jolts have done the trick, it has awakened the industry to the need of building quality culture and shunning complacency and jugaad.”

Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting highlighted, “In CPhI/P- MEC , the key elements have always been innovation and excellence.

Organisations are increasingly focusing on 3 Ps – People, Planet and Profit and have started recruiting chief sustainability

The event also saw the launch of a report titled, Pharma Insights: India 2015

officers to give them competitive edge. The CPhI/P-MEC event will provide good insight in to initiatives in this area.”

Technical sessions were organised on topics like advances in fluid bed processing and tablet coating technologies, quality by design, the UK generics market, Active Pharmaceutical Ingredient (API) and finished pharma product preparation, e Lab notebook and e MES- Future of pharma industry, innovation drives green growth: advanced flow reactor technology industrial

production made real, improving quality and saving cost by lean materials handling and defining the future of digital advertising.

Another area that will transform over the coming years is biotech and biosimilars. The CPhI Pharma Insights: India report envisages further investment and expansion across this sector, predicting that by 2020, this part of the market will have risen up to around 15 per cent of total sales.

EP News Bureau – Mumbai

QUOTE UNQUOTE Chakravarthi AVPS

Suresh Pareek

Laxmikant Khaitan

Chairman Indian Institute of Packaging and CEO and Managing Director Ecobliss his time we have witnessed that the CPhI India has become a larger show in comparison to its previous editions. This might be because of the 'Make in India' campaign. After the launch of the campaign, we feel that the confidence level in the global market has increased. Many global pharma giants are coming up to make India a global hub for sourcing requirements. We conducted several meetings during the show with global as well as local clients. The only thing which I would like to point out to the organisers' of the show is that they should think about changing the venue location because the issues related to the infrastructure is getting severe year after year.

Managing Director, Ideal Cures e realised that this year’s CPhI and P-Mech show had the maximum number of foreign visitors, particularly at our stallnearly one-third of the visitors were foreigners. We haven’t seen these many international visitors in the previous years. I think 'Make in India' campaign has caused the success of the show as the campaign has spread a message of good governance. People have started believing in the Indian companies and their capabilities.

Business Manager- Healthcare Packaging India verall, this year’s event was good and saw a large number of customers from across the globe.

However, I felt that the attendance from Middle East, Bangladesh and Nepal were less.

T

Pradeep M Tamhane Managing Director, Wincoat Colours and Coatings his years' event was excellent and there was no doubt about getting good responses from domestic as well as from the international markets.

This year we did good business with new customers. This platform creates a better opportunity to meet our old customers as well as create an avenue to meet prospective customers. I feel organisers should work on the infrastructure part.

T

W

O

KVA Naidu Cyklop Packaging his time during the show we have received good responses, better than all the previous years. Also this year we managed to crack a business deal during the show.

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Christophe Boulanger Managing Director, NNE Pharmaplan PhI and P-Mec are shows where we have been participating for many years now.

However, I am not sure whether this kind of show is really meant for us or not. I suggest to the organisers to arrange a separate platform for us to understand the new technologies and better interactions options. For us this is more about the relationship building than anything else. We would like to know what plans do the organisers have for people like us. Separate sections like they have made it for bulk drugs and machineries? Also I believe they should have separate set of seminars and workshops here and engage people better. In fact I feel that the Interphex is a balanced show and there are all these opportunities.

C

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Ravi Sharma Chief Executive Officer, Allpharm Technologies personally feel the response to the exhibition was excellent. For us this time it resulted in big business. Also, we noticed that this year the maximum number of visitors were decision takers. We saw mixed representations from across the world.

I

this time which we had launched almost three years back in China and received good response for it.

Madan Mohan Singh Director, Snowbell Machines hrough associations, this year there were good turnout of buyers and customers for the show.

We have seen large number of visitors from countries like Syria, Egypt and Jordan.

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Ajit Singh Chairman, ACG Worldwide PhI and P-Mec India edition is getting better year after year.

Eight years back we had told the UBM to come to India and it will become a biggest show in the world and eventually did this happen.

However, they should work on infrastructure as it is hardly worth it. Our recommendation to the Ministry of Commerce is to make a event venue to have a large venue to accommodate events like this.

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Ken Fallu Li Wei Sales Manager, Truking Technology During the first two day, we saw many visitors at our stall and received good responses. I noticed that nearly 80 per cent customers were from India and remaining were from Nepal, Bangladesh, Korea, Pakistan, Egypt, Iran and Turkey as well as from South East Asia. We launched one of our product here

Marketing and Product – Managing Director, Optel PhI and P-Mec 2014 was a good show for us. This is a great platform for us to interact with our existing as well as prospective clients. Also, we have noticed that this year the footfall was good and received a good amount of business queries.

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EP News Bureau-Mumbai

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MARKET

UBM India,Express Pharma organise panel discussion The panel discussed impediments and opportunities facing Indian pharma as it transitioned from a volumes to value play IN A bid to deliberate upon the opportunities available for the India pharma sector in the global arena, UBM India, and Express Pharma organised a panel discussion titled, ‘From Volumes to Value Play: Towards Achieving Vision 2020.’ The panel discussion was a part of UBM India’s second edition of its annual India Pharma Awards and was recently held at The Westin Hotel, Mumbai. The panel discussion was organised with an aim to provide new insights to the strategy tool kit of pharma industry professionals.

The panelists were Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting; DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) and Ramesh Swaminathan. Chief Financial Officer, Lupin Pharma. The discussion was moderated by Viveka Roychowdhury, Editor, Express Pharma, Financial ExpressB2B. During the discussion, panelists spoke on factors holding back the Indian pharma industry and provided their recommended strategies for success.

In the course of the discus-

Issues related to compulsory licensing policies and challenges faced by domestic players were discussed

BentonSansCond Light The event aimed at looking at different approaches to diabetes management and explore options for patient care SINGAPORE RECENTLY, hosted ‘The 10 th International Diabetes Federation - Western th Pacific Region Congress and 6 Asian Association for the Study of Diabetes Scientific Meeting’. A symposium, ‘Directions in Diabetes - Explor-

ing Options for Patient Care’ was also a part of the event which aimed at discovering different approaches to diabetes management and explore options for patient care across regions.

Renowned pharma firms,

Boehringer Ingelheim and Eli Lilly and Company, conducted a media briefing on ‘Directions in Diabetes- Exploring Options for Patient Care,’ where various issues related to Type II diabetes (T2D) were discussed by expert doctors.

Dr Jisoo Lee of Boehringer Ingelheim talked about investigating early treatment conversations in T2D. Lee also spoke about IntroDia, which is the largest multinational survey of its kind to date investigating early conversations between physicians and people with T2D. Dr Kevin Tan spoke about DDP-4 inhibition: An effective management approach in T2D. Tan narrated the highlights of the data presented at Asian Association for the Study of Diabetes (AASD). The topic of discussion for Dr Chung Horn Lee was SGLT2 inhibition: An important treatment option in T2D management.

EP News Bureau – Mumbai

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sion, Dangi pointed out that the only way to progress is through innovation. The Indian pharma industry has to concentrate on innovation rather than imitation. Shah on the other hand revealed that the industry has no sustainable competitive advantage and so there is a need to look for innovative strategies. He also said that there is a need to make medicines available, accessible and affordable and that the government along with the industry needs to take a holistic approach towards attaining these goals.

Swaminathan spoke on drug pricing policies and highlighted the role of private players and government working in tandem to make medicine more affordable.

Issues related to compulsory licensing policies and challenges faced by domestic players were also discussed.

The discussion ended with Roychowdhury emphasising the ways and means needed to transform the Indian pharma sector from a volume driven industry to a value focused one.

EP News Bureau – Mumbai

Skytech conducts pharma event on QbD

SKYTECH RECENTLY conducted an event in Mumbai on the topic ‘How are the regulations and QbD influencing TOC, thermal validation & process optimisation activities in pharma?’ The event was attended by professionals from QA, engineering, water systems manufacturer validation engineers from process development. Discussions were held on the way activities in pharmaceutical industries are taking place in lieu of current situations and FDA stand on quality in all the aspect of drug development and manufacturing.

Asif Gavandi, Account Manager from Amphenol

Advance Sensors presented the importance of thermal validation and measurement with respect to regulations and how the basic concept of calibration and validation in day to day life is often misinterpreted.

Ramesh Sahu, Product Manager, Skytech and D Malviya, General Manager, Skytech presented TOC and current challenges in market and QbD with the case studies from innovator company who enhanced the productivity and product quality by adopting the QbD concept respectively.

EP News Bureau – Mumbai

EVENT BRIEF JANUARY 2015 — MAY 2015 8

Asia Pharma Expo-2015

ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu International Conference Centre, Dhaka, Bangladesh Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo2015. The exhibiting companies from more than 26 countries across the world are expected to participate. The expo will be accommodating 400 booths to the exhibitors. Major OEM suppliers from Asia, Europe and the US are likely to participate.

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66th Indian Pharmaceutical Congress

Contact details: Tel: +91 7940008233/ 53 Mob: +91 8000481114 Email: ceo@GPEexpo.com Website: www.asiapharma.org

66TH INDIAN PHARMACEUTICAL CONGRESS Date: January 23-25, 2015 Venue: Venue Hitex Exhibition Centre, Hyderabad Summary: Indian Pharmaceutical Congress Association will organise the 66th Indian Pharmaceutical Congress. It will be hosted by All India Drugs Control Officers' Confederation (AIDCOC). The event will be

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hosted by All India Drugs Control Officers’ Confederation (AIDCOC).

Theme for this year’s congress is India-Pharmacy of the world: Role of Indian regulators and pharma industry Contact details: 66th IPC Secretariat 7-2-1813/5/A, Sipra Labs, Adj. to Post Office, Industrial Estate, Sanath nagar, Hyderabad – 500018

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Mumbai Exhibition Centre, Mumbai

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PHARMA Pro & Pack Expo 2015

Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services.

Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services, purchase officers, equipment suppliers and

distributors, quality assurance/ quality control, maintenance engineering, R&D professionals, manufacturing/ production engineering, regulatory officers, operations management, validation, packaging engineering, vendor development, pharmacists.

Contact details: Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

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cover )

A PR CEY ISSUE ‘Anyarbitrarypricing decisions are detrimental to the investment climate for market expansion’

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he National List of Essential Medicines (NLEM) 2011 covers 348 drugs in 27 therapeutic areas and was drawn up considering prevailing disease conditions and the healthcare needs of India. Importantly, it was designed for ‘satisfying the priority healthcare needs of a majority of the population’. The list serves as a reference for the prescription of cost-effective medicines, of appropriate dosage form and strength. This NLEM was prepared by a core committee supported by 87 experts of diverse disciplines from across the country.

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Stakeholders represented regulatory bodies, public health entities and leading medical and scientific institutions, including the All India Institute of Medical Sciences (AIIMS), the Department of Pharmaceuticals (DoP), the Ministry of Health & Family Welfare (MoHFW), WHO, etc. as well as the pharmaceutical industry.

The National Pharmaceutical Pricing Policy (NPPP) of 2012, drawn up after a series of consultative dialogues across stakeholders, and with the approval of the Cabinet, lays down three key principles of pricing (a) Essentiality of Drugs (b) Control of For-

mulation prices only and (c) Market-based pricing. The essentiality criterion is addressed by the NLEM, with price control on the dosage and strengths as listed.

The revision of the NLEM is being undertaken, right now, by a core committee of experts from the MoHFW. The committee is following a robust and inclusive process, reaching out to various stakeholders across the nation. Two, of the six, planned consultations have been completed in Mumbai and

( As part of the ongoing revision of the National List of Essential Medicines (NLEM) 2011, the National Pharma Pricing Authority (NPPA) has shared a recommendation from Mumbai's Tata Memorial Centre that three drugs need to be taken off NLEM 2011 while 12 other drugs relating to oncology need to be added to it.

TMC’s recommendation will impact many oncology drug manufacturers as the three drugs recommended for price decontrol have restricted use or are no longer used, whereas the 12 drugs in the latter list are used in different types of cancer (like breast cancer, non-Hodgkins lymphoma (NHL), etc). With the increasing incidence of cancer, as well as the long term use of such drugs, the costs to patients are heavy.

This is but the latest in a series of moves by India's pricing authority designed to increase

THE MAIN FOCUS

public awareness about prices as well as check over-pricing by manufacturers. For instance, on November 18, NPPA had asked industry stakeholders to comment on a draft proposal to require the display of a distinguishing mark and ceiling price/ unit (it suggested a bold red strip with the words “DPCO Scheduled Drug” printed on it in black ink) on Scheduled Drugs under DPCO 2013.

While the NLEM revision process is still underway, Express Pharma takes stock of industry's position on this issue. While the issue seems to have united both the MNC as well as Indian pharma companies, there is no doubt that both sides – the pharma industry in the country as well as the regulator – will need to find common ground keeping the larger long term interests of both patients as well as industry in mind.

BY USHA SHARMA

Ranjana Smetacek Hyderabad respectively, while others are scheduled in Kolkata, Guwahati and so on. It is as part of this process that representatives from the Tata Memorial Hospital may have proffered their comments, along with other stakeholders.

It is important to recognise that revision of the NLEM is still underway and it would be premature to surmise or speculate about any suggested inclusions, before the process is complete!

The mandate of the

National Pharma Pricing Authority (NPPA) is to implement the provisions of the Drugs Prices Control Order (DPCO) within the ambit of the powers delegated to it.

While the price control of drugs is a legally mandated exercise under the Essential Commodities Act, the indiscriminate expansion of price controls will negatively impact the pharmaceutical sector, particularly research in newer and safer medicines. The industry seeks stability and

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DIRECTOR GENERAL, ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA

predictability in the regulatory environment and our expectation has been reinforced by assurances from the departments and officials in the Ministry of Chemicals and Fertilizers. The ministry committed to a consultative process with all stakeholders and transparent, marketbased pricing caps on essential medicines, with continued flexibility in the pricing of other medicines. We have been assured that government would work in close consulta-

tion with industry and that the intent was to build mutual trust and cooperation. Any arbitrary pricing decisions run contrary to these sentiments are detrimental to the investment climate for market expansion, brand building and employment generation in the future.

The pharma industry is an integral part of the healthcare system and its growth and sustainability is critical to a robust healthcare environment. Ultimately, a healthy industry is necessary for a healthy nation.

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cover ) ‘The recent activities of NPPAclearlysuggest that it means biz’

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n August 29, 1997 through a resolution of the Ministry of Chemicals and Fertilizers, an independent body of experts was established called the National Pharmaceutical Pricing Authority (NPPA). One of the primary objectives of the NPPA was to fix / revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in India. The NPPA’s mandate extended to monitoring the prices of decontrolled drugs in order to keep them at reasonable levels.

It is estimated that by the year 2020, the Indian pharmaceutical sector would grow to $ 55 billion, with the potential to reach $70 billion in an aggressive growth scenario. In view of such massive potential growth, the NPPA has relevance, more than ever before, to ensure that

this growth does not prejudice the general populace of the country.

Recently, much to the dislike of many, the NPPA has been flexing its muscles. The NPPA has issued price control orders for various drugs, the latest being the price control of ‘Dettol’.

These price control orders have made the industry come at loggerheads with the NPPA, the decision to control the prices of certain diabetic and cardiovascular drugs in July 2014 has already been challenged before various high courts.

Cancer has seen a steep rise in India and it is estimated that the number of cancer deaths in India will increase to seven lakhs by 2015. In such a situation, oncology drugs have become more important than ever before. Recently, the NPPA invited comments on the recommendations of Tata Memorial

Arijeet Mukherjee

ASSOCIATE,KHAITAN & CO

Centre for the deletion of three oncology drugs, and addition of 12 oncology drugs to the National List of Essential Medicines (NLEM).

The prime consideration for the proposed inclusion of the 12 drugs is their high cost, making them unaffordable for many.

Further, for many of these drugs

there is a substantial price difference between innovator brands and generic brands, suggesting ample scope for price control. From an industry perspective, sales of these drugs yield substantial profits and controlling their price would, in all probability, be resisted fiercely.

One of the key factors that makes a regulatory body stay relevant is flexibility and ability to adapt. The NLEM is not written in stone and must be updated by including those drugs which are needed the most and removing those which have restricted or uncommon use. It would be interesting to see whether NPPA will go ahead with updating the NLEM or will the pharma industry and NPPA lock horns yet again.

The NPPA has also recently invited comments on the proposal that all controlled drugs

should bear a distinguishing mark which will state that the drug is a ‘DPCO Scheduled Drug’ and also state the ceiling / retail price. This is NPPA’s yet another effort to raise consumer awareness, reduce overcharging cases and enhance accountability and self-regulation among the pharma industry and trade.

On November 27, 2014, the NPPA has issued a notice on issues regarding fixation of retail price for a ‘new drug.’

The recent activities of NPPA clearly suggest that it means business. The industry reaction may, however, be unwelcoming of this pro-activeness. However, perhaps the middle path can only be found when NPPA plays the balancing act between its objects and the growth aspirations of the booming Indian pharma industry.

‘Frequent tinkering with prices will breakpharma industry’s back’

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ver the past couple of decades successive governments have reduced the span of price control on pharmaceuticals in a phased manner reducing it to only 75 drugs. This pragmatic policy resulted in robust growth of the Indian pharma industry earning it the distinction of being recognised as ‘Pharmacy of the World.’

However, in DPCO 2013, the government took a U turn and brought 348 drugs of the NLEM under price control citing the Supreme Court’s order. A moronic formula of simple average prices of drugs with one per cent or more market share as ceiling price was adopted for this new order. Before the industry could digest this blow, the market was disrupted because of anti-competitive practices of AIOCD over trade margins reducing 2013 growth of

20 EXPRESS PHARMA December 16-31, 2014

the industry to single digit.

When the industry was gradually coming to normalcy, NPPA slapped one more blow by bringing 108 more drugs which are not in NLEM, under price control, justifying that these drugs are routinely used for controlling diseases like diabetes and CVD which have high prevalence in the country. This order was later withdrawn due to high court’s intervention. As if this was not enough, NPPA is now mulling over controlling prices of over a dozen anticancer drugs whose prices according to the Tata Memorial Centre for cancer are beyond the reach of common man. This frequent tinkering with the medicine prices will break the back of pharma industry and the industry is beginning to shy away from further investment.

In an intensely competitive business with over 10,000 man-

Dr Ajit Dangi

PRESIDENTAND CEO, DANSSEN CONSULTING

ufacturers churning out more than 70,000 generic brands, such needless intervention from the NPPA is uncalled for.

As such prices of medicines in India are one of the lowest in the world. Not only they are lower than those in the BRICS

countries but also lower than the neighbouring countries like Pakistan, Bangladesh, Sri Lanka etc.

While medicines constitute less than 25 per cent of the total healthcare costs and diagnostic tests, doctors’ consultation, hospital charges, post operative care etc. constituting the rest, focusing on medicine prices alone is superfluous when other costs are outside the purview of price control. The real solution lies in improving the access to medicines which is one of the lowest in the world at less than 40 per cent, by improving the health infrastructure and tightening the regulatory measures to improve the quality of medicines so that menace of counterfeit and substandard drugs is eliminated.

Preliminary investigation of deaths of over dozen young women recently in Chhattis-

garh whose sterilisation surgeries were botched up shows that one of the reasons for this tragic incident was contaminated drugs. This is an eye opener.

Also, expanding the span of health insurance as over 80 per cent population pays for medicines from its own pocket, requires urgent attention. The government gets away by spending just about one per cent of its GDP on healthcare but expects the industry to bear the brunt of medicine prices.

According to one PwC report, the Indian pharma industry has a potential to reach $70 billion in sales by 2020. With such regressive policies of DOP and NPPA, these ambitious goals are likely to remain as dreams. Perhaps the time has come to review the role of NPPA and question must be asked whether it should go the Planning Commission way.

( ‘We earnestlyrequest NPPAto withdrawthe draft proposal’

W

e appreciate that NPPA is making efforts to promote consumer awareness, which the Indian pharma Industry has been supporting all along. However, the manner in which this is being considered is not practical and implementable, as it raises many issues which would defeat the very purpose of our providing affordable efficacious medicines to the consumers.

The concerns that need to be addressed are as follows: 1. The Drugs and Cosmetics Rules under Rule 96 (xi) stipulates as follows: “[(xi) In addition to the other particulars which are required to be printed or written under these Rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than one mm in width and without disturbing the other conditions printed on the label under these rules, namely: — Narcotic analgestics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, anti-microbials, antiepileptics, anti-depressants, anti-coagulants, anti-cancer drugs and all other drugs falling under Schedules ‘G’, ‘H’, and ‘X’ whether covered or not in the above list.” Over and above what exists in the Drugs and Cosmetics Rules as above, proposal for a distinguishing mark (may be a bold red strip with the words ‘DPCO Scheduled Drug’ printed on it in black ink) would mean that the scheduled drugs will need to carry two red lines which would create more confusion among the consumers.

2. For all packs which are very small, it would not be possible to add any additional field or lines. The size of the packs of ampoules, strips etc are very small

S V Veerramani

PRESIDENT, INDIAN DRUG MANUFACTURERS' ASSOCIATION (IDMA)

and the requirements under the Drugs and Cosmetics Rules 96 and 97 regarding declarations to be made on each pack of drug is mandatory. And this distinguishing mark would not be able to fit in, in addition to all the declarations already required to be displayed on each such pack.

3. The draft proposal also mentions that the pack will carry the information on ceiling price per unit additionally along with the MRP already printed as per DPCO 2013 Rules. This would be totally confusing to the consumers as they are not aware of the state-wise VAT taxes (local taxes) added to the ceiling prices. This could also create illwill and chaos among the consumers, as they naturally would prefer to pay the lesser printed price, i.e. the ceiling price and not the MRP, which they need to pay.

4. Also, when the Supreme Court has ruled that no pack should be available at two different prices at the same time to avoid confusion among the consumers, how is it mandatory to print the ceiling price and MRP on the same pack and expect the consumer to understand the working of DPCO to calculate the MRP to be paid?

5. All the packs and labels of scheduled drugs will have to be changed and artworks

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redesigned and printed reprinting of labels/ cartons/ foils, etc. to incorporate the new suggestions, entailing additional costs running into hundreds of crores, which are not covered under DPCO 2013.

6. In addition to preparation of art work, which is a onetime cost, the cost of packing material will also go up.

7. Regarding invoking Legal Metrology Act 2009 and the Legal Metrology (Packaged Commodities) Rules 2011, Drugs are exempted from the provision of these Rules under Rule 26(c).

And this exemption stems from the very fact that there already exists under the Drugs and Cosmetics Act more than adequate labeling provisions so that the labeling provisions under the Packaged Commodities Rules would be redundant. If the exemption is removed, then all drugs available in the market will also have to additionally comply with these Rules and be governed by the size of fonts and principal display concepts etc. embodied in the legal metrology (packaged commodities) Rules for declarations.

8. A drug which falls under the scheduled category for one manufacturer as a ‘new drug’ may not necessarily be a scheduled drug for another manufacturer. This will have some drugs with red line and the same drugs without the red line and will only add to the confusion among the consumers and medical doctors.

In view of the facts and concerns mentioned above, it would be more pertinent to consider better and more practical methods of publicising the provisions of the DPCO, of fixing ceiling prices of formulations and publicising those prices of scheduled formulations as well as of nonscheduled formulations. We earnestly request NPPA to withdraw the draft proposal in the interest of the public, the manufacturers and the regulatory authorities.

THE MAIN FOCUS

‘Reducing prices of innovator drugs will not help’

T

he National List of Essential Medicines (NLEM) policy has been adopted to strike a balance between the growing pharmaceutical industry and the need to make reasonably priced medicines available to consumers, particularly the poor masses.

The Tata Memorial Centre recommendation of taking three drugs off the NLEM-2011 list is

innovator brand of Zoledronic Acid for one vial of 4 mg strength is ` 10,000, whereas its generic equivalent is available in the market for a mere ` 265 for one vial of 100 mg strength. So, it is not clear how reducing the prices of innovator drugs will help the general masses, especially when they already have access to equally good drugs at a fraction of the cost.

Secondly, some of the

One of the important aspects of bringing any drug under the NLEM is to fix ceiling prices for the benefit of the general public worth appreciating as these drugs have restricted use or are no longer used. So, taking them off the list would not make any difference to either the pharma industry or the general masses.

However, the suggestion to add 12 drugs catering to the oncology segment to the NLEM is a bit ambiguous if the sole idea is to bring price parity.

One of the important aspects of bringing any drug under the NLEM is to fix ceiling prices for the benefit of the general public. From that perspective, adding those drugs to the NLEM which already have cheaper and cost-effective substitutes available in the market does not serve the desired purpose. For instance, the cost of the

12 drugs suggested for inclusion in the NLEM do not have any comparator in the market. In this case, it is not clear as to how the weighted averages will be calculated to fix their prices in order to safeguard public interest.

However, if this notification gets through, it will have little impact on Venus Remedies as it manufactures only some of these 12 products, the prices of which are already very low as compared to the innovator drugs. Moreover, the products that Venus Remedies manufactures out of this list of 12 drugs largely cater to the overseas market, where the concept of MRP holds no relevance. u.sharma@expressindia.com

EXPRESS PHARMA

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December 16-31, 2014

MANAGEMENT INSIGHT

The ‘Counterfeit’conundrum in pharma industry – Is it time for concerted action?

DR GOPAKUMAR G NAIR, Chief Executive Officer, Gopakumar Nair Associates

The quality control measures at the customs with regard to the import and the export of medicines and APIs need to be strengthened to eliminate substandard, spurious, fraudulent and counterfeit medicines from international trade to or from India. An insight by Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates SSFFC — ‘the latest World Health Organisation (WHO) initiative on Substandard/Spurious/Falsely-labelled/ Falsified/ Counterfeit medical products’ has been making slow but steady progress through meetings in 2012, 2013 and the latest on October 29-31, 2014. A technically strong delegation comprising four seniormost drug regulators from (DCSO/DCGI) office represented India.

Countries like Brazil, Argentina, Ghana, Nigeria (NAFDAC-DG), the US, Europe and Korea were represented by strong delegations. However, not very surprisingly, China was represented only in token, by their officer in Geneva. India has been sending out ‘mixed signals’ to the global pharmaceutical community including WHO, primarily due to the genuine concerns expressed partially by the generic pharma industry and substantially by the civil society.

Consequent to the efforts of the MNCs and the western world countries to interpret ‘counterfeit’ as to include intellectual property violations and infringements also through International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of WHO and AntiCounterfeiting Trade Agreement (ACTA) having met with strong resistance, WHO has come up with SSFFC which has excluded the originally inclusive IP Issues such as patent infringement from the ambit of

22 EXPRESS PHARMA December 16-31, 2014

SSFFC. It is time for India to look at the core issues seriously and pursue permanent and futuristic solutions to the issues of quality, reliability, efficacy and good manufacturing practices.

A recent report by a US Organisation headed by Roger Bate had highlighted the lack of uniformity in quality of medicines supplied to Africa. The report had further emphasised on the substandard and spurious status purportedly of medicines from Indian origin. It is surprising that the American Enterprise Institute in Washington and their researchers could access unauthorised and unregistered medicines available in the African marketplace, while African and Indian healthcare regulatory authorities have failed to take a note. Stringent controls on pharma manufactures in India with regard to Good Manufacturing Practices (GMP) and quality excellence is

called for. India needs to ensure that no unregistered medicines get exported to any country in the world. While, India is claiming to be ‘Pharmacy of the World’, any spurious or counterfeit medicines labelled as of Indian Origin, could substantially damage India’s reputation for quality. In this context, upgradation and strengthening of infrastructure at Central Drugs Standard Control Organization (CDSCO) and Drug Controller General (India) (DCGI’s) office is of utmost priority.

Of late, there have been many instances of spurious, substandard and counterfeit medicines originating in China, but labelled as of Indian origin have been reported to have surfaced in African markets. These are clear instances of counterfeit medicines, the source and origin being different from what is on the label. These type of counterfeits where the prod-

uct label claims to be originating from a manufacturer, while the product has fraudulently been manufactured by a third party amounts to criminal practice and need to be detected and punished severely. The quality control measures at the customs with regard to the import and the export of medicines and APIs need to be strengthened to eliminate substandard, spurious, fraudulent and counterfeit medicines from international trade to or from India.

Tragedy struck a recent sterilisation camp in India where 15 women died after sterilisation, reportedly because of administration of contaminated and spurious antibiotic from a Raipur manufacturer. The said medicine has been found to be contaminated by zinc sulphide, a rat poison. The manufacturer appears to be a licensed manufacturer. Even though the drug

manufacturing licence has been cancelled, the punitive action should include prevention by ensuring that the concerned persons are no more permitted to set up any other drug manufacturing facility anywhere in the world.

A blacklist need to be created to exclude persons with criminal record from getting back into the pharma manufacturing and trade. The Indian Drug Regulations under Drugs and Cosmetics Act and Rules thereunder need to be reviewed, strengthened and harmonized both in letter and spirit. India should join International Code of Harmonisation (ICH) as an observer with a view to become a regular member in five to ten years. This can only be done by strengthening the office of the DCGI. In the emerging scenario, India needs to take confident strides towards quality assurance of global standards. The current apprehensions on interpretations of SSFFC medical products must be overcome by concrete propositions from India. The latest definition excludes patents and patent infringement disputes from the definition of counterfeit in countries and regions such as the US and the EU as well as ASEAN and RCEP. This negotiated compromise will lead to a better handling of quality issues across the board in pharma trade, globally.

REPORT

Recent cardiovascular clinical trials framing debate on personalised treatment: GlobalData

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It has been proposed that one should err on the side of short-term therapy for patients at high risk of bleeding

Ergonomic Design Which Reduces User Fatigue

DISCUSSIONS REGARDING latebreaking cardiovascular clinical trials among leading medical scientists are placing considerable emphasis on individualised patient care, particularly in the area of dual antiplatelet therapy, according to an analyst with research and consulting firm GlobalData.

At the recent 2014 American Heart Association (AHA) meeting in Chicago, the results of the Dual Antiplatelet Therapy (DAPT) Study played a central role in presentations and debates regarding the use of antiplatelet bloodthinning agents.

Eric J Dimise, analyst, GlobalData’s covering cardiovascular and metabolic disorders, states that the DAPT Study attempted to address a key outstanding question concerning how long physicians should apply dual antiplatelet therapy following implantation of a drug-eluting stent (DES), with leading investigators concluding that the solution may depend upon individual patient needs.

Dimise says, “The study revealed that treatment with dual antiplatelet therapy (aspirin and clopidogrel or prasugrel) decreased the risk of stent thrombosis and major cardiovascular and cerebrovascular events, compared to treatment with aspirin alone during the 12 to 30-month period following implantation of a DES. However, this was achieved at the price of an increased frequency of bleeding.

“As a consequence, the debate now focuses on how physicians should strike a balance between reducing cardiovascular events while simultaneously minimising bleeding risk.”

According to the analyst, it has been proposed that one should err on the

At the recent 2014 American Heart Association meeting in Chicago, the results of the Dual Antiplatelet Therapy Study played a central role in presentations and debates regarding the use of antiplatelet bloodthinning agents

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Quality Assurance side of short-term therapy for patients at high risk of bleeding, while therapy beyond 12 months should be considered for those at high risk of a recurrent ischemic event.

However, cases have been presented in favour of both short and long-term therapies, with the former leaning on the resultant diminution of bleeding events observed in the placebo group of the DAPT Study, and the latter arguing for the clear cardiovascular event-reduction benefit.

EP News Bureau-Mumbai

EXPRESS PHARMA

23

December 16-31, 2014

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RESEARCH I N T E R V I E W

‘The government could do more in terms of how it sees research activities’ The government is doing many positive things in the biosciences, but could do more, in terms of how it sees research activities, says this year’s winner of the Infosys Prize in the Life Sciences category, Dr Shubha Tole, Professor and Principal Investigator, Department of Biological Sciences, Tata Institute of Fundamental Research (TIFR), Mumbai. In an email interaction with Viveka Roychowdhury, she elaborates on two major hurdles faced by Indian researchers who wish to take their work to an international level. While appreciating the recent decision of the Union ministry to hike PhD stipends by up to 50 per cent, she says increases of this kind should come as a matter of course, linked to inflation Dr Tole, congratulations on winning this year’s Infosys Prize in the Life Sciences category. The Prize endeavours to ‘elevate the prestige of scientific research in India and inspire young Indians to choose a vocation in scientific research.’ Has the Government of India done enough towards this objective? What more can be done?

The government is doing many positive things in the biosciences. The Department of Biotechnology has many schemes and funding is available for good, welljustified and well thought through research projects. It could do more, in terms of how it sees research activities.

Indian researchers face two major hurdles in order to take their work to an international level and compete on a world forum.

Both are linked to ‘crossing international borders’: first, it is really time-consuming to import perishable, expensive reagents that biosciences research depends on.

Clearing frozen/perishable shipments is not something that’s automatically done on a priority basis. We have lost shipments because they thawed during transit. Yes,

24 EXPRESS PHARMA December 16-31, 2014

we get around the problem by employing efficient clearing agents, but a government policy that puts research materials in a priority clearance category would greatly help.

Secondly, I don’t think policy-makers appreciate the importance of scientists being able to engage with and interact with the international community.

Regular DBT/DST grants do not have even a budget head for foreign travel, but the prestigious fellowships like the Swarnajayanti fellowship do.

Yet, it is pretty clear that one can’t play on an international field if one can’t routinely go to meetings and discuss ones work, bring out what is going on in India, engage, collaborate, etc. Eventually, when one’s paper gets reviewed by someone sitting in another country one has much more difficulty if one hasn’t had the opportunity of getting the community’ comments beforehand in a meeting. Or, one needs a particular reagent or tool to complete a study, and the quickest way to do it would be to set up a collaboration, but it is all harder if you don’t meet potential collaborators face to face at

Students and post-docs need better compensation if they are to spend the better part of their 20’s acquiring research skills

annual meetings.

Oddly, it is considered to be a weakness if one collaborates with someone abroad, to the point that committees evaluating candidates for some prestigious awards pay particular attention to whether one has ‘foreign collaborators’- and discount or undervalue work resulting from such interactions, instead of seeing it in a positive light. If you collaborate with someone, it means they consider your interaction valuable.

Sometimes the intellectual ideas are yours, the collaborator has just provided some key reagents or tools. Sometimes, you are the one who provides a missing piece to a study someone else is working on.

All of this international interaction makes for healthy scientific growth, something our country needs to improve on.

What is your opinion on the recent decision of the Union ministry to hike PhD stipends by up to 50 per cent? Will this encourage researchers or will it divide them?

A long awaited and welcome move. Students and post-docs need better

compensation if they are to spend the better part of their 20’s acquiring research skills, so that they can go on to contribute to scientific advances when they finish their training. The work is rewarding in itself, but needs to be compensated in a manner that encourages, attracts and sustains young people who want to be in research. It is difficult for example, to support a family on a postdoc salary even after the enhancement. Why put our highly trained personnel through such a constraint?

Furthermore, increases of this kind should come as a matter of course, linked to inflation. Each government employee gets a ‘dearness allowance’ each year, why shouldn’t students and postdocs? It is not reasonable to wait till things reach a low point and then increase things in a big jump.

Rather, the government should recognise this (student and post doctoral trainee) workforce as one that is valued, in whose hands the future progress of the country lies, and one that needs to be compensated properly in a manner that is inflation-protected. viveka.r@expressindia.com

CLINICAL UPDATES

AstraZeneca and Lilly move Alzheimer’s drug into big trial ASTRAZENECA and Eli Lilly have started a large trial of their experimental Alzheimer's drug, seen as a promising, but still risky, approach for slowing the memory-robbing disease. The pivotal Phase II/III clinical trial will involve more than 1,500 patients with early Alzheimer’s, the first one of which has now been enrolled.

The study is expected to complete in May 2019, according to

the clinicaltrials.gov website.

AstraZeneca, which initially developed the drug, signed a partnership deal with Lilly in September for the product, known as AZD3293 or LY3314814. The medicine works by blocking an enzyme called beta secretase that is involved in production of betaamyloid, a protein that creates brain plaques. Such medicines are known as BACE inhibitors.

Merck & Co is currently

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viewed as being in the lead in the BACE inhibitor field, having announced plans for a Phase III trial a year ago.

Oral drugs to block beta secretase have taken centerstage after an injectable class of medicines, meant to remove plaque once it has already formed, disappointed in trials conducted by Pfizer and Eli Lilly in 2012.

Reuters

EXPRESS PHARMA

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December 16-31, 2014

RESEARCH

France, Germany suspend some drug approvals over Indian data The German watchdog said it was investigating 176 approvals given to 28 drugmakers REGULATORS IN France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by India's GVK Biosciences, French watchdog ANSM said. The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the US citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.

“This decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs,” ANSM said. All of the drugs being suspended, several of which are made by Mylan and Abbott, have brand name equivalents that can be used instead, so patients will not have to interrupt

their treatment, it added.

ANSM and Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said they were investigating the drug approvals based on clinical trials meant to show that these generic drugs were equivalent to the original branded versions conducted by GVK Bio between 2008 and 2014.

ANSM said it had alerted European authorities after it inspected GVK Bio’s site in Hyderabad, India, and found ‘anomalies’ in the way electrocardiograms (ECG) were monitored during the bioequivalence studies. It said the inspection raised serious concerns over whether the company's studies complied with good clinical practices. GVK Bio's CEO Manni Kantipudi disputed the French watchdog's findings and said ECGs were not an important component of the drug efficacy.

ANSM concluded GVK Bio, which conducts clinical research for domestic and foreign drugmakers, manipulated the ECGs without taking into account the company's views, he said. “We have agreed to redo the studies, I'm fine with that, but don't say that there was gross manipulation of the ECGs,” Kantipudi told. He said the company had received board approval to spend $5.7-$6.5 million for new studies.

The European Medicines

Agency (EMA) separately released a statement saying it would “issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU.” That recommendation is expected in January 2015. The German watchdog said it was investigating 176 approvals given to 28 drugmakers.

It did not name the drugs or companies affected.

BfArM said it was ordering

drugmakers whose approvals were found to have been based on data from GVK trials to stop distributing the concerned drugs until they could provide data from new studies.

ANSM said several drugmakers - it did not identify them had already offered to carry out new studies which, if positive, could allow the drugs on the market again. GVK Bio’s Kantipudi said the company has started conducting new studies for five to six of its clients. About 35 of the company’s 400 clients have been affected by the European regulator’s move, he said.

He said the US Food and Drug Administration inspected its Hyderabad plant in June, after the French regulator’s audit, and was satisfied with the ECG-related data. No other regulator had contacted the company since then, he added.

Reuters

RESEARCH UPDATES

FDApanel recommends approval for Actavis’antibiotic drug The drug, ceftazidime-avibactam, is safe and effective to treat intra-abdominal infections (cIAI) and urinary tract infections (cUTI) ACTAVIS SAID a panel advising the US Food and Drug Administration recommended the approval of its antibiotic to treat two infections caused by drug-resistant bacteria. The drug, ceftazidime-avibactam, is safe and effective to treat intraabdominal infections (cIAI) and urinary tract infections (cUTI), when limited or no alternative treatments are available, the

26 EXPRESS PHARMA December 16-31, 2014

anti-infective advisory committee said.

The panel, however, raised concerns around labelling, particularly for patients with renal impairment, Sanford Bernstein & Co analyst Aaron Gal wrote in a note.

The committee also voted not to recommend the drug’s use in treating hospital-acquired bacterial pneumonia

(HABP) and bacteremia, citing inadequate evidence.

Dublin, Ireland-based Actavis said it intends to continue testing the drug to generate more data. While the FDA is not obligated to accept the panel’s recommendations, it typically does so.

The company said it expects the regulator to give its final decision on the drug in the first

quarter of 2015. Bernstein’s Gal said he expects the drug to generate as much as $170 million in sales annually.

Ceftazidime-avibactam is being co-developed with British drugmaker AstraZeneca. Actavis holds the rights to market it in North America, while AstraZeneca has rights for the rest of the world.

Reuters

RESEARCH

Scientists find brain mechanism behind glucose greed

In people it may play a role in driving the preference for sweet and starchy foods BRITISH SCIENTISTS have found a brain mechanism they think may drive our desire for glucose-rich food and say the discovery could one day lead to better treatments for obesity.

In experiments using rats, researchers at Imperial College London found a mechanism that appears to sense how much glucose is reaching the brain and prompts animals to seek more if it detects a shortfall. In people, the scientists said, it may play a role in driving our preference for sweet and starchy foods.

Glucose, a component of carbohydrates, is the main energy source used by brain cells.

“Our brains rely heavily on glucose for energy, but in our evolutionary past it would have been hard to come by. So we have a deep-rooted preference for glucose-rich foods and seek them out,” said James Gardiner, who led the study and published its findings in the Journal of Clinical Investigation.

Gardiner’s team started with a hypothesis that an enzyme called glucokinase, involved in sensing glucose in the liver and pancreas, might play a role in driving glucose desire.

Glucokinase is found in part of the brain called the hypothalamus,

which regulates various functions including food intake.

In their experiments they first found that when rats go 24 hours without eating, glucokinase activity in an appetite-regulating centre in the hypothalamus increases sharply.

The rats were given access to a glucose solution as well as their normal food pellets, called chow. When the researchers increased the activity of glucokinase in the hypothalamus using a virus, rats consumed more glucose in preference to chow. When glucokinase activity was reduced, they consumed less glucose.

Gardiner suggested that in people it might be possible to reduce glucose cravings by changing the diet, and said a drug that could act on this system may potentially prevent obesity.

“People are likely to have different levels of this enzyme, so different things will work for different people,” he said in a statement about the study. “For some people, eating more starchy foods at the start of a meal might be a way to feel full more quickly by targeting this system, meaning they eat less overall.”

Reuters

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RESEARCH

Addition of Amgen drug boosts benefits in relapsed myeloma Patients with the blood cancer who received the Kyprolis regimen for 18 months also had a longer duration of response SIGNIFICANTLY MORE patients with relapsed multiple myeloma responded to a three-drug regimen including Amgen’s Kyprolis than those who got the standard twodrug treatment, according to results from a late-stage trial.

Patients with the blood cancer who received the Kyprolis regimen for 18 months also had a longer duration of response and reported better health-related quality of life, data presented showed.

Overall survival data was not yet available, but researchers reported a trend toward improved survival seen with the three-drug regimen.

The Phase III Aspire trial tested Kyprolis in combination with Celgene’s Revlimid and the chemotherapy drug dexamethasone versus the two drugs without Kyprolis in 792 patients whose disease relapsed after prior treatments.

Amgen previously reported the Kyprolis regimen achieved the primary goal of the study by significantly increasing the time before the disease began to worsen. Details and results of secondary goals were being presented at the American Society of Hematology meeting in San Francisco.

The data should help increase use of Kyprolis, the drug at the centre of Amgen's nearly $10 billion purchase of Onyx Pharmaceuticals. Kyprolis had $94 million in third quarter sales. “This is really

an important study that’s going to set the stage for improved therapy for patients worldwide,” said Dr Keith Stewart, the study’s lead investigator from Mayo Clinic in Arizona. “It probably establishes this (regimen) as the standard of care.”

The overall response rate was 87 per cent for the three drugs versus 67 per cent for the current standard of care.

Three times as many patients had a complete response to the Kyprolis regimen, meaning no detectable sign of cancer —

32 per cent versus 9 per cent.

The median duration of response was 28.6 months for the Kyprolis group compared with 21.2 months for the control arm. Stewart said researchers now believe the results could have been even better had patients stayed on the Kyprolis regimen for longer than 18 months.

About 114,000 new case of multiple myeloma, the second most common blood cancer are diagnosed annually worldwide, according to the International Agency for Research on Cancer. The rate of adverse side effects and discontinuations due to side effects were nearly identical in the two groups, providing evidence that adding Kyprolis did not cause additional toxicities. “It was reassuring with respect to the tolerability of the threedrug cocktail,” Stewart said.

Reuters

FDApanel says newer HIVtests effective NEWER METHODS to test donated blood samples for HIV infections are effective, a panel of experts at the US Food and Drug Administration concluded, in a move that could limit the ban on donations by men who have had sex with other men (MSM).

The FDA’s ban, in place for about three decades, disallows donations from men who have had sex with even one man since 1977, as they are recognised to be at a higher risk of acquiring HIV. While the FDA’s Blood Products Advisory Committee discussed the new methods to test samples donated by MSMs for HIV, it did not make a recommendation on limiting the ban. An advisory committee to the Department of Health and Human Services earlier in November had recommended replacing the ban with a new one that bars donations from men who had sex with another man in the past year.

Reuters

Merck drug shows promise against lymphoma Keytruda this year was approved to treat advanced melanoma, the deadliest form of skin cancer MERCK & Co’s drug that harnesses the immune system to fight cancer showed promise in Hodgkin lymphoma patients whose disease had progressed following prior therapies, according to data from a small, early stage trial being presented at a medical meeting. In the ongoing study of 29 patients, 66 per cent had a meaningful response to the drug, Keytruda, after 24 weeks of treatment, including six patients (21 per cent) who achieved complete remission.

Six other patients in the Keynote-013 study unveiled had stable disease at the time data was analysed, while the lymphoma progressed in four pa-

28 EXPRESS PHARMA December 16-31, 2014

tients. “The drug is outstanding,” said Dr Craig Moskowitz, the study’s principal investigator from Memorial Sloan Kettering Cancer Center in New York.

“It may be a small patient population, but it is really remarkable,” he said. “And it’s really well tolerated.” There are about 9,000 new cases of Hodgkin lymphoma in the US in 2014, according to the Leukemia and Lymphoma Society. About a quarter are likely to relapse after initially successful treatment, highlighting the need for new options.

Keytruda (pembrolizumab) belongs to a new class of drugs called PD-1 inhibitors that have

There are about 9,000 new cases of Hodgkin lymphoma in the US in 2014, according to the Leukemia and Lymphoma Society

generated great enthusiasm in the medical community. They work by blocking a mechanism tumours use to camouflage themselves from the immune system, allowing it to recognise and attack the cancer.

Patients in the study had either had a stem cell transplant or were ineligible for one, and all had been previously treated with the Seattle Genetics drug Adcetris. The average time to response with Keytruda was 12 weeks, according to data being presented at the American Society of Haematology meeting in San Francisco. The median duration of response had not yet been reached. Patients will stay

on the drug until their cancer progresses. Keytruda this year was approved to treat advanced melanoma, the deadliest form of skin cancer, making it the first drug from the PD-1 class to reach the US market. Bristol-Myers Squibb Co is developing a rival medicine. This marks the first Keytruda data reported against a type of blood cancer. It is also being tested in lung, breast, bladder, gastric, and head and neck cancers. The most common side effect was shortness of breath, Moskowitz said. One patient discontinued treatment due to pneumonitis, an inflammation of the lung tissue.

Reuters

PHARMA ALLY VENDOR NEWS

NMR spectrometer boosts Wacker’s local expertise at R&D facility in Kolkata NMR spectroscopy is used to obtain physical, chemical and structural information about molecule WACKER, THE Munich-based chemical company, is enhancing its scientific expertise in India by equipping its R&D facility in Kolkata with a novel high-tech Nuclear Magnetic Resonance (NMR) spectrometer. The 400 MHz Nanobay NMR was officially put into operation recently.

NMR spectroscopy is one of the principal techniques used to obtain physical, chemical and structural information about a molecule. Wacker is one of the few manufacturing companies in India that operates such an inhouse NMR at its R&D facility.

“Our industry demands testing and evaluation of novel compounds in a wide range of chemical space to feed its pipelines,” said Soumitra Mukherjee, Managing Director, Wacker Metroark Chemicals, during the launch ceremony.

“The installation of the

NMR will help leverage our R&D centre capabilities and will multiply our possibilities to create new innovations. With this, we are able to fulfill our customers’ needs in the growing regions of India and Asia and also cater to our key global customers,” Mukherjee added.

A NMR spectrometer is an analytical research instrument which provides detailed information about the structure, dynamics, reaction state and chemical environment of molecules. In organic chemistry, it is the ultimate analytical capability. Wacker will use this equipment for the structural analysis of silicones, silanes and allied substances and for detailed information on the exact three-dimensional structure of chemical molecules in a solution.

Putting NMR tube in sample changer

EP News Bureau-Mumbai

Quintiles launches solution for Marketed Product Maintenance The solution will help biopharma companies better manage all activities required to maintain the licenses for their portfolio of marketed products QUINTILES ANNOUNCED a new offering that combines its industry-leading pharmacovigilance, regulatory dossier/label maintenance, benefit-risk management and analytic expertise into one integrated solution.

This solution will help biopharmaceutical companies better manage all activities required to maintain the licenses for their portfolio of marketed products.

Underpinned by a fully-integrated technology platform, the new offering, called Marketed Product Maintenance (MPM),

will provide biopharma companies with greater data-driven insights on the benefit-risk profiles of their products. These enhanced insights will enable customers to identify potential product risks, fulfill increasingly complicated regulatory requirements and help them make better decisions about their marketed products. By using technology and subject matter expertise to connect the post-approval requirements and license maintenance processes more effectively and efficiently, bio-

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pharma companies can generate greater return on investment from their portfolio of established products by redeploying resources on prioritised, growth-oriented products.

Paula Brown Stafford, President of Clinical Development, Quintiles said, “Within most biopharma companies, regulatory, safety maintenance and benefit-risk management functions could benefit from more interdependence. Meanwhile, these companies are facing more complex safety and regu-

latory requirements, along with increasing budget constraints, making it increasingly difficult to achieve their regulatory obligations while improving the total cost of managing their established products. Integrating these functions through our innovative MPM solution will assist customers in maximising the commercial value of their established products.”

These services will be delivered globally as an integrated and efficient turnkey solution,

leveraging Quintiles’ extensive safety, regulatory, benefit-risk management research experience, as evidenced by: ◗ 99 per cent on-time compliance for approximately 1.5 million clinical, post-marketing, and device safety reports processed globally since 2009; ◗ 100 per cent of approximately 1,500 electronic common technical documents (eCTDs) submitted to the EU, US and Canada passed technical validation.

EP News Bureau-Mumbai

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December 16-31, 2014

PHARMA ALLY

Danish ambassador visits Ferring facility in Maharashtra The manufacturing site, expected to be inaugurated next year, is being built as per the latest European standards THE DANISH Ambassador to India, HE Freddy Svane visited the state-of-the-art manufacturing plant being constructed

by Ferring Pharmaceuticals in the MIDC area of Ambernath in Thane district of Maharashtra.

The manufacturing site, which is expected to be inaugurated next year, is being built as per the latest European standards in order to cater to the global supply of Ferring’s major product PENTASA (mesalazine) a drug used to treat and control the symptoms of inflammatory bowel disease.

Ferring Pharmaceuticals has already established its R&D facility in the area for new drug delivery platforms used for production of Minirin (desmopressin), their market leading urology product. This facility has been operational since 2007.

The ambassador, recognised the Ferring site as a clear example of successful interna-

tional businesses flourishing in India and expressed high hopes from the facility at a time when the new Maharashtra government has assured support to back export-oriented industry.

“The whole idea of the site fits very well with Prime Minister NarendraModi’s vision to back indigenous production.

This not only creates huge job opportunities and fund inflow for the nation, but also paves the way for similar foreign companies looking to invest offshore as Ferring successfully brings its technologies and expertise to ‘Make in India,” the ambassador conveyed.

The manufacturing site is being built to include the most efficient in-house processes within Ferring’s globally maintained standards as well as environmental norms such as zero emissions in the region.

“Our philosophy at Ferring is ‘People Come First’. We focus our efforts to provide utmost

Freddy Svane, Danish Ambassador being welcomed by Ferring Therapeutics Chairman and Managing Director Dr Ashok Alate

benefits to our employees, customers and society at large.

While we take extra caution for employee safety at the plant, we aim to use minimum organic solvents in the production process. The plant itself is built with the aim to support the use of effluent treatment plant in the industrial area,” stated Dr Ashok Alate, Chairman and MD, Ferring Therapeutics.

Ferring’s operations in India started in 1996 and current activities include import, export, local manufacturing, sales and marketing, R&D, etc; employing approximately 300 people.

In 2013, Ferring started building the drug manufacturing facility with an estimated investment of `200 crore that will effectively complement its requirements worldwide. The project is aptly named Pentasa Expansion and Oral Pharmaceuticals for Local Economy (PEOPLE).

EP News Bureau-Mumbai

HRS Process Systems participates at P-MEC India The company displayed specialised, high performance heat transfer solutions HRS PROCESS Systems (HRS), part of HRS Group, UK participated in the 6th annual Pharma Machinery, Equipment & Technology (P-MEC) India expo recently held at Bombay Exhibition Centre, Mumbai. The company displayed specialised, high performance heat transfer solutions such as ECOFLUX corrugated tube heat exchangers, HRS Funke plate heat exchangers and HRS hot water systems.

One of the leading heat exchanger specialists catering to

30 EXPRESS PHARMA December 16-31, 2014

the pharma industry, HRS operates at the forefront of thermal processing technology.

The company is known for offering energy efficient and hygienic solutions for an extensive range of applications.

HRS’ clients such as Cipla, Cadila, Dr Reddy’s, Laurus, Mylan, Ranbaxy, Sun Pharma and many more reputed pharma companies visited this event.

"We believe the pharma industry has acknowledged HRS as a reliable technology partner for their various heat

transfer solution requirements and thorough process expertise. HRS not only provides quality heat exchangers but also solutions for their various heat transfer requirements.

This has enabled pharma companies maximise their return on investment by minimising costs through better energy management and thus leverage this huge growth potential of the pharma industry," said V Gokuldas, Managing Director, HRS Process Systems.

EP News Bureau-Mumbai

Q A &

PHARMA ALLY

WITH SCHOTT GLASS INDIA

PRODUCT

Phenomenex SecurityGuard Cartridge System protects all GPC columns

Q A

Q A

PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has announced the extension of its SecurityGuard family of products to include a cartridge-based system that protects any non-aqueous gel permeation chromatography (GPC) column. The cartridge system replaces traditional guard columns, offering a more convenient and cost-effective system for protecting expensive GPC columns from the damaging effects of contami-

nants and microparticulates.

The unique cartridge design enables the user to visually inspect the surface of the column’s packing material at any time and monitor contaminant build-up. The visual inspection allows for cartridge changes at the right time to maintain optimal column protection and performance.

SecurityGuard is compatible with any manufacturer’s GPC column of any particle or pore size. The SecurityGuard is easy to use and connects directly into the col-

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umn without the use of additional fittings that can decrease column performance.

The cartridges can even be double-stacked for added protection. The new cartridges are offered in economical three-packs.

Contact details Laxmi Cyber City, Ground Floor, B Block, Survey no: 10 Kondapur, Hyderabad 500 084 Tel: 040-3012 2400 Fax: 040-3012 2411 indiainfo@phenomenex.com

What is glass?

Glass is a naturally occurring material that consists of around 70 - 80 weight per cent of natural sand (SiO2). As this pure sand (quartz, silica) is too hard and too expensive to melt and be formed into containers, substances that soften the glass and make it easier to convert are added. These substances can be sodium (Na), potassium (K), barium (Ba), magnesium (Mg) and / or calcium (Ca). Also, in order to stabilise the glass structure, boron (B) and aluminum (Al) are added to the composition. So far in general all glasses used for pharmaceutical applications contain at least Si, B, Al, Na and Ca. The remaining elements are individual to the glass supplier. The special fact about glass is that it possesses an amorphous structure which means that the atoms in the glass network are not arranged in perfectly symmetrical way but more chaotic. This leads to some unique properties like e.g. a high transparency.

Why do we have to use a type I glass for parenteral applications?

Many of the new developed drugs are biotechnologically produced drugs that resemble biological molecules. This can be vaccines, monoclonal antibodies, special antibiotics, hormones, enzymes, DNA-recombinant molecules etc.

Biological molecules are often quite sensitive to oxygen, water vapor and / or pH shifts in solution which is why a strong interaction with the glass packaging material should be avoided. In worst case these interactions might lead to a degradation or malfunction of the drugs which is not acceptable. Type I glasses have the highest quality not only in terms of chemical stability but also in terms of temperature stability. This is what makes type I glasses the best choice for parenteral packaging.

(To feature in this column, email your queries to Dr Bettine Boltres ,SCHOTT AG: bettine.boltres@schott.com)

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December 16-31, 2014

PHARMA ALLY

Praj HiPurity Systems introduces BioWiz Smart Bioreactor PRAJHIPURITY SYSTEMS (formerly Neela Systems), Praj Group Company, introduced ‘BioWiz’ Smart Bioreactor, which will help the biopharmaceutical industry meet requirements of various bio processes in laboratory, pilot and commercial units. BioWiz Bioreactor benchmarks international standards and delivers superior operational features and advantages required in today’s global pharma industry. The ‘Smart’ aspect of this bioreactor lies in the various innovative and smart features.

The key features that distinguish BioWiz Smart Bioreactor by PrajHiPurity

Systems (PHS):◗ Cost effective design to meet the exact requirements of the pharma industry ◗ Designed as per International Standards like cGMP, GEP and GDP ◗ ‘Golden Batch’ concept for real time comparison of process parameters ◗ Advance automation – PLCSCADA based system ◗ In-built safety parameters

Web based remote monitoring Apart from BioWiz Bioreactor, PHS also introduced new models of its ‘Glacier’ Water System. ‘Glacier’ is used to generate pure, sanitised water

for pharma and biotech applications. Advanced features have been added to this system like ‘one touch’ sanitisation operation, complete plug and play operation, easy access for O&M with reduced footprint.

Contact details Praj HiPurity Systems Solitaire Corporate Park, Unit No. 1211, 1st Floor, CS No. 131A-1/A, Guru Hargovindji Marg, Andheri (E), Mumbai 400093.

India Tel: 91-22-40888444 Fax: 91-22-2874 7129 Email: info@PrajHipurity.net

TO ADVERTISE IN EXPRESS PHARMA, CONTACT: 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9710022999 Fax: 044- 28543035 Email id: yuvaraj.murali@expressindia.com HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Ltd Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com

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Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com KOCHI Yuvaraj Murali The Indian Express Ltd Ground Floor, Sankoorikal Building, Kaloor – Kadavanthra Road Kaloor, Kochi – 682 017 Mobile: +91 9710022999 Email id: yuvaraj.murali@expressindia.com COIMBATORE G.M. Khaja Ali The Indian Express Ltd No. 205-B, 2nd Floor, Vivekanand Road, Opp. Rajarathinam Hospital Ram Nagar Coimbatore- 641 009 Mobile: +91 9741100008 Email id: khaja.ali@expressindia.com

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

BUSINESS AVENUES

EXPRESS PHARMA

Creative and

reliable

?

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

Aroma. Texture. Sweetness.

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

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

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

EXPRESS PHARMA

December 16-31, 2014 33

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We care for your family . . .

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

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

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

Papain Pepsin Pancreatin Protease ( acid / alkali)

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

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December 16-31, 2014

Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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December 16-31, 2014 35

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EXPRESS PHARMA

Optical Particle Analyzers

The CAMSIZER P4 is the new generation of the well-proven CAMSIZER system with patented Dual Camera Technology.

The new analyzer offers improved performance and extended functionalities. n Extended measuring range from 20 Îźm to 30 mm n Faster hard- and software record more particles per second n Particle library and 3D Scatter Plot Software

www.retsch-technology.com VERDER SCIENTIFIC PRIVATE LIMITED | 1-2-45/1, 2nd Floor, Street No: 2 Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@verder-scientific.co.in

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Sterile Packaging Products

EXPRESS PHARMA

Chemical & Biological Indicators

Wrapping Crepe Paper & Non Woven SMMMS Paper

Amcor Sterilization Reel Bowie - Dick Test Pack & Sheets

Autoclavable Tape & Dry Heat Tape

Class 5 Integrator & Class 6 Emulators

Class 4 Multiparameter Indicator

Container Seals

Self Contained BI (Steam & EtO)

Pro Amp

Spore Strips (Steam, EtO)

Spore Suspension & Spore Ampoule

SS Coupons

Sealing machine with & without Printer

Seal Check Strip

Veridoc (System for labeling & documentation of sterile barrier systems)

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

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December 16-31, 2014

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PHARMA LIFE

ENGAGING THE NEW AGE EMPLOYEE The role of an HR department is pivotal for any company's success. Yet, employee engagement programmes tend to be out of sync with the aspirations of the new age employee

BY USHA SHARMA

T

he human resource (HR) department is an important asset of an organisation. It helps companies in building a team of highly talented professionals and procedures that are pivotal for success. Over a period of time, the role of HR has also evolved to include a lot of responsibilities.

Initially, the key role of HR heads was to recruit the right candidate for a job/position and retain them. Today, the key functions of the human resource management (HRM) team include recruiting people, training them, performance appraisals, motivating employees, improving workplace communication, ensuring workplace safety and much more. In the current scenario, more emphasis is also given to training and engagement programmes to inspire the employees to enhance their

46 EXPRESS PHARMA December 16-31, 2014

knowledge to ensure career growth. This, in turn, helps motivate and encourage employees in constantly delivering productive results. Over time, companies have also adopted better technologies to help implement the expanded role of the HR department.

Archana Dubey-Mitra, Vice President-International Marketing, Bal Pharma compares today’s trends with traditional methods and says, “Earlier days were far different from today’s scenario. It was just the starting period for the (pharma) industry. Companies were not very aggressive or the competition was not very high. Now, the whole culture stands changed as the competitive spirit is being forced upon (employees). In earlier times, flow of information was restricted whereas today it’s just a click away. With increased exposure and handy technology, HRM has emerged as an important tool for organisations' recruitment and retention strategies.”

Certainly, advanced methods and technologies have

helped in simplifying the procedures and making them more accessible.

N Ahmedali, Managing Director, Cornucopia has over 40 years of experience in HRM in India and in the Asia-Pacific region.

Commenting on the different practices followed by various HR heads as engagement practices Ahmedali says that in the 70s and 80s, there was a high degree of employee engagement in the pharma industry. The industry and its professionals were respected.

Compared with other industries, the pay was good and the customers, i.e., the doctors respected the pharma profession.

In this scenario, Ahmedali comments, “Naturally, not very deep solutions had to be developed or implemented in order to gain employee engagement.

It was sufficient if one was able to hold down these elements with a reasonable balance and equilibrium and the automatic result would show up in terms of engagement.”

The impact of employee engagement can manifest itself through productivity and organisational performance, employee retention, customer outcomes, advocacy and organisation’s overall image Archana Dubey-Mitra, Vice PresidentInternational Marketing, Bal Pharma

Sharing similar observations, Divakar Kaza, President, Human Resources, Lupin says, “There has been a huge shift in the nature and behaviour of employees in the 1970s-80s to today and that has caused this paradigm change in the kinds of benefits and activities that organisations undertake today, as opposed to yesteryears. In the erstwhile period, employees really just needed to be ‘well-looked after’ and in doing so HR was appreciated for designing and implementing a bouquet of employee welfare activities. However, today’s (largely) millennial and GenY workforce

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is far from that.”

Global economic trends are the biggest reason for this change. Aditi Kare-Panandikar, Managing Director, Indoco Remedies observes, “In the late 70s and 80s, due to limited options and constraints in economic growth, employees would join one organisation and would retire from the same organisation and hence the issue of attrition did not figure. However, post globalisation, growth prospects brought in an overwhelming change in the job market. This gave an opportunity to the employees, wherein the industry became more

Employee engagement has become imperative for pharma companies to have scientifically designed employee engagement programmes that are well implemented N Ahmedali, Managing Director Cornucopia

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PHARMA LIFE

competitive and thus came the issue of employee retention.”

Moving towards a tech-driven era These macro-economic trends have resulted in a scarcity of talented manpower in the industry.

As Bhavin Mukund Mehta, Director, Kilitch Drugs India reasons, “There is competition between the companies for top hires. Demand for talents made it necessary to have something which will make the employee feel attached with the employer.

Employee should be highly absorbed into the organisational culture and enthusiastic to work.”

Thus HRM has caught the attention of promoters like Kare-Panandikar who notes, “The HR function has gone beyond the process of recruitment and support function and has achieved the status of being a strategic partner for building a team of working professionals for the organisation.”

Pawan Chaudhary, Chairman and Managing Director, Venus Remedies emphasises on how technologies have evolved and helped in changing perspectives, “Unlike in the 1970s - 80s, now companies are more forthcoming and transparent about their vision and mission. Thanks to modern-day technology, every single information about the company is available to employees. As a result, they feel more informed and involved with the organisation like a family member, which motivates them to work hard to meet the objectives and goals of the company.”

However, technology is a double edge sword: easy accessibility and availability of information in the public domain has also encouraged employees to tap better opportunities. This has caused another HR bottleneck. Kaza feels that these better avenues for growth resulted in many challenges for the HR department explaining, “Today’s employees are hungry for growth, recognition and challenges and strongly express their desire to be ‘groomed, developed and rewarded’. And HR teams are on their toes in designing and then redesigning talent management strategies,

48 EXPRESS PHARMA December 16-31, 2014

In the erstwhile period, employees really just needed to be ‘well-looked after’ and in doing so HR was appreciated for designing and implementing a bouquet of employee welfare activities Divakar Kaza, President, Human Resources, Lupin

competency models, reward programmes and engagement initiatives, that are groundbreaking and highly inspiring.”

As time has brought about a change in the mindsets and attitudes of people, the importance of the HR department has grown significantly.

Effective HRM Many other sectors have understood the importance of employee engagement programmes quite early. Take for instance, J Willard Marriott, Managing Director, Marriott Hotels’ quote, “If you take care of your employees, they take care of your guests. When guests are happy, they come back to your hotel and business takes care of itself. Thus the importance of having happy employees who are satisfied in their jobs is key. In the boardroom, even chief experience officers (CXOs) do not undermine the

value of human capital and the importance of engaging with them positively and productively. This is critical in the pharma industry as well. As Chaudhary of Venus Remedies explains, “Being a research and development-driven company, we cannot compromise on talented professionals who can help us realise our objectives. It is impossible for any pharma company like us to grow without employees who strive for excellence to achieve their goals in life. Hiring and retaining such ambitious employees is a tough task.”

HRM is based on three pillars — diversity, talent management, and personnel systems.

Mehta suggests, “In today’s business world, we can split functions of HR department into two parts ie; HR-Administration and HR-Leadership and organisation. HR administration deals with managing compensation and benefits. There is a crucial

link between compensation and the right talent. Compensation and benefits design is core to the employee value proposition and the employer brand.”

HR leadership involves helping the topmost management improve people capabilities. HR leaders need to work towards identifying the employee skills needed for business success, leading talent development, designing organisations to deliver results, fostering a culture of agility and responsiveness, and leading change efforts.

“Keeping in mind the challenges faced by the Indian pharma companies, the HR department is extremely relevant to ensure empowerment of employees and their careers through training, development and growth opportunities that will sustain growth,” says Kare-Panandikar. As she continues, “As part of its key deliverable, an active HR department

HR function has gone beyond the process of recruitment and support function and has achieved the status of being a strategic partner for building a team of working professionals for the organisation Aditi Kare-Panandikar, Managing Director, Indoco Remedies

PHARMA LIFE

must recognise the impact of the outside environment on the organisation, measure the impact of the competition on the dynamics of the employment market and integrate the overall organisational strategy and functional strategies, apart from initiating engagement programmes.”

Attrition is a major challenge faced by HR personnel in today's competitive market and one way of tackling this challenge is to have effective employee engagement activities which would open up line of communication.

“Today’s HR activities focus lies on engagement value proposition that creates engagement drivers, systems and strategies including leadership, communication, work environment, teamwork, career development, rewards and recognition and work-life balance,” KarePanandikar adds.

The role of an HR department is to ensure that the employees stay connected with the organisation and feel free in sharing their goals, fears and conflicts. However, often employees face difficulties in approaching their HR personnel due to a lot of reasons such as lack of daily engagement, lack of open communication lines and pre conceived notions. As Kare Panandikar highlights, “In the process of organisation development, one needs to have a clear understanding of business perspective and human behaviour.

Human behaviour is a science for which one needs to have the understanding and knowledge of the subject and hands on experience which differentiates HR from any other support functions.”

If HRM is so crucial to a company’s performance, then it follows that companies need the right HR professionals who are up to the task. Speaking about the desired orientation of HR personnel, Ali emphasises, “We need to understand that this is a knowledge world. We also need to realise the fact that HR is essentially a facilitating function rather than a frontline one. Several of the conventional HR matters are known to the heads of other line functions. The difference essentially happens when

50 EXPRESS PHARMA December 16-31, 2014

HR as a function is not able to appreciate the needs of those who produce, sell and makes the company laugh to the bank. Hence, a need has arisen for HR function to have full knowledge of the business, in its entirety.”

Therefore he concludes that, HR managers “need to become generalists than HR specialists. Under those circumstances alone will the HR profession be able to appreciate the needs of other stakeholder functions. If that can be addressed, the differences will automatically narrow down if not eliminated. It is also important to consider that conflicts are a part of life. We need to make the workforce, every one of them, realise the psychological part of conflicts and conflict resolutions.”

Key components of employee engagement As per a survey and analysis of the iOpener database, happiness and well-being are the two most important needs of every employee. Happiness at work is counted in terms of words of appreciation, recognition, respect, encouragement, time taken to complete a task and issues like leave. It plays a very important role in retaining the employees for a longer span and ensuring their loyalty to the company.

Chaudhary mentions, “Today’s generation looks for a job which can define them, help them contribute in the growth of the company and give them a great sense of purpose.

Pharma companies should strategise their HR plans around these aspects to retain world-class professionals who can help them achieve new heights.”

“Pharma companies do not have an alternative to having HR engagement programmes.

Also, the HR departments of today are key strategic partners in their organisation’s short and long-term strategies.

Engagement programmes hold significant value in light of retaining the talent particularly by pharma companies as also by other

There is a crucial link between compensation and the right talent.

Compensation and benefits design is core to the employee value proposition and the employer brand Bhavin Mukund Mehta, Director, Kilitch Drugs

Pharma companies should strategise their HR plans around these aspects to retain world-class professionals who can help them achieve new heights Pawan Chaudhary, Chairman and Managing Director, Venus Remedies

sectors in general. But it has been found that pharma companies are more receptive and forward thinking when it comes to putting tools and mechanism in place to help in rising engagement levels,” feels Kare-Panandikar.

HR engagement activities should be directed towards organisational development as well. Such initiatives aid in higher productivity levels among employees and also add to their attachment and passion towards the organisation. It is an established fact that employees turn out to be more productive if they feel fulfilled in their jobs.

Moreover, they tend to align with the organisation’s longterm goals and thereby help in achieving a good retention level and productivity.

Ali emphasises, “It has taken a wider scope. It has become imperative for pharma companies to have scientifically designed employee engagement programmes that are well implemented.”

“Increasing competition to hire top professionals, rising demand for candidates with specialised experience in science and research and the need to provide job stability to employees are the factors that have prompted pharma companies to come up with such HR engagement programmes that an employee cannot resist being a part of your company,” says Chaudhary.

Dubey-Mitra opines, “The impact of employee engagement can manifest itself through productivity and organisational performance, employee retention, customer outcomes, advocacy and organisation’s overall image. So it is important to continually understand and encourage employee engagement in the workplace.”

In the current context, HR has become a strategic partner and performs four major functions like strategic HR, operational HR, industrial relation and compliances. These are the areas where HR professionals need

specialised skills and expertise which differentiates HR portfolio from the other departments in the organisation.

“Gone are the days, when HR was only restricted in managing personnel records and administering healthcare and welfare schemes. Today, HR is able to comprehend the business context as efficiently as any other mainstream function of the organisation and the CHRO is able to forecast, predict and devise strategies that have tangible impact on business results, like any of their counterparts within,” spells Kaza.

With the realisation that HR adds real business value to the organisation through the work force it hires for the company, other functions with the company too give it due importance instead of looking on it merely as a ‘necessary evil.’

As Chaudhary says, “The other departments should not consider the HR department as an isolated one because nowadays this department is accessible to all other departments when it comes to sharing information, resolving employees’ grievances, etc. Other departments should cooperate with the HR department to spread the corporate culture of the organisation and maintain discipline.

All departments of an organisation should work hand-in-hand to achieve the common goals of the company.”

The way forward The HR department should clearly define the organisational goals, create opportunities for employees to enhance their skills from time-to-time for their professional growth and recognise and reward their performance so as to bring out the best in them. The HR team also helps in maintaining a safe, clean, healthy and employeefriendly working environment.

Thus, it is imperative for companies to set up a strong and effective HR department. Employees are the real assets of an organisation and rewarding them appropriately provides both encouragement and motivation. u.sharma@expressindia.com

PHARMA LIFE I N T E R V I E W

‘It is the most comprehensive healthcare and lifesciences management programme in India’ Dr (Prof) Ajit Parulekar, Dean—Healthcare Management, Goa Institute of Management talks about their newly introduced PGDM course in healthcare, its USPs, GIM’s growth strategy and more, in an interaction with Lakshmipriya Nair GIM has introduced a Healthcare MBA (PGDM) programme. Tell us about its USPs? USPs of this programme are: comprehensive healthcare and lifesciences management focus; emphasis on hands-on learning; and strong industry connect. It is the most comprehensive healthcare and lifesciences management programme in the country. All the others, over 100 healthcare management programmes, either focus on hospital administration, pharma management or public health management. We see a convergence happening in the healthcare and lifesciences sector and this is something that we have corroborated with senior healthcare industry leaders. The programme at GIM allows students to get a bird’s eye view of the entire industry and appreciate the interdependence between various parts of this industry.

This programme was conceptualised under the guidance of a steering committee comprising senior industry leaders from pharma, medical devices, hospitals, IT/ consulting, public health and senior academicians.

Two unique initiatives that provide high emphasis on hands-on learning are the Know Your Healthcare Provider (KYHP) programme in the first year and the Give Goa Health initiative in the second year. As part of the KYHP initiative, each first year student (in small groups) spends one day every week mentored by faculty in an healthcare environment in Goa.

They work on live projects like conducting a time motion study at a hospital registration or OPD, inventory management at a device company, auditing quality systems or understanding manpower planning/allocation. For the KYHP initiative, we have partnered with over 40 healthcare institutions including the Goa Medical College, Siemens Healthcare, Merck, Victor Apollo Hospital, Pfizer, Tulip Diagnostics, Lupin, Manipal Hospital, and the Directorate of Health Services (DHS) – Govt of Goa. As part of the Give Goa Health initiative, our students engage with an NGO working in healthcare in Goa. These include organisations such as Sangath, Voluntary Health Association of Goa, Alcoholic Anonymous, National Institute of Malaria Research and healthcare programmes delivered through PHCs in Goa. The Give Goa Health initiative serves two purposes: to socially sensitise our students and also to give back to the Goan society by way of expertise to healthcare related NGOs, shramdaan, organising healthcare camps and helping raise funds for healthcare initiatives in Goa. The strong industry connect is done through initiatives like: 1) Steering committee that advises the curriculum design 2) KYHP and Give Goa Health initiatives 3) Summer internship programme 4) Eminent healthcare industry practitioners who engage with our students through guest lectures, visiting faculty

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eye care, WHO, KPMG, Pfizer, Wockhardt, Ernst & Young and Narayan Hrudayalaya have addressed these students.

Leading healthcare, lifesciences, IT, insurance and consulting companies participate in the placement process of this programme. For our first batch, offers for summer internship exceeded the number of students.

engagements and workshops/panel discussions.

What kind of response did the course elicit from the students and the industry?

Prior to launching the programme, we conducted an exhaustive study of the best healthcare management programmes across the globe and also undertook a survey of prospective students and employers/recruiters. The response from both prospective students and industry has been very encouraging. Our student body is quite diverse, coming from 17 Indian states and half the students have prior work experience. For the first batch of the programme, we received close to 900 applicants (for 60 seats on the programme). Our students come from varied educational backgrounds including medicine, dentistry, pharmacy, biotechnology, nursing, engineering and also commerce and economics.

Many senior industry leaders from organisations like Apollo, Sanofi, Ranbaxy, Accenture, Johnson & Johnson, Aravind

Are you planning to introduce any more new courses in the near future?

We are expanding into related areas and have conducted several management development programmes, research projects and consultancy assignments in the healthcare-lifesciences space.

The healthcare management dedicated faculty have published numerous books, case studies, journal articles and lay press articles. We have completed consulting/research projects for the Department of Woman & Child Development, Water Resources Development and the Goa Medical College.

We have recently successfully bid to conduct the National Family Health Survey for the Ministry of Health and Family Welfare in four states in India.

What is the growth strategy for GIM in the next five years?

GIM strives to provide quality management education and believes strongly in valuesbased education. The institute currently offers four long duration programmes: a twoyear fulltime PGDM in business management, a part-time PGDM in business management for working

executives, a two-year fulltime PGDM in healthcare management and a PhD in management. The institute also offers short duration executive development programmes and consults with several organisations. GIM has two campuses in Goa: a new stateof-the-art 50 acre campus in Sankhali and a city campus at Ribandar (five km from Panaji) housed in a 350 year old neo-gothic heritage building. In the next five years GIM plans to strengthen its faculty by recruiting to a total faculty strength of 70 members and has also embarked on an ambitious star faculty programme to attract globally renowned management faculty to work at GIM. How does GIM plan to address issues plaguing Indian healthcare education?

Every country in the world is struggling to achieve its healthcare objectives. Most countries are trying to devise and implement region specific Universal Health Coverage plans. Innovation alone seems to be the way forward and this orientation has to come from the classroom. Educational institutions carry a big responsibility in training prospective managers and inculcating an innovation mind-set that challenges existing norms and constraints.

At GIM, we have innovation, creativity and entrepreneurship as an integral part of the curriculum. We have set-up a creativity and innovation centre and are in the process of setting up an incubation centre. lakshmipriya.nair@expressindia.com

EXPRESS PHARMA

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December 16-31, 2014

PHARMA LIFE AWARD

‘Innovation & Excellence’sweep India Pharma Awards 2014 UBM India recognises leading innovators across nine categories UBM INDIA unveiled the winners of the second edition of its annual India Pharma Awards 2014 in Mumbai. These awards honour innovation and excellence in the Indian pharmaceutical industry. Winners were declared across nine categories with around 100 companies participating in this year’s awards.

Dr Reddy’s Laboratories received the award in Operational Excellence — API category; Zydus Cadila Healthcare in Operational Excellence – Formulation; Jubilant Lifesciences in Excellence in Environment, Health & Safety (EHS); ACG Worldwide in Excellence in Packaging Development; Akums Drugs & Pharmaceuticals in Excellence in Contract Research; Piramal Foundation and Jubilant Life sciences in Excellence in Corporate Social Responsibility; Ranjeeta Vinil from Saarathi Healthcare in Emerging Entrepreneur of the Year; Ajit Singh from ACG Worldwide received the Lifetime Achievement Award and Dr JN

Banerjee received the Special Jury Award.

Sudhanshu Pandey, Joint Secretary, Dept of Commerce, Govt of India, “Platform like these recognises people and motivates them to do better while continuing to inspire others.

Last few years have been tough on the pharma sector due to various issues and challenges with regards to regulatory norms.

But we must address these challenges in the right spirit. It is a long way for Indian pharma industry, but we are on the right track. India today boasts of world class facilities. The road maybe tough but we have what it takes to get there.”

Joji George, Managing Director, UBM India said, “Against the backdrop of the global pharma industry increasingly looking at

India for higher quality and low cost pharma solutions, the India Pharma Awards celebrate the thinkers and creators who consistently break new ground in the pharma sector thereby taking the value chain to its next level.”

Dr Sudarshan Jain, Managing Director, Abbott Healthcare Solutions said, “The Indian pharma sector is clearly grow-

ing, making significant contributions to the Indian economy and putting us on the global map.

This sector is redefining itself by moving to ‘next practices’ from ‘best practices’. We see strong thrust in the manufacturing arena in line with our national priority of ‘Make in India.’”

Express Pharma was the knowledge partner for the event.

EP News Bureau-Mumbai

APPOINTMENT

Vyome BioSciences ropes in Dr Ranjan Pai and Dr Richard Buchta Dr Ranjan Pai has joined its Board of Directors and Dr Richard Buchta has joined Vyome as Senior Vice-President of R&D VYOME BIOSCIENCES announced that MD and CEO of Manipal Education and Medical Group, Dr Ranjan Pai, has joined its Board of Directors.

Pai’s venture firm Aarin Capital is an investor in Vyome. Dr Richard Buchta, formerly Head of GlaxoSmithKline’s dermatology unit Stiefel Laboratories in Australia, has joined Vyome as

52 EXPRESS PHARMA December 16-31, 2014

Senior Vice-President of R&D. Pai is recognised as one of India’s top corporate leaders.

As Vyome scales operations and prepares to enter the commercialisation phase, his addition adds tremendous strategic experience to the Board. The globalisation and expansion of the Manipal Education and Medical Group through his

strategic vision is an experience that will serve Vyome in good stead as the company looks abroad for development and licensing opportunities, said N Venkat, Co-founder and CEO. “Vyome is a proving to be a serious innovative play in the life sciences industry, and holds a special place in Aarin’s port-

folio. I am personally looking forward to work more closely with the rest of the board, Shiladitya, Venkat and the rest of their team as the company breaks new ground in markets both in India and abroad,” said Dr Ranjan Pai, Chairman of Manipal Education & Medical Group and Founding Partner at Aarin Capital.

Dr Buchta brings rich specialist experience with numerous patent applications and multiple IND filings in dermatology to Vyome’s senior management team, and this will multiply the company’s capabilities as we enter the regulatory filing stages for our pharmaceutical programmes.

EP News Bureau-Mumbai

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