Express Pharma August 1-15, 2014

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Cover Story Imperative that we build and strengthen the pharma sector: Kiran Mazumdar-Shaw Management Budget 2014: A balanced one Pharma Ally IT @ Pharma Special 1-15 AUGUST 2014,` 40

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CONTENTS MARKET Vol.9 No.19 AUGUST 1-15, 2014 Chairman of the Board Viveck Goenka

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CDSCO ISSUES SLEW OF NOTICES ON CLINICAL TRIALS, DRUG SAFETY

13

MPP SIGNS PACTS TO MANUFACTURE HIV MEDICINES

14

ABBOTT TO SELL DEVELOPED MARKETS BRANDED GENERICS BIZ TO MYLAN

15

ELDER PHARMA TO MAKE ELDERVIT, THRIVE SUPER BRANDS

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro

A Balanced One Express Pharmagarners post budget reactions from keyindustryleaders | P25

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

P19: PRE EVENT th

DIA to organise 9 Annual India Conference

PHARMA ALLY

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THE DATA DELUGE

Sanofi Pasteur dengue vaccine shows reduction in risk of hospitalisation

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‘IT’ IS SAFE

P32: RESEARCH UPDATES

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MOVING TOWARDS AN E-DOCUMENT CULTURE

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‘THERMONET IS A UNIQUE PRODUCT SPECIFIC TO DHL GLOBAL FORWARDING’

P28: CLINICAL UPDATES

Drug improves birth rates for women with ovary disorder

P41: CIO SPEAK IT: Key to progress

PHARMA LIFE

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TSP: REDEFINING PHARMACEUTICAL MARKETING

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JITENDRA TYAGI APPOINTED AS BMS INDIA COUNTRY HEAD

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ABLE CONDUCTS BIRAC SUPPORTED SERIES AT UNIVERSITY OF RAJASTHAN

P43: VENDOR NEWS MEGGLE appoints Signet Chemical Corporation as business partner

P76: INITIATIVES SBI donates MMC to AmeriCares India

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

India’s loss, China’s gain?

I

ndia's drug pricing authority, the National Pharmaceutical Pricing Authority is once again at loggerheads with the industry. Its July 10 diktat to bring certain anti-diabetic and cardiac drugs under price control is not the end; it now has cancer drugs and five other categories in its sights. In fact, the narrow interpretation of Para 19, NPPP 2012 almost seems like a deja vu of the retrospective tax issue à la the Vodafone case.

Industry protests that it is not against pricing controls per se. In her letter to the PMO, shared exclusively with Express Pharma on July 22, Kiran Mazumdar-Shaw, Chairperson, Confederation of Indian Industry -National Committee on Biotechnology points out that the industry is willing and committed to partner the government but questions the 'unilateral fixing of ceiling prices based on an inequitable formula which will only devalue and erode the strength of this very important sector.' (See pages 22-24 of this issue for the full text of the letter) What is even more worrying are indications that these recent moves by the pricing regulator have caught certain sections of the authorities unawares, with ministry mandarins and Department of Pharmaceuticals (DoP) officials struggling to defend the NPPA’s stance. Sources point out that these moves go against the very rationale of India’s drug pricing policy, DPCO 2012, which specifically mentions that the National Pharmaceutical Pricing Policy, 2012 (NPPP-2012) would be restricted to pricing of essential drugs as laid down in the National List of Essential Medicines (NLEM) 2011.

Policy experts point out that NPPA's interpretation of Para 19 is ‘erroneous’ as inter-brand differences in branded-generics/off patent drugs are not indicative of a ‘severe market failure’ as alleged by NPPA. Also, different brands of the same drug formulation cannot be considered 'inter-changeable' as there are bound to be differences in quality. The argument is that larger companies would spend far more on quality control mechanisms than their smaller counterparts and hence all brands of the same formulation cannot be considered 'identical'.

Industry

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As pharmaceutical companies in India gear up for a legal battle on drug pricing,safe and affordable medicines seem to be moving even further away from patients

Pharmaceutical Alliance (IPA), the Organisation of Pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers’ Association (IDMA) first shot off letters of protest to the DoP and the Prime Minister’s Office, as well as met top level officials at the Centre and have now gone the legal route.

Which is probably why the industry feels that this time it has a good legal case to first at least stall implementation of the NPPA’s July 10 notice by getting a stay order pending further discussion. The IPA’s petition in the Mumbai High Court will come up for listing on July 30.

Sources indicate that OPPI too will follow.

IDMA will be seriously considering this option at an executive committee meeting due for July 31.

A domino effect So once again, the regulator and industry are headed for a stand off, eye-balling each other.

Unlike the tug of war on intellectual property, all sections of the pharma industry seem united on this issue. At the heart of such a stand off is the increasing trust deficit between the pharma industry and government.

An industry association chief, who did not want to be quoted as the matter will be subjudice by the time this gets to press, termed the NPPA's stance ‘anti-competitive’ as it will force companies in the highest price bracket to lower their prices, thus encroaching on the midsegment, which in turn will migrate to the lowest price band. This will trigger a fight for survival at the lowest price segment, which will put SME players under severe stress. This is the soft underbelly of any manufacturing industry, and a shrinking SME base will in time erode the competitiveness of the entire industry.

Thus it seems obvious that NPPA’s stance will slowly but surely cripple the pharma industry in India. As Mazumdar-Shaw warns, this will only strengthen external competitors, especially China. This is the ultimate irony.

NPPA's focus is on the patient’s health, but will we end up with a sick industry?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

CDSCO issues slew of notices on clinical trials,drug safety Orders based on expert committee report CENTRAL DRUGS Standard Control Organisation (CDSCO) recently issued a series of notices on clinical trials and drug safety announcing the actions to be taken by the Ministry of Health and Family Welfare. The MoH&FW has finalised these orders after deliberating on the recommendations proposed by an expert committee it had put together, under the chairmanship of Prof Ranjit Roy Chaudhury, to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.

The 14 orders, dated July 3, cover much-debated issues like compensation for trial-related injury/death, design of placebo controlled trials, etc and are still being studied by industry to gauge their impact. Below is a summary of each order.

Renaming of committees According to one of the orders, New Drug Advisory Committees (NDACs) will be renamed as Subject Expert Committees. The members of their meetings will be drawn randomly from large pool of experts. Applications of clinical trials and new drugs will initially be evaluated by the Subject Expert Committees and their recommendations will be reviewed by Technical Review Committee (TRC).

CDSCO will grant approval of clinical trial and new drugs based on the recommendations of TRC.

Grounds for banning of marketed drug It has also been decided that if two or more countries take a drug off their market on

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sensitive or insensitive.

The MoH&FW has finalised these orders after deliberating on the recommendations proposed by an expert committee it had put together, under the chairmanship of Prof Ranjit Roy Chaudhury, to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs grounds of efficacy and safety, then the continued marketing of the drug in India will be considered for examination and appropriate action.

Cell created for coordination with institutes like ICMR The report of the expert committee had pointed out that the CDSCO may need information continuously on postmarketing surveillance of drugs, rational use of medicines, drug utilisation studies and adverse drug reaction monitoring and thus recommended the creation of cell for coordination with institutes like ICMR for sponsoring various studies. The MoH&FW has ordered the creation of such a research unit within CDSCO. A three-member cell, within CDSCO, currently constituting Dr A Ramkrishan, Deputy Drugs Controller India; Somnath Basu, Assistant Drugs Controller India and M Balakumar, Drugs Inspector, all based at the CDSCO headquarters, will coordinate with agencies like ICMR for the conduct of such studies,

Undertaking to file for marketing approval If India participates in global

clinical trials of NCE(s) to be used for diseases prevalent in India, after marketing approval is received in the innovator country or in well-regulated developed country markets, CDSCO's approval should be sought for marketing these NCE(s) in India. After approval from CDSCO, the order specifies that 'these NCEs should be marketed in India speedily, preferably by production within the country'. The order directs all sponsors / clinical trial applicants to provide an undertaking to this effect.

Design of placebo controlled trials The MoH&FW order requires pharmaceutical companies, investigators, drug regulators and the ECs to ensure that the design used in a placebo-controlled clinical trial is appropriate, efficient and ethical and directs NDAC members that only such placebo-controlled trials are considered for approval. This is based on the report's observation that placebo controlled trials are fairly uncommon these days, although there will always be a case for them in special circumstances. Since other remedies are usually avail-

able, there is no reason to deprive a patient of a drug in such placebo controlled trials.

Requirements for trials of generics, biosimilars in India On the subject of requirements of local trials of generics or biosimilars, the decision has bee taken that drugs considered generics and similar biologics (biosimilars) in other countries like the US that have been marketed in such countries for more than four years and have a satisfactory report would be approved for marketing in India after abbreviated trials.

NDAC experts have been requested to evaluate the such applications with these requirements in mind.

Criteria for deciding ethnicity of new drugs With regard to the considerations of ethnicity for approval of new drugs, the MoH&FW order specifies 10 properties of a compound, which make it more likely to be sensitive to ethnic factors, which shall be taken into consideration during evaluation of new drug applications. the same order also specifies another eight factors to considered while deciding whether the available data could be ethnically

Waiver of clinical trial The Ministry has ruled that waiver of clinical trial in Indian population for approval of new drugs, which have already been approved outside India, can presently be considered only in cases of national emergency, extreme urgency, and epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy.

Approval of academic clinical trials Academic clinical research may be approved by the Institutional Ethics Committee (IEC). However, if a new drug is being evaluated or a new use for an existing drug is being evaluated, then approval of the DCGI is needed as per Drug & Cosmetic Rules.

Compensation for injury or death According to the order, the MoH&FW has decided that compensation in case of injury or death discerned at a later stage should be paid to the trial participant Or his/her nominee as the case may be, if any drug-related anomaly is discerned at a later stage and accepted to be drug related.

The order therefore advices all sponsors/ manufacturers/ clinical trial applicants to provide compensation accordingly.

Clinical trials of medical devices The order recognises that clinical trial of a medical device is different compared Continued on Page 13

MPP signs sub-licensing pacts to manufacture HIVmedicines Forges first agreement with Desano, Cipla, Mylan, Micro Labs and extends collaborations with Aurobindo, Laurus Labs and Emcure THE MEDICINES Patent Pool (MPP) announced seven new sub-licensing agreements for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG). The United Nations-backed MPP negotiates licences with key patent holders to speed access of lowcost, generic medicines to developing countries.

To date, the MPP has signed agreements with Bristol Myers-Squibb, Gilead Sciences, F Hoffmann-La Roche, the US National Institutes of Health and ViiV Healthcare for eight antiretrovirals (ARVs) and one medicine for an HIV opportunistic infection.

“With licences signed, four new manufacturers are joining us to speed the availability of crucial medicines, ATV and DTG, to developing countries.

This almost doubles our network of generic partners to ten companies,” said Greg Perry, Executive Director, MPP. “Increased generic competition will ultimately bring prices down and increase availability to allow national treatment programmes to treat many more people in their countries.”

Following its December agreement with Bristol-Myers Squibb for a licence on

The United Nations-backed MPP negotiates licences with key patent holders to speed access of low-cost, generic medicines to developing countries atazanavir, a WHO-preferred second-line therapy, MPP has signed its first sub-licence with a Chinese generic firm, Desano, a supplier of active pharmaceutical ingredients (API) based in Shanghai, and with Aurobindo and Emcure, key manufacturers of generic antiretroviral medicines, for the production of lowcost atazanavir. Increasing access of second-line treatments for HIV is crucial as more people living with HIV develop resistance to first-line regimens.

The WHO estimates there will be more than one million people on second-line treatment by 2016 and many more will need access to these new medicines.

“Aurobindo, a long-time MPP partner, is pleased to help ensure the timely introduction of generic ATV in developing countries,” said Arvind Vasudeva, Chief Executive Officer,

Formulations at Aurobindo.

“This medicine offers new options for people living with HIV who are no longer able to take their first HIV regimens and its distribution in resource-poor settings is crucial.”

Three months after MPP signed ground-breaking agreements with ViiV Healthcare on new antiretroviral dolutegravir, the organisation has signed four sub-licences for the manufacture of generic versions of the product for both adult and paediatric care. Laurus Labs, granted an MPP licence to produce five Gilead ARVs in 2012, has been granted a new licence for DTG. Micro Labs, a producer of generics including WHO prequalified ARVs, Cipla and Mylan, a global generics and speciality pharma company, have become new MPP sublicensing partners.

“The HIV field needs new drugs all the time due to the development of resistance and treatment failure,” said Dr Jaideep Gogtay, Chief Medical Officer, Cipla. “Dolutegravir belongs to the new class of drugs integrase inhibitors. This class of drugs brings new options for patients, has advantages over the existing drugs in terms of high efficacy and also brings down the viral loads rapidly. Access to the medicine in developing countries will make a major difference to the lives of HIV/AIDS patients living there.”

“Mylan is an established leader in ARVs with a global portfolio of 43 high-quality products. In continuation of our commitment to providing access to a comprehensive range of highquality, affordable ARV medicines, Mylan is pleased to work with MPP in sub-licensing a new molecule Dolutegravir (DTG),” said Rajiv Malik, President, Mylan.

“The new sub-licensing agreements for generic DTG are a welcome development in ensuring that we reach developing countries with a promising new ARV in record time,” said NK Kothari, Executive Director, Micro Labs.

EP News Bureau – Mumbai

Indoco Remedies gets US FDAnod for Goa facility and Drug Administration.

With this approval, Indoco now has six of its facilities, approved by the US FDA. The six US FDA approved facilities include, three for finished dosages, two for APIs and one for analytical.

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“The approval will now facilitate the generic (ANDAs) approvals in the US market and subsequent product launches there. Without doubt, it will also boost the high-margin revenues of Indoco from the remunerative market of

CDSCO issues... to that of drugs or vaccine, as there is no concept of conducting Phase 1 clinical trial to assess safety, tolerability of the medical device. However, the MoH&FW has decided that the procedures for clinical trials approval, accreditations of investigators, sites, Ethics Committee and such other conditions would be similar to the clinical trials of new drugs/vaccines.

Providing ancillary care The MoH&FW has decided that there should be provision for providing ancillary care to patients suffering from any other illness during the trial. Thus all sponsors/ manufacturers/clinical trial applicants have been advised that such ancillary care should be provided to the clinical trial subject for brief illness in the same hospital/ trial site, wherever required.

Three trial-limit for investigators The order states that the number of clinical trials an investigator can undertake should be commensurate with the nature of the trial, facility available with the investigator, etc. However, under no circumstances the number of trials should be more than three at a time.

All sponsors/ clinical trial applicants have been directed to ensure that the above recommendations are implemented and the investigators are not involved in conduct of more than three clinical trails at a time.

Number of phase III trial subjects

US and placing Indoco in the elite league with other International and Indian pharmaceutical companies,” said Suresh G Kare, Chairman, Indoco Remedies.

If Indians have participated in Phase III global clinical trials, the number of participants need to be adequate for considering approval of the drug in India and the order directs NDAC to evaluate applications while adhering to this requirement.

EP News Bureau – Mumbai

EP News Bureau – Mumbai

Approval follows the inspection of both facilities last year INDOCO REMEDIES has received approval from US drug regulator for its sterile facility (plant-II) and solid dosage facility (plant –III) located at Verna in Goa. The approval follows the inspection of both these facilities last year by the US Food

Continued from Page 12

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MARKET

Abbott to sell developed markets branded generics business to Mylan Abbott to get 21 per cent of a newly formed publicly traded company consisting of its developed markets pharma business and Mylan's existing business ABBOTT WILL sell its developed markets branded generics pharmaceuticals business to Mylan for equity ownership of a newly formed entity that will combine Mylan’s existing business and developed markets pharma business, and will be a publicly traded company. Abbott will retain its branded generics pharma business and products in emerging markets. Abbott also retains its other businesses and products in developed markets.

“This transaction provides Abbott with additional strategic flexibility as we continue to actively manage and shape

our portfolio, reflecting our commitment to long-term, durable growth,” said Miles D White, Chairman and Chief Executive Officer, Abbott.

“Our branded generics pharma business will focus on emerging markets, where demographic changes and increasing access to healthcare are expected to drive sustainable growth.”

Following the closing of the transaction, Abbott's branded generics pharma business will focus in emerging geographies where demographics and growing healthcare systems are combining to create an increased rate of patient

Under the terms of the agreement, Abbott will sell its developed markets branded generics pharma business to Mylan for 105 million shares access to healthcare and where the majority of healthcare products are paid for by the consumer.

Under the terms of the agreement, Abbott will sell its developed markets branded

generics pharma business to Mylan for 105 million shares or approximately 21 per cent, on a fully diluted basis, of a newly formed entity that will combine Mylan's existing business and Abbott's

developed markets pharmaceuticals business, and will be a publicly traded company.

The business to be sold operates in Europe, Japan, Canada, Australia and New Zealand and includes approximately 3,800 employees. It includes a broad portfolio of medicines, as well as manufacturing facilities in France and Japan. Abbott will retain its product portfolio and manufacturing facilities in other geographies as well as its manufacturing facilities in the Netherlands, Germany and Canada.

EP News Bureau – Mumbai

High prices hinder access to newer HIVdrugs: MSFreport For middle-income countries the situation is worse, with some countries paying over 12 times more than the lowest known price HIGH PRICES continue to represent a major barrier to affordable access of both new HIV medicines and viral load testing, which is the best way to monitor whether treatment is working, according to two reports released by international medical humanitarian organisation Médecins Sans Frontières (MSF) at the International AIDS Conference in Melbourne.

Scaling up HIV treatment to reach more people in need and ensuring successful treatment in suppressing the virus will require concerted actions by countries to make these critical tools more affordable.

“Nearly 12 million people are now receiving antiretroviral therapy (ART) in developing countries,” said Dr Jennifer Cohn, Medical Director, MSF’s

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Access Campaign. “With people increasingly starting treatment earlier and remaining on treatment for life, patients need better-tolerated first-line treatments as well as affordable second line-therapy for when first-line medicines fail.”

Additional tools to support treatment are needed to ensure the best quality of care. Routine viral load monitoring, which measures the level of HIV virus in the blood, and therefore how well someone is responding to treatment, is one of these tools.

“Viral load monitoring detects adherence problems early which, when paired with counselling and support, can help people stay on more affordable first-line treatment for longer,” said Cohn. “Viral load monitoring also more accurately and

rapidly identifies those people who need to be switched to second- or third-line treatment if their existing regimen is failing.”

The new MSF report Getting to Undetectable, which describes access to viral load testing in India, Kenya, Malawi, South Africa and Zimbabwe, reveals that while these countries aspire to implement routine viral load monitoring, almost none have been able to do this on a wide scale. The report concludes that, among other barriers, the price per test paid by countries is a major obstacle to wider implementation. The report also outlines steps that countries can take to reduce the cost and complexity of introducing viral load monitoring, including better price negotiation, renting instruments instead of buying them,

dropping the more common, but less accurate, CD4 monitoring, and using more efficient sample collection techniques. These steps have been successful in some countries; negotiations have already resulted in price decreases for viral load, with Kenya paying about $10 per test.

Donors, however, need to step up to the plate and provide financing for rolling out viral load in those areas that need it most.

Although roll-out of viral load is slow and incomplete, it is expected to uncover many people who are failing first-line treatment and need to be switched to second-line. Thus, the price of drugs for second-line therapy becomes a critical issue.

MSF’s annual drug pricing report, Untangling the Web of Antiretroviral Price Reductions,

this year concludes that, while the cost of first and most secondline regimens have fallen over the last 12 months, second-line regimens are still more than double the cost of first-line treatment. For middle-income countries the situation is worse, with some countries paying over 12 times more than the lowest known price.

“There are millions of people without access to treatment, and many of those on treatment need to be switched to newer regimens,” said Leena Menghaney, Manager, MSF’s Access Campaign in India. “If we are to get more people on treatment now, countries need to overcome patent barriers that undermine affordable access to drugs.”

EP News Bureau – Mumbai

MARKET

Elder Pharma to make Eldervit, Thrive super brands Self-owned brands, especially in antiinfectives, lifestyle diseases, dermatology and neurology, to get a major boost WITH THE closure of its ` 2,000-crore deal with Torrent Pharmaceuticals involving selling off of more than 30 ethical brands including Shelcal, Elder Pharmaceuticals plans to create a super brand out of Eldervit with product extensions and large scale geographical expansion. Elder Pharma is laying emphasis on expanding the brands remaining with itself post selloff, the chief being Eldervit, a nutraceutical with a current turnover of approx ` 40 crores. Eldervit is a prescription drug which acts as a vitamin and minerals supplement to boost energy.

Says Alok Saxena, Managing Director, Elder Pharma, “In addition to injection form, we are making Eldervit available in capsules, gel capsules and sachet forms to make it acceptable to all age groups. With its new range and aggressive national expansion, Elder hopes to add a million customers every month and make El-

dervit a ` 100-crore brand by the end of financial year 2016 and a ` 300crore brand by FY 2019.”

Another product which is being revamped and upgraded is Thrive, a natural nutritional supplement for fighting chronic metabolic disorders which is likely to generate sales of ` 10 crores in the current fiscal with anticipated growth of 12-15 per cent every year.

Product extensions of Thrive too have been launched in drink, capsules and tablets form.

With a view to capture a larger share of the highly competitive anti-infectives market, Elder is restructuring and expanding its team as also rationalising prices to ramp up volumes.

Anti-infectives like Cefixime-based Formic and Elfi have been registering a growth of more than 12 per cent every year and are expected to grow at 15 per cent annually from now.

EP News Bureau – Mumbai

US FDAapproves Zydelig for three types of blood cancers THE US Food and Drug Administration has approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities).

Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL.

The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell nonHodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is intended to be used in patients who have received at least two prior systemic therapies.

“In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia,” said Richard Pazdur, Director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

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EP News Bureau – Mumbai

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MARKET

Glenmark’s consolidated GVK BIO launches brand revenue increases by CLINOGENT 20.08 per cent Consolidated net profit increases by 43.65 per cent GLENMARK PHARMACEUTICALS announced its results for the first quarter ended June 30, 2014. For the first quarter, Glenmark’s consolidated revenue was at ` 14,869.40 million as against ` 12,382.43 million in the corresponding quarter recording a growth of 20.08 per cent.

Consolidated EBITDA grew by 38.16 per cent to ` 3423.32 million from ` 2477.82 million in the quarter. The consolidated net profit was at ` 1848.46 million for the quarter ended June 30, 2014 as compared to ` 1286.76 million for the previous corresponding quarter registering an increase of 43.65 per cent.

“We have delivered strong results backed by good performances by our India, Rest of the World (RoW), Europe and LATAM businesses. While we outperformed in the Indian pharma market with a growth of over

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Sales for the formulation business in India for the first quarter ended June 30, 2014, was at ` 3,971.59 million as against ` 3,285.83 million in the previous corresponding quarter, recording a growth of 20.87 per cent 20 per cent. Our RoW business led by Russia and LATAM operations bounced back strongly in this quarter with growth rates of over 20 per cent and 30 per cent respectively,” said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.

Sales for the formulation business in India for the first quarter ended June 30, 2014, was at ` 3,971.59 million as against ` 3,285.83 million in

the previous corresponding quarter, recording a growth of 20.87 per cent.

Revenue from sale of API to regulated and semi-regulated markets globally was ` 1,445.26 million, for the quarter ended June 30, 2014 against ` 1,270.94 million for the previous corresponding quarter, recording an increase of 13.72 per cent.

EP News Bureau – Mumbai

To offer bioequivalence studies for generic pharma and late phase patient-based clinical studies for research-based companies GVK BIOSCIENCES has unveiled a new brand CLINOGENT in the clinical development industry. CLINOGENT provides end-to-end clinical development services. From offering bioequivalence studies for generic pharma and late phase patient-based clinical studies for research-based companies, CLINOGENT brings expertise in delivering solutions to complex data analysis and medical communication problems to customers the world over. CLINOGENT will endeavour to provide innovative solutions to all the clinical and scientific challenges that their customers face in the business.

Manni Kantipudi, Chief Executive Officer, GVK BIO said, “CLINOGENT will be a unique clinical development service provider from India, as it will be able to address the clinical needs of both innovator bio-pharma-

CLINOGENT brings expertise in delivering solutions to complex data analysis to customers the world over ceutical and generics companies world-wide. I am confident this step will bring greater focus on delivering innovative and intelligent solutions and will make significant contributions in the clinical development value chain of our customers.”

EP News Bureau – Mumbai

MARKET GROWTH TRACKER

IPM garners ` 6636 crores in June The Mumbai market grew the highest at 24.3 per cent followed by Vidarbha at 21.3 per cent THE INDIAN pharmaceutical market (IPM) clocked ` 6636 crores in June 2014. It has grown at 10.4 per cent in the same month. With the portfolio of Elder getting added, Torrent, moves upto 16th rank in the IPM amongst the corporates.

For the month of June 2014, amongst the top 10, Lupin grew by 20.6 per cent followed

by Sun Pharma at 16.1 per cent and Mankind at 14.8 per cent.

Two corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Akumentis has the highest growth of 54.1 per cent followed by Ajanta at 45 per

cent and Biocon at 44.8 per cent.

Pharmed becomes the 60th biggest corporate in the IPM crossing ` 200 crores driven by a strong portfolio in their space. Amongst the 11-20 ranked companies, Macleods has the highest growth of 29.5 per cent followed by Intas at 26.6 per cent and DRL at 17.4 per cent. Amongst the 51-60 ranked corporates, Troikaa grows at 50 per cent, Apex 40.3 per cent and Panacea 28.7 per cent. Amongst the 61-75 ranked corporates, Corona grows at 45.8 per cent followed

by Serdia at 25.5 per cent and Bestochem at 20.8 per cent

Indian companies have grown at 12.8 per cent versus 2.8 per cent for MNCs. Amongst the top 50 in MNCs, Janssen grew at 12.3 per cent, followed by Merck at 12.2 per cent and MSD at 10.5 per cent.

Under the non-NLEM category, Indian companies are growing at 15.3 per cent whereas MNCs are growing at 5.8 per cent.

The DPCO 2013 containing molecules market was at –5.9 per cent whereas the nonDPCO market grew by 13.1 per cent resulting in an overall growth of 10.4 per cent for June 2014. Unit growth in both the categories grew in positive.

The DPCO 2013 portfolio for Pfizer de-grew at 25 per cent, GSK de-grew at 13.8 per cent and Ranbaxy de-grew by 14.2 per cent.

From therapy perspective, nine therapies have outgrown the IPM growth and 10 therapies have double digit growths.

The respiratory market grew at 7.2 per cent, gastrointestinal market grew at 13.7 per cent whereas the anti-infectives grew at 4.1 per cent. The anti-diabetic market grows at 21.6 per cent and cardiac at 11.8 per cent in chronic business.

The derma market grew by 17.7 per cent.

From regional perspective,

12 regions have outgrown the IPM growth. The Mumbai market grew the highest at 24.3 per cent followed by Vidarbha market at 21.3 per cent.

Two regions had negative growths in June 2014.

Amoxycillin + Clavulanic acid market grows at 8.6 per cent and takes back its number one position whereas Glimepiride + Metformin grows at 37.7per cent at number two.

The markets of Vitamin- D grew by 37.5 per cent, probiotic microbes grew at 40.7 per cent, Levocetirizine + Montelukast by 24.5 per cent, Rosuvastain by 30.5 per cent, Levetirac-

The Standard of Comparison

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MARKET etam by 26 per cent and Telmisartan by 14.9 per cent.

In the anti-diabetic space, there has been significant launches in the Voglibose + Metformin + Glimepiride market and in the VMS space Myoinositol + Folic Acid shows a good spurt. A new launch in a new space Metformin + Myoinositol is seen the market Lantus and Dexorange grows at 27.9 per cent amongst the top 10 brands to be the eighth and ninth biggest brand respectively in the IPM for the month of June 2014. Amongst the brands who have gained ranks include Glycomet-GP (+6), Liv-52 (+7), Skinlite (+9), Zincovit (+18), Galvus Met (+22), Thyronorm (+19), Gluconorm-G (+38), Panderm Plus (+75), Dolo (+47), Omez D (+34), Storvas (+13), Meftal Spas (+18), Dynapar AQ (+136) amongst top 100 brands.

Amongst the top brands in the IPM, Glycomet GP (22.7 per cent), Lantus and Dexorange (27.9 per cent), Galvus Met (46.2 per cent), Skinlite (26.9 per cent), Liv 52 (20.4 per cent), Orofer XT (22.6 per cent) grew fastest amongst top 30 brands over June 2014.

A total of 161 brands were launched in June 2014. Calapure A, Metital and Bestova are the top NIs.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

18

EXPRESS PHARMA

August 1-15, 2014

With Bonus Units at Full Value Val in Crs

(Val in Crs)

Rank

COMPANY

MAT June-14

MAT

MTH

1

1

IPM Sun Pharma

Val (Cr)

MS%

Jun-14 GR%

Val (Cr)

MS%

GR%

77529

100

6.7

6636

100

10.4

4218

5.44

15.8

349

5.26

16.1 11.7

Cipla

2

2

3838

4.95

6.2

315

4.74

Zydus Cadila

3

3

3082

3.97

5.7

258

3.89

7.2

Ranbaxy

4

5

3060

3.95

2.1

242

3.65

4.1 14.8

Mankind

5

4

2759

3.56

5.7

246

3.71

Abbott HC

6

8

2697

3.48

-1.1

220

3.31

-1.1

Glaxo

7

7

2694

3.47

-15.5

226

3.41

-7.0

Lupin

8

6

2621

3.38

12.7

231

3.49

20.6

Alkem

9

9

2403

3.10

9.1

207

3.13

8.0

Pfizer

10

11

2244

2.89

3.2

185

2.79

4.8

Macleods

11

10

2102

2.71

13.3

200

3.01

29.5

Intas

12

12

1975

2.55

14.1

185

2.79

26.6

Sanofi-India

13

13

1942

2.51

0.6

172

2.59

7.7

Aristo

14

14

1902

2.45

14.7

170

2.56

17.1

Torrent

15

15

1724

2.22

2.7

156

2.34

12.0

Glenmark

16

18

1688

2.18

16.7

136

2.05

16.9

Dr. Reddys

17

16

1658

2.14

7.2

147

2.22

17.4

Micro Lab

18

17

1560

2.01

10.6

137

2.07

15.6

Abbott

19

19

1528

1.97

8.4

132

1.99

13.5

USV

20

22

1410

1.82

8.5

115

1.74

3.6

Ipca

21

20

1400

1.81

21.5

123

1.86

28.6

Emcure

22

21

1345

1.73

22.0

118

1.78

23.8

Wockhardt

23

23

1230

1.59

4.7

98

1.48

8.7

Novartis

24

24

1131

1.46

-1.5

93

1.40

-2.6

Alembic

25

25

1064

1.37

10.2

85

1.28

9.1

Zuventus

26

27

831

1.07

3.9

66

0.99

-9.8

Val in Crs

MAT

MONTH

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

77529

6.7

6636

10.4

ANTI-INFECTIVES

12704

0.14

1040

4.1

CARDIAC

9643

8.60

831

11.8

RESPIRATORY

6098

9.99

408

7.2

ANTI DIABETIC

5598

16.42

508

21.6

PAIN / ANALGESICS

5580

4.76

491

9.9

NEURO / CNS

4825

6.99

406

8.3

GYNAECOLOGICAL

4808

3.02

433

10.0

DERMA

4473

13.71

389

17.7

OPHTHAL / OTOLOGICALS

1402

9.96

124

13.1

HORMONES

1302

3.58

106

2.3

ANTI-NEOPLASTICS

1103

30.54

106

34.6

VACCINES

1081

-5.01

83

-14.6

BLOOD RELATED

929

4.99

79

0.5

OTHERS

895

4.95

79

16.1

ANTI MALARIALS

631

2.75

45

3.5

SEX STIMULANTS / REJUVENATORS

433

2.68

35

0.5

STOMATOLOGICALS

349

9.59

32

11.0

MARKET PRE EVENT

th

DIAto organise 9 Annual India Conference It will be held in Mumbai from October 16-18, 2014; the theme for the event will be ‘The Future of Indian Healthcare: Patients, Access and Innovation' DRUG INFORMATION Association (DIA) will organise 9th Annual India Conference in Mumbai from October 16-18, 2014. The theme of the meeting is ‘The Future of Indian Healthcare: Patients, Access and Innovation.’

The programme committee members are Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals Europe, United Kingdom, Madhur Gupta, Technical Officer - Phar-

maceuticals, WHO, India, Prof Ranjit Roy Chaudhury, Chairman, Task Force for Clinical Research, Apollo Hospitals Group.

The programme will include sessions on important topics including patient health safety and compliance for prescription medicine, patient participation in clinical trials, universal health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing, innovations in healthcare solutions etc.

To subscribe: bpd.subscription@expressindia.com

Speakers who will take part in the conference are MK Bhan, Former Secretary, Department of Biotechnology (DBT), Government of India, Vikas Mohan Sharma, Senior Director, Medical Ethics & Research Office of CMO, Quintiles Technologies India, Bhasker Iyer, Divisional Vice President, India Commercial Operations, Abbott Healthcare, Urmila Thatte, Director, FERCI, Prof and Head, Deptartment of Clinical Pharmacology, KEM Hospital, Satish Chandra,

Senior Specialist and Head Clinical Research, TAWAM Hospital (associate of John Hopkins), United Arab Emirates, YK Gupta, Prof & Head, Department of Pharmacology, All India Institute of Medical Sciences, Pooja Sharma, Patient Advocacy Groups, CANKIDS, India, Ajoy Roy, Senior Medical Director and Head Medical Affairs, Parexel, Vivek Ahuja, Director, PATH, Adnan Mahmood, Director- Medical Safety & Clinical Development, Global Patient

Safety, UK, Mira Shiva Founder, Health Action International Asia Pacific, Mira Shiva, Founder, Health Action International Asia Pacific, Vikas Ahuja, President, The Delhi Network of Positive People, Ketho Angami, Executive Member, HepCoN and Barbara Bierer, Senior Vice President of Research; Professor of Medicine, Harvard Medical School Brigham and Women's Hospital, US. EP News Bureau-Mumbai

EXPRESS PHARMA

19

August 1-15, 2014

MARKET POST EVENT

IDMA’s writ petition results in relief for the nutra sector IDMA briefing on impact of Mumbai HC order quashing FSSAI advisory INDIAN DRUG Manufacturers’ Association (IDMA) recently called a press meet to discuss the implications of the June 30 Mumbai High Court judgement which quashed an advisory issued last May by the Food Safety and Standards Authority (FSSAI) for prior product approvals (PA) of dietary food and health supplements already licensed and existing in the market under the erstwhile Food Adulteration Act. Giving more details, Dr RK Sanghavi, Chairman, Nutraceutical Subcommittee and SV Veeramani, President, IDMA explained that the June 30 judgement ruled that the May 11, 2013 advisory ‘has no force of law and is not within the ambit and scope of the power conferred on FSSAI under the provisions of the FSS Act, the Rules and the Regulations framed thereunder.'

The discontinuing of the PA system allows unhindered manufacturing of nutraceuticals, with hopes that the sector achieves a CAGR of 18 per cent.

Daara B Patel, Secretary General, IDMA informed the gathering that IDMA had explored all the alternative possibilities to resolve the issue and support the manufacturers. However, nothing seemed to have worked and even getting appointments to meet the authorities and explain the problems in greater details was difficult. IDMA and some of its aggrieved and affected members ultimately decided to file a suit in the Bombay High Court.

Nutraceuticals have gained importance as the focus has

20 EXPRESS PHARMA August 1-15, 2014

(L-R) Dr RK Sanghavi, Chairman, Nutraceutical Subcommittee, IDMA; S Veeramana, President, IDMA; Ganesh Kamath, Director, Vital Neutraciticals; Daara Patel, Secretary General, IDMA; Sandeep Gupta, Vice Chairman, Neutraceutical Subcommittee, IDMA; Dheeraj Nair, Legal Expert

The FSSAI claimed that the PA system was introduced for the safety of consumers; however, sources at IDMA point out that there is no such requirement for the same category of products in most regulated markets such as US shifted from replenishing nutrients to fight deficiency diseases to the current trend to combat to use dietary food and health supplements to check proliferation of chronic diseases against which there is limited or nil options in modern systems of medicine.

Some examples include the use of nutraceuticals like glucosamine and collagen for joints, omega-3 for heart, diabetes, coenzyme

Q10 for heart.

This trend gave a boost to the nutraceutical sector in India in the early 1990s but this scenario changed when the Food Safety Standards Act of 2006 was implemented which required each product (even those already being consumed) to apply to the central licensing authority for approval.

This system was contrary to global regulations for this

class of products, and besides the approval was subject to bias in view of no established guidelines set to objectively assess the nutraceuticals. As a result, there were largescale rejections of products, including those already being consumed.

This move drew protests from manufacturers of dietary food and health supplements. According to a report by the Confederation of All In-

dia Traders (CAIT), “…the enforcement of this Act in the present form, it will lead to the closure of over 17 lakh Indian food industries and will force unemployment on over 20 million people.”

The FSSAI claimed that the PA system was introduced for the safety of consumers; however, sources at IDMA point out that there is no such requirement for the same category of products in most regulated markets such as US. Any new ingredient included for the first time in a product in the country, and not mentioned in Codex needs to undergo ‘ingredient approval’.

Hence, the FSS Act has already provided a mechanism to ensure safe consumption of products.

Manufacturers of nutraceutical products and IDMA personnel met the relevant FSSAI officials to explain the flaws in the PA system and emphasise upon focusing on the ‘ingredient approval’ system but in vain. As a logical outcome Vital Neutraceutical, one such affected company, and IDMA approached the Mumbai High Court, vide writ petition 2746 of 2013, for seeking relief and deliverance which resulted in the judgement of June 30 which vindicates their stance.

Speakers at the meet clarified that this judgement meant that product-wise approval for proprietary food (nutraceuticals) was never required and now cannot be demanded or enforced. The judgement is applicable for not only the existing ones but all such manufacturers.

EP News Bureau – Mumbai

EVENT BRIEF AUGUST-SEPTEMBER 2014 The Indian Pharmaceutical Association Convention – 2014

9

THE INDIAN PHARMACEUTICAL ASSOCIATION CONVENTION – 2014 Date: August 9, 2014 Venue: NIMHANS Convention Centre, Bangalore Summary: The Indian Pharmaceutical Association will celebrate its Platinum Jubliee this year. IPA and IPA-Karnataka State Branch is organising a seminar on ‘Excellence in Quality -Applying Learning to Practice.’ The seminar is planned for regulatory and industry professionals, community pharmacists and hospital pharmacists and academic professionals and students.

Contact details www.ipapharma.org

PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 2014 in Bangalore from September 25-27, 2014. PharmaLytica 2014 will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. PharmaLytica 2014 will spread over 2,000 sq mt featuring over 100 plus exhibitors. The event will be supported by Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA).

Also, India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organization (ACRO) will support the event.

Contact details Rahul Deshpande Sr. Manager - Projects Tel: +91 22 61727165 Mob: +91 98209 02476 Email: rahul.deshpande@ubm.com TH

DIA’S 9 ANNUAL CONFERENCE Date: October16-18, 2014 Venue: Mumbai Summary: The theme of the meet-

25

PharmaLytica 2014

ing is ‘The Future of Indian Healthcare: Patients, Access and Innovation.’ The programme committee members are Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals Europe, United Kingdom, Madhur Gupta, Technical Officer - Pharmaceuticals, WHO, India, Prof Ranjit Roy Chaudhury, Chairman, Task Force for Clinical Research, Apollo Hospitals Group.

Speakers who will take part in the conference are MK Bhan, Former Secretary, Department of Biotechnology (DBT), Government of India, Vikas Mohan Sharma, Senior Director, Medical Ethics & Research Office of CMO, Quintiles Technologies India, Bhasker Iyer, Divisional Vice President, India Commercial Operations, Abbott Healthcare, Urmila Thatte, Director, FERCI, Prof and Head, Deptartment of Clinical Pharmacology, KEM Hospital, Satish Chandra, Senior Specialist and Head Clinical Research, TAWAM Hospital (associate of John Hopkins), United Arab Emirates, YK Gupta, Prof & Head, Department of Pharmacology, All India Institute of Medical Sciences, Pooja Sharma, Patient Advocacy Groups, CANKIDS, India, Ajoy Roy, Senior Medical Director and Head Medical Affairs, Parexel, Vivek Ahuja, Director, PATH, Adnan Mahmood, DirectorMedical Safety & Clinical Development, Global Patient Safety, UK, Mira Shiva Founder, Health Action International Asia Pacific, Mira Shiva, Founder, Health Action International Asia Pacific, Vikas Ahuja, President, The Delhi Network of Positive People, Ketho Angami, Executive Member, HepCoN. Contact details Drug Information Association A-303, Wellington Business Park - IMarol, Andheri - Kurla RoadAndheri (East) Mumbai - 400 059 Tel: +91.22.67417625 Website: www.diahome.org

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

21

August 1-15, 2014

cover )

Industry has protested NPPA’s move to fix ceiling prices of anti-diabetic and cardiac drugs. In an open letter to Prime Minister Narendra Modi, Kiran Mazumdar-Shaw, Chairperson, CII -National Committee on Biotechnology emphasises the need for trust and equity in the Government-industry partnership and recommends some steps to give the sector a shot in the arm

22 EXPRESS PHARMA August 1-15, 2014

T

he Indian pharmaceutical industry has earned the proud label of being the ‘Pharmacy of the World’ by virtue of being the largest and lowest-cost producer of generic drugs for the benefit of patients the world over.

This sector, which has propelled India into global prominence and leadership, has also made our country an indispensable and integral part of global healthcare.

It is therefore imperative that we build and strengthen this sector so that it can assume an even greater position in global healthcare. The Indian pharma industry is

today worth $20 billion, of which $15 billion is accounted for by exports. It is a matter of pride that one in five, or 20 per cent, of generic drugs in the world are of Indian origin and one in three children are immunised with a ‘Made in India’ vaccine.

This sector must be commended for having built these strengths and capabilities through the zeal and zest of a number of committed entrepreneurs who have painstakingly and consistently invested in both skills and scale over several decades, with very few incentives from the Government.

MANUFACTURING AND JOBS What is even more important is to highlight the role of scientists and engineers in building this important sector. It has

(

THE MAIN FOCUS

IMPERATIVE THAT WE BUILD AND STRENGTHEN THE PHARMA SECTOR thus been a great job creator, providing employment to thousands of scientists, pharmacists, engineers and technicians.

The pharma industry has created a global scale manufacturing sector which has enabled the development of specialised skills and has provided India a globally competitive advantage.

Innovation has also been the hallmark of this sector wherein leading Indian pharma companies have invested consistently in R&D of generic drugs which has paid handsome dividends by way of our global leadership in generics today.

It is important to highlight that this is one sector which has self-financed its investment in R&D and in establishing global scale, state-of-the-art manufacturing facilities.

This sector has also seen the mushrooming of thousands of SME pharma enterprises, which have bolstered the manufacturing capacity of this sector.

IMPACT OF INVESTMENTS IN R&D, QUALITY SYSTEMS AND LARGE SCALE MANUFACTURING A significant difference exists between pharma companies in terms of investments, scope of

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It is vital that we ensure the uninterrupted supply of these essential drugs by large scale manufacturers through viable pricing option activities and overhead costs.

This leads to vast variation in drug prices.

In recent times, the Government through the National Pharmaceutical Pricing Authority (NPPA) decided to examine the vast variation in drug prices and pared them through the imposi-

tion of ceiling prices on 348 essential drugs under the National List of Essential Medicines (NLEM). Instead of factoring in the huge differential that exists between companies based on investmentlinked overheads, the Government merely adopted a simple average price formula which industry believes acts to its disad-

vantage and deters further investments in research and high quality manufacturing and distribution.

The industry is willing and committed to partner the Government in its efforts to meet the healthcare needs of Indian patients through various mechanisms such as rational pricing of drugs and fair market competition, universal healthcare, bulk procurement schemes, special assistance in times of national emergency through CSR initiatives, etc. but questions the unilateral fixing of ceiling prices based on an inequitable formula which will only devalue and erode the

EXPRESS PHARMA

23

August 1-15, 2014

cover ) strength of this very important sector.

The Indian pharma industry is a highly capital intensive and investment intensive sector due to its inherent needs in terms of specialised infrastructure, R&D and quality systems.

You are perhaps aware that India has 370 plants approved by the US FDA, the largest number outside the US. Recently, many Indian pharma companies have received warning letters pertaining to noncompliance and poor compliance to the US FDA regulatory norms. This will entail additional investment in attaining these standards if we are to retain our strong position in the US market.

NPPA PRICING HAS CHALLENGED MANUFACTURING VIABILITY The forced price discounting imposed by NPPA has done collateral damage to our indigenous industry which has only strengthened our external competitors, especially China.

E.g., Indian manufacturers of Active Pharmaceutical Ingredients (APIs) or bulk drugs have found it difficult to compete with Chinese API producers and Indian drug companies are now increasingly importing APIs from China. This has led to the shutting down of many API plants and discontinuance of many important APIs, especially antibiotics.

Additionally, the drastic price discounting imposed on a number of antibiotic drugs have led to their manufacturing being discontinued by Indian companies on the ground of non-viability. This has resulted in drug shortage which will eventually result in the importation of Chinese antibiotics.

This is an extremely dangerous situation that is evolving and must be corrected urgently.

SME pharma companies in India can manufacture limited quantities of essential drugs, but they simply cannot cater to the large needs of our country’s formularies which are depend-

24 EXPRESS PHARMA August 1-15, 2014

The imposition of Minimum Alternate Tax has also been a contentious issue with all SEZ companies. The removal of MAT will help to enhance global competitiveness for the Indian pharma sector. Additionally, the Government should also consider the exemption of duties and taxes on domestic sales of essential drugs from SEZs.

5. CLINICAL TRIALS

The drastic price discounting imposed on a number of antibiotic drugs have led to their manufacturing being discontinued by Indian companies on the ground of non-viability. This has resulted in drug shortage which will eventually result in the importation of Chinese antibiotics ent on large scale production.

Hence, it is vital that we ensure the uninterrupted supply of these essential drugs by large scale manufacturers through viable pricing options.

Based on the above alarming set of challenging factors, I request you Hon’ble Prime Minister, to urgently intervene and take corrective action to revive and resurrect this lifesaving sector. This is a sector of strategic importance for India and one that relies on manufacturing and job creation which are at the core of our development agenda.

RECOMMENDATIONS In order to give the pharma industry a shot in the arm, I request you to kindly review the following recommendations:

1. SUPPORTING CAPITAL INVESTMENT FOR UPGRADING AND EXPANDING MANUFACTURING INFRASTRUCTURE The Indian pharma sector is a highly capital intensive sector.

Over the past decade, the Top

20 companies have invested over ` 25,000 crores in setting up global scale manufacturing facilities. These facilities need to be further augmented through exponential capital investment in the next 10 years. Many of these past investments have been done through high-interest domestic and overseas borrowings.

Foreign currency borrowings have resulted in huge liabilities on account of sharp rupee devaluation that has hurt the balance sheets of several of these companies. Therefore, low-interest borrowings need to be made available for future investments to be made by the pharma industry.

2. R&D INVESTMENTS For India to retain its global leadership, investment in R&D and innovation is paramount. The 200 per cent weighted tax deduction on R&D costs allowed to companies does not permit the inclusion of international patenting and overseas drug development expenses.

This tax exemption should be allowed urgently.

3. DRUG PRICING It is requested that computation of price ceilings should be based on an equitable formula which ensures like-for-like comparisons and factors the quantum of investments. If Return on Investment is denied, any such price formulae will erode huge value for this all-important sector and make business unviable.

4. PHARMA EXPORTS FROM SEZS Unlike other sectors, the pharma industry is not permitted to export drugs and APIs without obtaining international regulatory approval. This process takes on an average two years which denies all pharma units in SEZs nearly two years of 100 per cent Tax Holiday. The SEZ policy has therefore overlooked this aspect which is specific to the pharma sector. It is therefore requested that the pharma sector be compensated by allowing it to choose the starting year of the Five-Year Tax Holiday based on obtaining the required regulatory approval.

If India is to claim leadership in the pharma industry, it is imperative to focus on drug innovation. The current moratorium on clinical trials is severely hampering drug development and instead strengthening external competition which is highly undesirable.

The medical community itself can only be strengthened if it is encouraged to pursue clinical research along with clinical practice. Only when these run in tandem can we see better health innovation and thereby better health outcomes. We therefore request your intervention in lifting the current moratorium and reviving this very important sector which is a large skill-based job creator providing employment to life sciences graduates, pharmacy graduates, statisticians ad IT professionals.

The concerns around ethics and safety pertained to a few trials, which should have been investigated and dealt with by regulators. Unfortunately, the entire sector has had to pay the price for a few errant trials.

Hence, there is an urgent need to resume clinical trials post haste.

The Indian pharma industry has a key partnership role in the Government’s efforts to deliver on its stated agenda of 'Health for All.' Unless there is trust and equity in this partnership, we will lose a huge opportunity in not only fulfilling the medical needs of millions of patients in India but also our leadership role in making a difference to billions of patients around the world.

MANAGEMENT

A Balanced One Express Pharma garners post budget reactions from key industry leaders

‘The budget as proposed will encourage R&D’

T

he budget lays a lot of emphasis on spurring growth in the manufacturing sector. The investment allowance linked to the new investments in plant and machinery are likely to benefit pharmaceutical companies also. The Government has hinted at supporting SEZs. Pharma companies setting up export units should be enthused by this intent, although the devil lies in the details.

To subscribe: bpd.subscription@expressindia.com

The budget as proposed will encourage R&D. The Government has proposed to strengthen biotech clusters. Innovator companies are also

ANAND MEHTA Partner (Pharmaceutical and Healthcare sector group), Khaitan & Co

likely to benefit from the proposed provision for refund of customs duty on the import of scientific and technical instruments. Investigators in clinical trial programmes may now be subjected to service tax with the exemption proposed to be withdrawn. These had been included in the negative list of exempted services. This will make clinical trials more expensive.

The Government has sug-

gested that they will prioritise the ‘Free Drug Service’ and ‘Free Diagnosis Service’. This clearly signifies an increase in Government expenditure in the sector and create potential for demand for manufacturers.

‘Hospitals’ bottom line is sought to be protected. As an example, bio-medical waste disposal service providers are proposed to be exempted from service tax.

EXPRESS PHARMA

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August 1-15, 2014

MANAGEMENT

‘The focus seems to be on higher growth’

O

verall a pragmatic and balanced budget. The new Government has probably tried to balance the fiscal deficit restrictions vis-a-vis the push to be provided to the ailing economy. On one side the Finance Minister has tried to contain the fiscal deficit to about four per cent level, where as on the other side he has tried to provide boost to initiatives like job creation, infrastructure, higher FDI and domestic investments, industrial development, better healthcare and education etc. He has also tried to provide

products. The main focus of the budget seems to be higher growth and job creation through support of PPP programmes and more investment through

RAJESH LADDHA Chief Financial Officer, Piramal Enterprises

support to agriculture and warehousing to improve the supply and storage of agricultural

FDI and domestic savings. The Government has also demonstrated that it wants to promote

‘Issues are more policy related’

T

he issues around the pharma sector are more policy related, with tax measures forming only part of the solution. While the support of the Government toward macro issues like skill development and bridging the infrastructure gap are fairly commendable, issues directly related to the pharma industry were fleetingly mentioned.

The clarity around the role of the Central Drugs Standard Control Organization (CDSCO) and Central Drug Research Institute (CDRI) and the current regulatory ambiguities were much desired, today. Initiatives

and Free Diagnosis Service were mentioned as priority were not substantiated enough from a procurement perspective, leaving behind

use of newer technology whether it is use of broadband or solar energy. The budget has also tried to provide inclusive growth through development of underdeveloped regions e.g.

Northeast and Jammu and Kashmir. It has also provided for development of underprivileged section of society.

Key initiatives pertinent to healthcare and pharma ◗ More focus on education and health ◗ Sanction of more IIMs and IITs

T

he budget has drawn some broad strokes on the canvas showing the Government’s intent in the coming years. The budget has given

Partner, Head of Advisory, Head - Life Sciences, KPMG in India

ambiguity around execution.

In a nutshell, the budget did leave much to be desired in terms of answering the many questions that all the pharma industry stakeholders have in mind.

M

26 EXPRESS PHARMA August 1-15, 2014

existing healthcare infrastructure. Setting up of 15 model rural health research centres will be an important step in providing access to quality healthcare.

Strengthening the network of AIIMS and launching new initiatives like Free Drug Service and Free Diagnosis Service are steps in the right direction. It

has taken initiatives in proposing to set up two national institutes for early diagnosis and treatment of TB patients. The decision to set up new drug testing laboratories and strengthening 31 existing state laboratories is a noteworthy step, which will provide assistance to the States’ Drug Regulatory and

◗ Introduction of new accounting standards in line with IFRS by FY 16 ◗ Implementation of GST during current fiscal year These measures will help boost the global investors’ sentiment and may improve the capex cycle going forward. However, much needs to be seen when the real implementation starts.

additional funds to middle class and the senior citizens, provided assurances to manage the fiscal deficit and has shown the intention of the government to create opportunities for new investments. Overall this was a positive budget considering the fact that this government has been in power for about a month only.

ARJUN HANDA Managing Director and Chief Executive Officer, Claris Lifesciences

‘Healthcare has received special attention’ odi Government has addressed the current challenges facing the Indian economy by taking key measures. Healthcare has received special attention in the budget and the Government has put greater emphasis on providing quality affordable healthcare and strengthening the

General provisions

‘Overall this was a positive budget’

UTKARSH PALNITKAR

around developing clusters for biotech and promoting global partnerships to strengthen generic engineering and biotech will also help the biotech sector in the country. The Free Drug Service

◗ More hospitals in form of AIIMS

Food Regulatory Systems.

DR RAJIV MODI Chairman and Managing Director, Cadila Pharmaceuticals

MANAGEMENT

‘The budget has generated a lot of positivity and optimism’

‘On the whole the Budget is welcome’

T

T

here have been a couple of tangible measures announced for the healthcare, pharma and biotech sectors which justifies the positive buzz for these sectors. For instance, the proposal to set up 12 new medical colleges, plus an AIIMS in every state, will add to the healthcare talent pool.

The proposal to set up a ` 10,000 crore venture capital fund for start-ups, incubators and accelerators, should also have a positive impact on this sector as it should encourage technology start ups and thus create more job opportunities.

For instance, Bangalore could possibly become the hub for mobile/mobile application de-

isting biotech hubs, at Bangalore and Faridabad and this will again create exciting job opportunities in these cities.

The Finance Minister has

V SURESH Executive VP and National Head Sales, Naukri.com

velopment in the healthcare sector, opening up new avenue for job creation.

A proposal which will have a more direct positive impact is the creation of two new biotech clusters in Pune and Kolkata as well as the scaling up of two ex-

also proposed global partnerships to transform The International Centre for Genetic Engineering and Biotechnology (ICGEB, New Delhi) into a world-class centre for excellence genetic and biotech Research.

‘No incentives were given to the pharma industry’

T

he budget fell short of expectations while the market was looking forward to some meaningful reforms. What we found instead, were a set of proposals that were neither bold, nor clear.

The budget is unequivocally positive for the infrastructure, manufacturing and banking sectors; however, no incentives were given to the pharma industry. There is a need for the country to have universally accessible, affordable and effective healthcare and in order to do this, it is imperative for the government to offer tax incentives to encourage innovation in R&D and assist in developing and honing Indian IP — none of which has been addressed.

Having said that, there is, some renewed focus on healthcare in rural areas.

Setting up research centres on TB towards affordable healthcare, along with four new AIIMS is a welcome move but

he budget doesn’t have any special announcements with respect to the pharma industry except strengthening of drug testing

what really needs to be done is the expansion of the healthcare budget, new investments to create medical infrastructure and ramp up the existing public

RAMESH SWAMINATHAN

SV VEERRAMANI President, IDMA

laboratories, formation of rural health centres and bio-tech clusters in Kolkata and Pune.

The proposal to revise the capital ceiling for definition of MSME as well as committees

This year’s budget is a let-down, with too much promise and little depth

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the manufacturing sector, formation of export promotion mission, skill India programmes, etc. On the whole, the budget is welcome in the sense it doesn’t have any negatives for the pharma industry.

‘Nothing major was announced’

I

feel the Government has done a commendable job with the Union budget considering that it been in office barely for six weeks.

Chief Financial Officer, Lupin

health structure, investments to promote local manufacturing and research — which was missing in the budget. The indicated implementation of GST will of course be positive as and when it happens. Furthermore, while the FM spoke about the government’s commitment to SEZs to revive and boost economic growth, there was no clarity provided on the specifics. This year’s budget is a let-down, with too much promise and little depth.

to be set-up for SME developments can help the pharma SMEs. Only after seeing the fine print, we can evaluate the extent of benefit to the pharma industry on announcements like reduction in basic customs duty on certain chemicals, 15 per cent capital subsidy for investment beyond ` 25 crores in

lay out a directional road map for achieving a higher rate of growth, reigning in inflation and curbing the fiscal deficit to a reasonable level over the next few years.

While, the Finance Minister announced some key measures to enhance governmental participation in healthcare over the next few

DR HABIL KHORAKIWALA Founder Chairman and Group CEO, Wockhardt

Even though the Finance Minister has not had too much time to develop the budget, he has managed to

years, nothing major was announced with respect to the pharma industry, which is a little disappointing.

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August 1-15, 2014

RESEARCH CLINICAL UPDATES

Sanofi Pasteur dengue vaccine shows reduction in risk of hospitalisation Detailed analysis of data from the phase III dengue vaccine efficacy study shows 88.5 per cent reduction of dengue haemorrhagic fever SANOFI PASTEUR, the vaccines division of Sanofi announced the publication in The Lancet of the detailed results of its first landmark phase III dengue vaccine efficacy study conducted in five countries in Asia. Results show overall efficacy against symptomatic dengue of 56.5 per cent* in children aged two to 14 years old after a threedose vaccination schedule.

Importantly, analyses show an 88·5 per cent* reduction of dengue haemorrhagic fever, the severe form of dengue, according to the WHO criteria1.

The study also showed a clinically important reduction in the risk of hospitalisation due to dengue by 67 per cent* during the study. The favourable vaccine safety profile observed during the 25 month follow up of the phase III study in Asia is consistent with the safety profile documented in other studies (phase I, II, Iib).

The study confirmed the very high burden of disease by revealing that one in twenty children in the control group suffered from dengue each year, which was three-fold higher than initially expected.

Each year, an estimated 500,000 people, including children, have severe dengue requiring hospitalisation. 2 This puts huge strain on hospitals and health care systems during outbreaks.2 “The results of this first phase III study show the potential of the vaccine to have a significant impact on public health,” commented Dr Maria Rosario Capeding, study principal investigator, Research Institute for Tropical Medi-

28 EXPRESS PHARMA August 1-15, 2014

The study confirmed the very high burden of disease by revealing that one in twenty children in the control group suffered from dengue each year, which was three-fold higher than initially expected cine, the Philippines. “The threat of severe dengue disease creates fear in the community. The vaccine’s impact on preventing dengue haemorrhagic fever is noteworthy.

A vaccine that is able to avoid the personal suffering and reduce this significant health burden would change the lives of millions.”

Safety analyses (solicited reactions, unsolicited events and Serious Adverse Events SAEs) during the study showed similar reporting rates between the vaccine and control groups. SAEs were consistent with medical disorders in this age group and were mainly infections and injuries. Safety is continuously reviewed by an independent data monitoring

committee. To date, 27,000 children, adolescents and adults have been vaccinated with three doses of the candidate dengue vaccine throughout the clinical studies.

“The high efficacy observed against severe dengue and the reduction of hospitalisation by two thirds is an extremely important public health outcome. Furthermore, this dengue vaccine continues to meet the highest safety expectations, which is very reassuring,” commented Professor Duane Gubler, Professor and Founding Director of the Signature Research Program on Emerging Infectious Diseases, Duke-NUS Graduate Medical School, Singapore, and Chairman of the Partnership for

Dengue Control.

"These pivotal phase III vaccine efficacy study results take us closer to our ambition to bring the first vaccine against dengue to the world," said John Shiver, Senior Vice President, R&D, Sanofi Pasteur. “After more than 20 years of commitment in collaboration with the scientific community, we are on course to make dengue the next vaccine-preventable disease. The public-health implications of a future dengue vaccine are significant and these findings are an important stride towards meeting the WHO’s strategic goals of reducing dengue mortality by half and morbidity by at least 25 per cent by 2020.”

The four dengue virus

serotypes have circulated during the study with a distribution representative of the epidemiology in Asia. The measured efficacy of the vaccine during the 25 months observation of the study is consistent across countries and appears to vary by dengue serotype (between 34.7 per cent and 72.4 per cent) and by age. The results of this first, large-scale efficacy study will be supplemented by results from a second, large-scale phase III study in Latin America and the Caribbean, including more than 20,000 children and adolescents aged nine to 16 years old from Brazil, Colombia, Honduras, Mexico and Puerto Rico. * 56.5% (95% CI: 43.8-66.4); 88·5% (95% CI 58·2 to 97·9); 67.2% (95% CI: 50.3 to 78.6).

References 1. World Health Organisation.

Dengue haemorrhagic fever: diagnosis, treatment, prevention and control. 2nd edition. 1997. http://www.who.int/csr/resources/publications/dengue/De nguepublication/en/ (accessed 7 June 2014 2014) 2. WHO Dengue and severe dengue fact sheet # 117 Updated March 2014 Available at http://www.who.int/mediacentre/factsheets/fs117/en/ 3. World Health Organization (WHO). Global strategy for dengue prevention control: 20122020. Available at: http://reliefweb.int/sites/reliefweb.int/file s/resources/9789241504034_eng. pdf. Published 2012. Accessed April 3, 2014 EP News Bureau-Mumbai

Oral octreotide for acromegalymaycapture injectables market from 2015: GlobalData RECENT TRIALS exhibiting the effectiveness of oral octreotide for treating acromegaly may be a cause of concern for injectable somatostatin analogs (SSAs), providing that the drug's makers find a more convenient medication schedule for patients, says an analyst with research and consulting firm GlobalData.

Lakshmi Dharmarajan, analyst, GlobalData, covering cardiovascular and metabolic disorders, states that a number of key opinion leaders interviewed by GlobalData are enthusiastic about the prospects of oral octreotide, following its successful trials.

The ongoing phase III trial has yielded 65 per cent of 151 evaluable patients achieving the primary endpoint of hormonal control, with side effects similar to those of SSAs. Consequently, GlobalData expects oral octreotide to be launched in the major US and European markets by late 2015, with Roche having secured a commercial licensing agreement with drug maker Chiasma Pharma.

Dharmarajan says, “Injectables have been the mainstay of the field for many years, with Novartis’ Sandostatin LAR, the current standard of care, requiring monthly administrations by a healthcare provider.

“There are a few other marketed drugs, such as Ipsen’s Somatuline Depot and Pfizer’s Somavert, which are self-administered injectables.

However, self-administration is not a preferred option for patients, as many do not like injecting themselves with needles.”

While several physicians interviewed by GlobalData believe that oral octreotide might replace injectables if shown to display real world equivalence to SSAs, reservations remain about the drug’s efficacy in aggressive or refractory cases of acromegaly,

EXPRESS PHARMA

29

August 1-15, 2014

and also its frequency of administration.

The analyst explains, “The

greatest obstacle for the oral medication will be the practicalities involved with schedul-

ing doses, as the trial required patients to space their meals a couple of hours before and

after taking the drug.”

Reuters

RESEARCH

Roche’s drug for Alzheimer’s fails main goals Study involving 431 patients found crenezumab failed to significantly slow cognitive and functional decline compared to placebo ROCHE'S EXPERIMENTAL drug crenezumab failed to delay a decline in thinking and memory skills in people with Alzheimer's disease, a result likely to bolster a growing belief that drugs need to be given in earlier stages of the disease to show a benefit. The Swiss drugmaker's treatment was tested in patients with mild-to-moderate forms of Alzheimer’s, a fatal, brain-wasting condition that gradually robs patients of their ability to think and care for themselves.

Results of a phase II study involving 431 patients found crenezumab failed to significantly slow cognitive and functional decline compared to placebo, missing the study's two main goals, Roche said in a statement.

But an exploratory analysis of patients with a milder form of the disease who received a higher dose of crenezumab via an intravenous infusion showed a statistically significant reduction in cognitive decline, Roche said.

Carole Ho, Director of Early Clinical Development, Roche's biotech unit Genentech, said that she was encouraged by the data, even though it missed its main goals, since it demonstrated that treating the disease earlier could increase the benefit. Ho said Roche would decide on any future plans for additional clinical studies following an analysis of the data in conjunction with health authorities.

Analysts had anticipated limited success for crenezumab, after a similar treatment from Pfizer and Johnson & Johnson called bapineuzumab, and solanezumab, a drug from Eli Lilly and Co, failed in late-stage trials. All three drugs work by blocking the toxic protein betaamyloid that forms plaques in the brain believed to signal the

30 EXPRESS PHARMA August 1-15, 2014

GenSpera’s onco prodrug shows promise for patients with advanced HCC 80 per cent patients treated had no tumour growth at two months; 50 per cent exhibited stable disease at four months GENSPERA, A leader in developing prodrug therapeutics for the treatment of cancer, has released the APPLE 2014 presentation. Devalingam Mahalingam, Principal Investigator of the G-202 phase II trial in hepatocellular carcinoma (HCC) patients, recently presented the HCC clinical trial update for G-202 at the 5th

onset of the disease.

Another protein called tau that forms twisted fibres and tangles inside the brain is also considered to be a possible culprit.

The findings add to a string of data suggesting the best hope is testing drugs much earlier in the process before patients' brains are wrecked by Alzheimer's.

Lilly has since started a new clinical trial focusing only on patients with mild signs of the disease. Other trials are already underway testing people who have not yet shown any symptoms of Alzheimer's to try and gauge whether early intervention can prevent or slow the disease.

Crenezumab, which was licensed from Swiss biotech company AC Immune in 2006, is also being tested in a US government-backed trial in a group of Colombians with a genetic mutation that causes them to develop Alzheimer's early. Results of that trial are due in 2020.

A second Alzheimer's drug

from Roche, known as gantenerumab, is also being investigated in a late-stage trial with patients who are yet to develop any signs of the disease.

Roche said a smaller phase II biomarker study also showed an effect of slowing cognitive decline in patients with a milder form of the disease. Details of this study will be presented at the Clinical Trials in Alzheimer's Disease meeting in November.

The drug was well tolerated with only one case of vasogenic edema, a brain swelling side effect seen in similar drugs, allowing crenezumab to be administered at higher doses, Roche said, though patients taking the medicine did have a higher incidence of pneumonia than those on placebo.

At lower doses when crenezumab was administered through an injection beneath the skin no significant benefit was seen even in milder patients, the results revealed.

Reuters

Asia-Pacific Primary Liver Cancer Expert Meeting in Taipei, Taiwan.

Mahalingam, an oncologist at the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio, presented interim results from the phase Ib and ongoing phase II study in hepatocellular carcinoma (HCC) patients who had previously progressed on, or who were intolerant of, sorafenib. Historically, this patient population has a median time to progression of only two months when they enter subsequent clinical trials.

Impressively, 80 per cent of patients treated with G-202 had stable disease (no tumour growth) at two months and 50 per cent of patients exhibited stable disease at four months on study.

"The efficacy and safety

analyses on patients enrolled to date on this study continue to demonstrate that G-202 holds promise for patients with advanced HCC, with half the patients showing disease stability at four months and the majority of patients tolerating G-202 with minimal toxicities," stated Mahalingam.

“DCE-MRI is a sophisticated imaging technique that allows us to assess effects of G202 on tumour blood flow characteristics,” said Dr Craig Dionne, Chief Executive Officer, GenSpera.

Dionne continued, "These positive results enable management to remain optimistic about our ambitious G-202 clinical development programme which is expanding into glioblastoma, prostate cancer and renal cell carcinoma trials. Although still in early stages, we believe this clinical strategy will continue to build significant value in G202 and in the company. We are particularly excited by the potential that G-202 is showing as a treatment for patients with liver cancer, a market which is expected to be at $1.5 billion by 2019.”

EP News Bureau- Mumbai

Mix with the world of pharma, products, people & solutions

2-4 December 2014

Bombay Convention & Exhibition Centre Mumbai, India

Visitor Registration is Now Open Register online now and do business with 32,000 pharma professionals from all over the world @ CPhI & P-MEC India 2014!

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RESEARCH RESEARCH UPDATES

Drug improves birth rates for women with ovary disorder Clomiphene works by blocking estrogen action, which stimulates hormones that induce ovulation POLYCYSTIC OVARY syndrome (PCOS) is a leading cause of female infertility. It affects five to 10 per cent of reproductive-age women. Women with PCOS have unusually high levels of male hormones, infrequent or irregular menstruation cycles, and oftentimes enlarged ovaries packed with fluid-filled cysts.

The current treatment for PCOS infertility is the drug clomiphene. It works by blocking estrogen action, which stimulates hormones that induce ovulation. However, clomiphene has multiple side effects, including hot flashes and mood changes. The drug’s 22 per cent success rate for live births is

relatively low, and it tends to lead to a high number of twin or multiple pregnancies.

In a search for more effective ways to reverse PCOS infertility, some physicians have begun using the drug letrozole.

Letrozol has been approved as a breast cancer treatment by the US Food and Drug Administration. The drug is also known to suppress production of estrogen, which in turn triggers release of the hormones that drive ovulation.

A multicentre clinical study led by Dr Richard S Legro of Penn State College of Medicine compared the effectiveness of letrozole and clomiphene in treating PCOS-related infertil-

ity. The effort was funded in part by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Centre for Advancing Translational Sciences (NCATS). Re-

sults were published recently in the New England Journal of Medicine.

The researchers enrolled 750 infertile women with PCOS who were between 18 and 40 years of age. All participants

were attempting to achieve pregnancy, and their male partners met minimum sperm count requirements. The participants were randomly divided into two groups to receive either letrozole or clomiphene.

Women were given up to five monthly cycle treatments.

The researchers found that women treated with letrozole were more likely to have live births than those receiving clomiphene (27.5 per cent vs.

19.1 per cent). Letrozole also led to significantly increased ovulation rates compared to clomiphene (61.7 per cent vs.

48.3 per cent).

EP News Bureau-Mumbai

Gene changes identified in lung cancer By analysing DNA, RNA, and protein levels, the team determined that several metabolic pathways were activated in the tumour samples LUNG CANCER is the most common cause of cancer deaths in the US and throughout the world. Like all cancers, lung adenocarcinoma arises from errors in DNA that lead to uncontrolled cell growth. Identifying the changes in each cancer’s complete set of DNA, its genome, may ultimately result in more targeted therapies, improved prevention, and new detection strategies.

The Cancer Genome Atlas (TCGA) Research Network is a comprehensive effort to analyse the molecular basis of cancer.

With more than 150 scientists at

32 EXPRESS PHARMA August 1-15, 2014

dozens of institutions across the nation, the TCGA research network is funded by NIH’s National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI). In a new TCGA study, researchers examined tumour samples and matched normal material from 230 patients with lung adenocarcinoma. The study recently appeared online in Nature.

In 143 out of 230 samples (62 per cent), the researchers found known activating mutations (misspellings) in oncogenes, genes known to have the potential to cause cancer when mu-

tated or expressed at high level.

To identify additional alterations, the investigators looked at DNA copy number changes, changes in gene number from the deletion or multiplication (amplification) of sections of DNA. They detected amplification of two oncogenes, ERBB2 and MET, that are part of a signaling pathway known as RTK/RAS/RAF. These mutations cause the pathway to become stuck in the “on” state, triggering tumour cell growth and survival.

The researchers also identified mutations in other genes, in-

cluding NF1 and RIT1, part of the RTK/RAS/RAF pathway, that can drive lung adenocarcinomas.

By analysing DNA, RNA, and protein levels, the team determined that several metabolic pathways were activated in the tumour samples. Overall, 76 per cent of the samples had mutations that activate the RTK/RAS/RAF pathway. This work may lead to refinements in how cancers are classified and could lead to more personalised diagnosis and treatment.

EP News Bureau-Mumbai

RESEARCH

Asthma drugs suppress child growth Steroid-containing inhalers are prescribed as first-line treatments for adults and children with persistent asthma CORTICOSTEROID DRUGS given via inhalers to children with asthma may suppress their growth, according to two systematic reviews of scientific studies on the issue. Health experts who conducted the review and published it in The Cochrane Library journal found that children's growth slowed in the first year of treatment, although the effects were minimised by using lower doses.

Steroid-containing inhalers are prescribed as first-line treatments for adults and children with persistent asthma.

They are the most effective asthma control drugs and have been shown to reduce asthma deaths, hospital visits and improve quality of life by cutting the number and severity of attacks. Yet their potential effect on children's growth is a source of worry for parents and doctors - a factor which prompted the Cochrane reviewers to analyse the evidence more closely.

"The evidence suggests that children treated daily with inhaled corticosteroids may grow approximately half a centimetre less during the first year of treatment," said Linjie Zhang at the Federal University of Rio Grande in Brazil, who led the review. "But this effect is less pronounced in subsequent years, is not cumulative, and seems minor compared to the known benefits of the drugs for controlling asthma."

According to data from the World Health Organization (WHO), some 235 million people worldwide suffer from asthma, a chronic disease which inflames and narrows the air passages of the lungs. The disease is common among children.

The first of the two systematic reviews focused on 25 trials involving 8,471 children up to 18 years old with mild to moderate persistent asthma. These trials tested almost all the available inhaled corticosteroids and showed they sup-

pressed growth rates when compared to placebos or non-steroidal drugs.

Fourteen of the trials reported growth over a year and found the average growth rate, which was around six to nine centimetres (2.4 to 3.5 inches)per year in control groups, was about 0.5 cm (0.2 inch) less in the groups of children being treated with inhaled steroids for asthma.

In the second review, researchers looked at data from 22 trials in which children were treated with low or medium doses of inhaled corticosteroids.

Only three trials followed 728 children for a year or more and the reviewers said they showed that using lower doses of inhaled corticosteroids, by about one puff per day, improved growth by around a quarter of a centimeter (0.1 inch) at one year.

Francine Ducharme of the University of Montreal in Canada, who worked on both reviews, said the findings were important and should prompt more frequent and detailed tracking of childhood asthma patients' growth. "Only 14 per cent of the trials we looked at monitored growth in a systematic way for over a year," she said. "This is a matter of major concern given the importance of this topic."

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Reuters

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August 1-15, 2014

PHARMA ALLY

THE DATADELUGE

There has been a lot of discussion around the potential of big data in pharma and how it could be a game changer in bringing new paradigms to drug discovery, clinical trials and other such areas of the pharmaceutical value chain. By Shalini Gupta

P

harmaceutical companies manage vast amounts of information regarding products, customers, prescriber behaviour and clinical trials across hundreds of different types of compounds. However, they are also careful about sharing this information openly, given the risk and uncertainty coupled with getting a blockbuster drug to market.

Realising the importance of big data and utilising it sufficiently would be crucial and perhaps the only way forward to getting more value out of it, if experts are to be believed.

Data with benefits As in sales and marketing, Big Data analytics can be used to manage and analyse data generated with respect to drug formulations, chemical compounds for drugs, details of clinical trials, etc. C Gowri Shankar, Executive Director, TAKE Solutions suggests that rather than creating “value from the volume of data” that is present, it would be better to create insight from it.

Rising R&D costs, lower success rates in the development of new molecules, high expectations from healthcare providers and end customers, shift from single molecule or formulation for the entire population to specific formulations for patients with specific genetic disposition calls for new innovation in drug research. Add to this the rise in the average cost per NME (new molecular entity) or biologic from $2.8 billion (2002 – 06) to $4.8 billion(2007-11).

“A newer approach to drug

34 EXPRESS PHARMA August 1-15, 2014

discovery would require an insight into understanding the efficacy of existing molecules and formulations across different demographic groups and patient types. Big data analysis and insight from hospital patient records (EPRs / EMRs) could go a long way in providing the necessary insights and knowledge,” Shankar echoes. This would serve as the starting point for drug development for existing diseases, combination formulations and presently incurable diseases he adds.

This is further aided by the short time cycles for genome sequencing and drastic reduction in the cost of such sequencing. While in 2001 it cost $95 million to read an entire human genome, two leading manufacturers are developing machines that can do so for as little as $1000, in a matter of hours. Big data analysis of all historical discovery initiatives would be a starting point to improve the efficiency of the R&D process. This is likely to be a potential starting point for accelerating development

and using old research for newer applications.

Pharma companies are also battling claims as a result of adverse reactions to drugs, post launch. Tracking of adverse events is typically done by a report by the patient to the doctor who then decides after an evaluation if this qualifies as an adverse event to be reported to the company. Multiple formulations that each patient is subjected to, the maturity of the process in each geography, under reporting, lack of patient aware-

ness and ease of access to the doctor further complicate the process. Corrective action is thus liable to be delayed and the scope for minimising the impact of true adverse events on the entire patient population is weak.

However, regulatory changes make it important for companies to take note of adverse events even as social media offers a platform for patients to report such adverse reaction. “Big data analysis for adverse event tracking in the social media could be very

“A newer approach to drug discovery would require an insight into understanding the efficacy of existing molecules and formulations across different demographic groups and patient types. Big data analysis and insight from hospital patient records (EPRs / EMRs) could go a long way in providing the necessary insights and knowledge”

“Starting from patient profiling by identifying the right candidates through analytics of demographic information and historical data, evaluating drug readiness, reviewing previous clinical trial events, intervention through correct drug dosage to remote patient monitoring, big data can help bring innovation and build competitive advantage through the clinical trial process”

C Gowri Shankar,

Somenath Nag,

Executive Director, TAKE Solutions

Director, ISV & Enterprise Solutions, ALTEN Calsoft Labs

beneficial to the pharma industry and help provide a heads up before the formal signal detection through the existing systems kick in,” opines Shankar.

Somenath Nag, Director, ISV & Enterprise Solutions, ALTEN Calsoft Labs feels that companies can get maximum RoI by using Big data analytics to analyse clinical trial data and genome sequencing data. “Starting from patient profiling by identifying the right candidates through analytics of demographic information and historical data, evaluating drug readiness, reviewing previous clinical trial events, intervention through correct drug dosage to remote patient monitoring, big data can help bring innovation and build competitive advantage through the clinical trial process,” he pitches in.

It could also help perform computations of large-scale genomics in a timely and costeffective manner given that processing of sequence data using traditional BI and data management platforms remains a significant challenge.

Tapping the unknown However, even as the opportunity remains largely un-

tapped, Shankar puts it best when he orchestrates why companies are gingerly in realising the big data opportunity. “The biggest challenge in implementation of big data projects is that 'we do not know what we do not know'.

Companies are wary of investing till they see proof of concepts of possible insights from big data analysis,” he says.

The absence of relevant technologies to analyse unstructured data, cost of computing power, lack of viable technology alternatives, and reluctance to reveal confidential data pose other problems.

The biggest challenge in big data projects, however, is getting multiple stake holders with tangential objectives to work together especially when they need to commit themselves to resources without an accurate sense of the outcome. These include the sponsor who stands to benefit from the outcome, the owners of the raw and unstructured data, the technology experts, the domain experts and service providers. Innovative models for compensation and monetisation for all stake holders are important in the light of unpredictable outcomes, he adds.

Nag strongly feels that an

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The biggest challenge in big data projects, however, is getting multiple stake holders with tangential objectives to work together especially when they need to commit themselves to resources without an accurate sense of the outcome integrated data-centric approach with a clear owner for each data type across functional silos and through the data life cycle is required for a

successful adoption of Big Data initiatives, given that most companies work in silos.

A successful Big Data initiative with an increased ability to share data requires rationalising and connecting systems which typically contain heterogeneous and disparate data. Enterprises also have shortage of people capable of developing the technology and analytics platform needed to extract maximum value from the existing data, he adds.

GSK has been at the forefront of the big data revolution and along with Bayer, Sanofi, Roche, and Lilly, have collaborated to upload patient-level data collected by clinical trials to a web portal(clinicalstudydatarequest.com), where researchers can submit proposals and request anonymised data from certain studies. Collaborations like those between Optum and the Mayo Clinic where Optum provides analytics tools and data to allow researchers to explore information on 149 million UnitedHealth Group patients, while Mayo contributes clinical data on around five million patients to facilitate research is another model.

Thomson Reuters recently

announced the availability of data on more than 180,000 clinical trials through its Cortellis Clinical Trials Intelligence programme, including data on drugs, biologics, biomarkers, diagnostics, and medical devices. The data can be accessed through analytics tools within the Cortellis platform or through an API embedded in other software applications, widening the possibilities for clinical integration and research substantially.

The solution will allow users to discover competitor strategies for specific patient segments, biomarker utilisation, end points and novel insights into disease processes and to uncover vital connections by integrating their internal, proprietary data with the wide variety of reference information available through Cortellis. These are early days for big data in pharma, however, newer models are emerging, and it is likely that as the benefits accumulate and reveal themselves, other stakeholders will follow suit.

Ultimately businesses will have to realise the hidden or latent value of all the data lying inert with them. shalini.g@expressindia.com

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‘IT’IS SAFE

Growing emphasis on safety has led to an increasing dependence on IT amongst pharma players. However, the challenges are set to multiply as growth in pharma innovations would make safety much more imperative than ever before. By Sachin Jagdale

O

ver the years Information Technology (IT) has had considerable impact on the way different industries function. Pharma industry is perhaps the biggest beneficiary of this revolution, as introduction of IT has made operations in the pharma industry more reliable. However, safety is arguably the most important contribution of IT to pharma operations. No wonder, pharma companies are heavily relying on IT solutions for all their safety related needs.

Take ‘IT’ safely Taking medicines safely to the final consumer is perhaps more challenging than manufacturing them. IT comes to rescue here as well and helps in securing the passage of medicines up to its final consumer.

“Presently all machines, systems and processes are governed by IT solutions to maintain cGMP. In the US, epedigree, RFID-based drugauthentication are used to protect against counterfeit, subpotent, substandard, misbranded or expired products,” informs Nitin Borkar, Chief Executive Officer, Vergo Pharmaceuticals.

A company can have its own IT safety measures or it can outsource the same.

Vergo Pharmaceuticals is a CRO which handles a considerable amount of sensitive data. Borkar says, “The contract research organisations handle multiple clients with utmost confidentiality. We have an in-house IT security

36 EXPRESS PHARMA August 1-15, 2014

infrastructure to protect our data.”

However, a company like Raptakos Brett and Co has an advanced IT security set up but they also seek additional assistance from a specialist IT company. Rajesh Rane, Senior Vice President, IT, Raptakos Brett and Co says, “We have a combination of both 60:40, major decisions and controls

are taken in-house and additional support whenever required is taken from outsourced IT company.”

Oracle is an IT firm with global footprints and is renowned for its innovative offerings for the life sciences industry as well. Niraj Kaushik, Vice President, Applications, Oracle India, talks about uses of IT in preventing

possible intrusion in the pharma supply chain. He says, “International trade in counterfeit medicines is rapidly increasing, presenting serious risks to public health around the world. To ensure patient safety, pharma manufacturers urgently need to find ways to protect the integrity of their own products and keep counterfeit medicines out of the le-

gitimate supply chain.”

He adds, “IT can play a major role in this serialisation and pedigree management easily and at a low cost. Technology can enable pharma companies to combat the threat posed by counterfeit medicines today while creating a solid technological infrastructure for compliance with the likely regulatory requirements of

PHARMA ALLY

The IT system gives a unmistakable identity and location, computations and repetitive tasks are precise, human speed is no match to computer speed, unattended monitoring and recording for customer confidence gives security which can be verified

To ensure patient safety, pharma manufacturers urgently need to find ways to protect the integrity of their own products and keep counterfeit medicines out of the legitimate supply chain. IT can play a major role in serialisation and pedigree management easily and at a low cost

Nitin Borkar,

Vice President, Applications, Oracle India

Niraj Kaushik,

Chief Executive Officer, Vergo Pharmaceuticals

tomorrow. To support pharma companies in their efforts to introduce electronic pedigree and serialisation capabilities into their manufacturing and supply chain operations, Oracle has developed a dedicated software application: Oracle Pedigree and Serialization Manager (OPSM). Supported

by Oracle’s capabilities in data management, availability, performance, scalability and security, OPSM is the fastest and most cost-effective solution to combating the threat posed by counterfeit medicines, now and into the future.”

Reiterating Kaushik’s views, Rane says, “IT is helping in the distribution setup to achieve higher service levels, lower inventory and lower supply chain costs. IT contributions and implementations are discussed based on changes that have occurred in today’s economy which ultimately can result in better support to the end consumer.

Each and every product batch is tracked from production to the stockist.”

Technology ‘can’ what human ‘can’t’ Elbert Hubbard, an American writer, had once said that, “One machine can do the work of fifty ordinary men.”

Pharma industry understood the limitations of human intervention in safeguarding pharma products and this led to growing use of IT in this sector.

Kaushik says, “The sheer

Till now IT sector has developed satisfactory solutions for the safety needs of the pharma companies, however, the job is not done yet. With patent expiry and growing emphasis on biologics, coming years would be more challenging and complex for both, the pharma industry and the IT solution providers volume of information and speed at which it is being generated makes it impossible for humans to process it, and naturally securing that amount of information would clearly be out of question. Moreover, it is not humanly possible to keep a tab on the supply chain of medicines and track counterfeit ones. Without the deployment of technology solutions there is a high risk factor involved.”

Speaking about how extensively IT has replaced human intervention at his company, Rane informs, “Latest technologies are in place at all our plants. We have implemented Enterprise Resource Planning (ERP) solutions and modules like QC/QA, maintenance and production. Every transaction is being tracked through the modules and various Management Information System (MIS) reports required by the users are generated. Access controls, CCTV and visitors management systems are in place at the plant locations.”

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“The IT system gives an unmistakable identity and location, computations and repetitive tasks are precise, human speed is no match to computer speed, unattended monitoring and recording for customer confidence gives security which can be verified,” opines Borkar.

All said and done, no machine can completely replace human intervention. On the contrary, technology helps to optimise human efforts.

Hurdles to overcome Though IT takes the driver’s seat as far as security measures are concerned, there are some areas where it hasn’t helped the pharma industry.

Borkar explains, “Some critical areas where IT solutions for safety needs to be developed are compliance of systems, storage of chemicals and test articles and integration of all video, audio and tracking system to develop authentic documentation.”

Pharma is a continuously

evolving sector where innovation is key for survival. Hence IT technologies also need to transform constantly to meet the changing safety-related demands of the pharma sector.

Kaushik says, “Today, the pharma industry is dealing with one of the most serious challenges affecting the integrity of the supply chain; i.e. counterfeit medicines. As awareness of this issue grows among healthcare providers and patients, there is increasing pressure on the industry to put measures in place to protect patients from unscrupulous criminals who are responsible for this menace to public health.”

According to Kaushik, given the obvious threat to public health, patient safety remains the number one driver for increasing vigilance against counterfeit medicines.

However, there are also significant business benefits to be gained from securing the supply chain against counterfeit products through IT

solutions, including reducing reimbursement fraud against healthcare payers, protecting brand integrity, and gaining better insight into parallel trade activity.

While Kaushik’s main thrust is on supply chain related challenges, Borkar narrates some of the safety related challenges that may crop up within the plant. “Affordable integration of data systems with Laboratory Information Management Sustem (LIMS), ERP and Electronic Library Network (ELN) is going to be the key requirement of the pharma sector. Pharmacy informatics and computerised physician order entry are also crucial from the safety point of view where IT will have to offer effective solutions,” says Borkar.

Pharma industry’s dependance on IT for its safety related requirements is going to grow in future. Hence, the industry keeps exploring new ways of manufacturing effective medicines and this adds to complexities of day-to-day operations. Till now IT sector has developed satisfactory solutions for the safety needs of the pharma companies, however, the job is not done yet.

With patent expiry and growing emphasis on biologics, coming years would be more challenging and complex for both, the pharma industry and the IT solution providers. sachin.jagdale@expressindia.com

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Moving towards an

E-DOCUMENTCULTURE The clinical trials industry feels that implementation of digitisation initiatives and e-governance measures can only help bring better transparency to the approval system. But some companies are still resisting the move towards an edocument culture. By Usha Sharma

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PHARMA ALLY

“CROs should definitely encourage an e-document culture. edocuments help in ensuring uniformity of process and standards, ease of use and lower costs” Anita Tripathy, President, India, inVentiv international Pharma Services

I

nformation technology (IT) is playing an important role in today’s fast paced world influencing every facet of our daily lives.

And its influence is only set to increase with Prime Minister Modi’s success with the e-governance model in Gujarat set to be scaled up at the national level.

Health Minister Harsha Vardhan too has promised transparency and e-governance measures to bring more accountability in all governmentcitizen interfaces.

The thrust on transparency and accountability is welcomed by the clinical trials sector, which has been protesting the lack of it in the approval process. The sector has witnessed various regulatory reforms in the past one and half years which has led to a slow down in approval of clinical trials.

This could change if the clinical trial approval system goes online. Recalling recent developments connected to CDSCO and Drug Controller General (India) (DCG(I)) statement Hemant Rehani, Vice President and Head CDS, Quintiles states, “We have seen recent media reports that the DCG(I) intends to introduce e-governance for clinical trial approvals which is very encouraging.”

The intention is good but would mean high levels of digitisation within industry. As Rehani points out, “Besides the regulators, an IT-enabled environment has to be created across the entire clinical research ecosystem, most notably sites. Hospitals and medical institutions also need to invest in technology-enabled solutions particularly in maintaining

“An e-document culture will provide real-time access to critical information that will enable business analytics to take actions in a proactive manner, thereby improving quality, data integrity and patient safety” Hemant Rehani, Vice President and Head CDS, Quintiles

health records.”

Is the industry ready? Creating and maintaining such an ITenable environment has many benefits. Given the volume and sensitivity of the data involved in clinical research, the ability to maintain data integrity and quality is a prime consideration.

Inter-operability of systems and standards is also important as clinical research deals with data coming in from different sources, across different platforms and geographies. Rehani briefs, “The most important aspect is that technology needs to help, improve patient safety and outcomes, and deliver therapeutic benefits that are cost effective, faster and more efficacious.”

Tech savvy approach The pharma sector is among the most highly regulated sectors, with documentation mandatory to at every step of the regulatory process. Giving an example, Nimita Limaye, Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services highlights, “Audit trails are critical in a highly regulated industry such as the pharma industry. Electronic trial master files (eTMFs) provide real-time and secure access to clinical documentation to sites across the globe through the entire lifecycle of the trial. This allows for seamless collaboration, higher levels of compliance and documentation quality facilitating auditor review and submission readiness of documents, in alignment with the DIA’s TMF Reference Model.”

Apurva Shah, Group Managing Director, Veeda CRO opines, “A good Data Management Sys-

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tem (DMS) should have uncompromised regulatory compliance. Therefore the benefits would be far reaching for any CRO in terms of security, accountability and tractability of data. This would help during sponsor and regulatory audits.

It would be a very good way of showcasing the quality of systems and processes.”

Regulatory authorities like US FDA and UK MHRA have initiated and begun to accept esignatures for better transparency in the approval process.

Commenting on the e-signature move, Anita Tripathy, President, India, inVentiv international Pharma Services says, “CROs should definitely encourage an e-document culture. edocuments help in ensuring uniformity of process and standards, ease of use and lower costs.”

Underlining the significance

of e-signature culture in CRO industry, Rehani says, “An e-document culture will provide real-time access to critical information that will enable business analytics to take actions in a proactive manner, thereby improving quality, data integrity and patient safety. It will not just provide transparency and accountability but it will also help in streamlining the clinical trial approval process and eliminating the need for intermediaries.”

Lack of awareness The biopharma industry is quite sophisticated and advanced in its adoption of technology at manufacturing sites. But the challenge is at the regulatory end as they are still not geared up to support complete digitisation.

Regulators in India are well

“I think it is absolutely essential to encourage an edocument culture. It drives efficiency, security and traceability” Nimita Limaye, Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services

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aware of the benefits of going digital and the advancements in e-documentation that their global counterparts have made. Therefore industry observers hope it will not be long before they invest in and adopt technology to make the clinical research process more efficient.

Currently CROs and pharma companies in India are caught between regulators with different levels of digitisation. Dr Renu Razdan, Vice Chairman, ACRO India points out, “Since all regulatory agencies are not equipped to handle electronic data, running the process of e-submission and paper submission in parallel is not a cost effective and efficient option.” She continues, “If we move completely to next generation technologies for edocumentation and e-submissions, it will be easy and beneficial for all organisations. It will also help in standardising the process of submission to regulatory authorities.”

Bringing in a paperless culture There is still a lot of uncertainty in the industry around using eTMFs. While a paperless environment is desirable, companies are taking a conservative approach towards eTMF implementation. As Shah highlights, “Using eTMF is a culture change; we need to be internally ready with processes to be able to switch to eTMFs.” If the result is beneficial in both the short as well as long term, why are companies still hesitant to switch to the new processes? Shah probably reflects many of his peers when he replies, “We need to assess the readiness of the existing IT infrastructure. The element of reluctance comes mainly from the challenges involved in migration to new technologies and which could in turn lead to technical risks, unpredictable costs, scheduling concerns and skills and culture issues.”

There seems to be general consensus that the complex nature of the industry adds another dimension to such decisions. Explaining this slower

40 EXPRESS PHARMA August 1-15, 2014

Industry observers hope it will not be long before they invest in and adopt technology to make the clinical research process more efficient than desired pace of change, Rehani says, “As an industry we are traditionally risk-averse and moderate risk takers. This is primarily due to the highly regulated environment we operate in, which is justifiable due to issues like patient safety and confidentiality. Therefore there is a guarded approach to adopting next generation technologies.”

Size also plays a crucial role in such decisions. As Tripathy says, “Smaller firms have concerns over the costs of implementing a high end technology enabled solution. The second stumbling block is usually the lack of in-house expertise.

However, these concerns can be alleviated by moving forward with an experienced partner with a proven track record and with an available IT infrastructure. These technologies can reduce the cost, improve the cycle times significantly and increase the ease of use.”

The paper vs electronic debate Indian CROs use both paper and electronic documentation which is mainly driven by regulatory requirements. The industry feels that implementation of digitisation initiatives with e-governance measures can only help bring better transparency to the system.

Rehani analyses, “We need a strong e-governance structure within the regulatory structure to facilitate and enable an edocument culture. For historical reasons, the inclination of the Indian regulators towards paper-based communication is high. CROs have trusted paperbased communication with the regulators although the preference is to go electronic.”

“Indian CROs prefer using electronic data for accuracy

and reliability. However, Indian regulatory bodies prefer data in hard copy format,” informs Shah.

A few big CROs/pharma companies like Pfizer, Novartis and Boehringer Ingelheim, etc. have switched to and adopted efficient IT enabled technologies (ie; eTMF) across their global operations. But across the industry, there is still huge scope to adopt these technologies to streamline the processes.

Limaye strongly says, “I think it is absolutely essential to encourage an e-document culture. It drives efficiency, security and traceability.” According to her, the solution needs to be evaluated on parameters like whether it is effectively auditable. user friendly. Costs, integration with existing systems, regulatory compliance, data security, training and help desk support, set up time, scalability, data security, archiving options, flexibility to upgrade based on regulatory changes, etc are other considerations, she adds.

Risks vs benefits Opportunities and challenges are integral aspects of growth.

Certainly IT implementation in across the clinical trials sector will enhance capabilities, but companies will have to deal with concerns like the cost of implementation and skilled manpower, which seem to be the main challenges while adopting IT-enabled solutions.

Attitudes are changing, but slowly. Commenting on this aspect, Renu predicts, “Indian CROs are now transforming to e-submission and documentation wherever accepted. However, there is a long way to shift to e-submission and documentation which requires adapta-

tion of new technologies and trained manpower.”

But solutions also exist. Limaye suggests, “Typical challenges involve in creating IT enabled environment; awareness, investment, change management and rapidly evolving regulations. A private cloud with a multi-tenant architecture enables pharma companies to keep up with frequent upgrades, enhancements and regulatory changes in a cost effective manner.”

“Any CRO is at the mercy of what a sponsor’s auditor is asking for. It is mainly about getting beyond the paper culture. Although the FDA and other regulatory agencies have defined the requirements for electronic document and record systems that store clinical trial essential documents, no government agency has defined how eTMF content should be classified, or the standards for meta data that may used in content indexing, or the electronic format(s) that should be used to model, store or exchange eTMF data.

As a result of the lack of a standard to represent eTMF content, eTMF information interoperability and content exchange between systems and applications is inefficient,” shares Shah.

It is important for companies to evaluate their financial resources, ability to orchestrate change and in-house technical expertise. There are costs and efforts associated with changing internal business processes, on-going training for internal resources to keep them updated on new specifications and standards and maintenance and support of the technology. This helps in mitigating the risks to a great extent. The bottom line is that while it does cost to go digital, not doing so may turn out to be more costly in the long run.

“For instance, 25 per cent of RTF (refusal to file) from FDA is due to wrong eCTDs. It is important to appropriately train resources on usage of next generation technologies,” sums up Tripathy. u.sharma@expressindia.com

“A good Data Management System (DMS) should have uncompromised regulatory compliance.

Therefore the benefits would be far reaching for any CRO in terms of security, accountability and tractability of data” Apurva Shah, Group Managing Director, Veeda CRO

“Since all regulatory agencies are not equipped to handle electronic data, running the process of e-submission and paper submission in parallel is not a cost effective and efficient option” Dr Renu Razdan, Vice Chairman, ACRO India

PHARMA ALLY CIO SPEAK

Sanofi India: Moving beyond automation

IT: KEYTO PROGRESS The pharmaceutical industry may have lagged other sectors when it comes to IT implementation but early adopters are today reaping the rewards.

Express Pharma gets three CIOs to dissect their IT strategies

Lupin: On the cloud train LUPIN HAS kept pace with the advancements in IT and taken efforts to incorporate it in the company. Among the firsts is its emphasis on the integration of cloud within the company, and it goes without mention that it has been amongst the early adopters of cloud-based computing and storage.

Proactive steps The entire workforce of 14,500 moved to cloud-based email in 2012. The sales force automation system catering to its 6000strong field force as well as security solutions such as Internet content filtering, anti-virus systems are also cloud-based. This year they implemented a cloudbased Performance Management System by Success Factors (A SAP Company). Pitches in Mayur Danait, Chief Information Officer, Lupin, “Broadly, when we evaluate a new system or technology, we look at the cloud option first – we host it onpremise only if the cloud is not feasible. The objectives have been reducing our in-house IT infra footprint, harmonisation, rapid deployment and higher service levels, something we have achieved with each of the above initiatives.”

This is reflected in a

MAYUR DANAIT Chief Information Officer, Lupin

proportionate increase in investment allocations to IT along with company growth. In the past few years, the focus has been towards globalising ERP and supply chain systems, manufacturing and quality systems, revamping infrastructure, IT security. Going forward, the shift will be towards mobility and analytics. IT has enabled significant acceleration of processes on the supply chain side by making data and decision-support systems available to the key functionaries.

Towards efficiency and cost advantage Cloud initiatives on the messaging and collaboration front have saved 15-20 per cent of costs to the company annually. Produc-

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tivity initiatives on the sales force side have resulted in 50 per cent annual savings by eliminating paperwork, and manual data aggregation. This means that the average sales representative has more time to visit doctors, chemists and distributors by cutting down on time previously spent on administrative work.

The focus is to invest in systems on the R&D side – including managing laboratory information, clinical operations and data etc. Danait feels that automation could serve twin benefits of process acceleration, transparency and statutory and regulatory compliance if applied to certain areas within the organisation. He says that pharma companies still lag behind their domestic FMCG counterparts and their global industry peers when it comes to incorporation of information technology. However, emergence of new technologies allows companies to leapfrog to the next level. He concludes, “So long as we get our priorities right we will continue to narrow the gap. Pharma companies do realise the impact of technology on areas like sales force productivity, supply chain efficiency and compliance, reporting and analytics etc. and are ready to move to the next level.”

SANOFI INDIA'S major thrust areas for IT implementation are manufacturing, sales and marketing, HR and finance. To support these business areas, the technology focus is on Business Process Management (BPM), mobility (internal and external) and analytics, according to Milind Khamkar, Sr. Director Information Solutions - India & South Asia, Sanofi India After the adopting and promoting the automation of business processes with right workflow strategies, the company stabilised major transactional systems like ERP, SFA, Planning, etc but it was observed that there were many processes connected to these major systems which were efficiency killers as well as causing delays in the decision making process.

With the strong sponsorship of the CFO, Khamkar relates that they have launched an initiative towards the simplification and harmonisation of business processes using workflow tools.

As a part of these initiatives they identified as many as 50+ processes which could be automated for agility, redundancy control, process controls and compliance, expediting decision making and enhancing customer services.

According to Khamkar, “We are progressing well on adopting analytical tool across sales and marketing.

We are supporting BYOD, helping our specific field force with iPAD for eDETAILING and daily call reporting, launching customer facing mobile applications etc. Our BPM journey is progressing well.” For this year, the IT team is busy integrating state of the art technology in the new headquarters in Mumbai.

MILIND KHAMKAR Sr Director Information Solutions - India & South Asia, Sanofi India

Building long-term differentiators Spelling out the vision behind IT strategies, he says, “Apart from the generic 'Better ~ Faster ~ Cheaper' in automation, IT is helping business enable with innovation, engage with automation and empower with technology.

This will help the business to bundle value added services with the product, increase market reach and improve quality of services to customers.” These will prove to be the differentiators in the long run.

Looking ahead he says, “Unfortunately, the pharma industry has not yet utilised IT to its greater strength.”

He explains that in many companies, IT is still the enabler of functions, taking care of operations or more crudely orders from others.

He has personally been involved with and seen the evolution of many IT implementation initiatives within the pharma industry and therefore has first hand experience of the many business problems which can be tackled by technology. But he rues the fact that there is no common IT forum for pharma. Signing off he says, “Some of us have got together in an informal way to address this vacuum but this initiative will definitely need support and recognition from across the business.”

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ACG Worldwide: Connecting shop floor to top floor ACG WORLDWIDE has carved a niche for itself in the global packaging market and is expanding its presence. The deployment of IT and other related technologies in general has helped the company to accelerate its operations and become much more efficient.

With the help of IT it has significantly improved productivity and aided to increase accuracy, improve quality, and eliminate the challenges that were earlier involved in the process.

There are many new IT initiatives that the company has initiated across ACG. Sharing some details, Vilas Pujari, VP Corporate IT, ACG Worldwide says, “At present, we are implementing CRM, SRM, and bar code for the automation of processes, of which, CRM is on

the cloud. These projects have been initiated in Q4 FY 13-14.

The primary objective of these projects was to bridge the gap between the enterprise and partners, and enable seamless business transactions.”

In today's environment, IT is used in each and every department - be it R&D, sales and marketing, supply chain or manufacturing. Throughout ACG’s offices across the world, the company has deployed IT extensively in the area of manufacturing and R&D, and is continuously working to increase usage of IT in sales and marketing, and supply chain as well.

The company's geographical presence reflects its wide network and to maintain constant growth, it has invested

higher for new applications and hardware consolidation/upgrades. It will continue to increase as adoption improves and the fruits of IT are realised by users.”

Increasing the connect

VILAS PUJARI VP - Corporate IT, ACG Worldwide

considerable amounts regularly. Informing about the company's investment on building a strong IT network Pujari says, “We’ve increased the allocation of capex and opex for IT. Typically, the allocation is

With the help of IT, manufacturing companies have an opportunity to get connected real-time both within the company and with their networks.

“Speaking as an inherent manufacturing company, I believe technology should be taken closer to the shop floor. The connect between shop floor and top floor needs to be established and utilised for achieving greater results. IT can also be used to connect people using

video conferencing, web conferencing, webcasting, webinars, etc., to achieve better collaboration and learning,” mentions Pujari.

Pharma companies have always been at the forefront of deploying technologies and are early adopters of new technologies as well. This helps them in complying with regulatory requirements, improving process control and traceability. This, in turn, enables pharma companies to be transparent and open to audits. In addition, as pharma companies adopt technologies such as track and trace, the role of IT would widen to support end-to-end traceability and ensure consumer welfare, feels Pujari.

(With inputs from Usha Sharma and Shalini Gupta)

I N T E R V I E W

‘Thermonet is a unique product specific to DHL Global Forwarding’ Samar Nath, Chief Executive Officer, DHL Global Forwarding India, in an interview with Sachin Jagdale, reveals more about the company's product How is the response of Indian life sciences and healthcare industry to Thermonet network?

The response to the Thermonet product from customers, during the roll-out sessions, was very encouraging and we are in the process of onboarding customers on select lanes.

Have you made any India specific modifications in Thermonet network?

In India, due to the present infrastructure, we operate these activities within the custodian’s facilities. They support the storage of pharmaceuticals and vaccines

42 EXPRESS PHARMA August 1-15, 2014

and offer customers temperature monitoring, dry ice replenishing along with active and non-active container handling to ensure product quality at all times Do you plan to cover more cities under Thermonet network in India? What services do you offer in Mumbai, Hyderabad and Bengaluru centres?

Yes, there are plans to expand in Delhi, Ahmedabad and Chennai shortly. DHL Thermonet provides seamless temperature visibility along the supply chain, 24/7 proactive monitoring and intervention based on predetermined touch points and

LifeTrack IT platform that also houses all productspecific SOPs, facilitating early intervention and simplifying document control.

Which other countries are already part of this innovative concept?

Overall Thermonet is present in 46 countries globally, primarily in the Americas and EMEA (Europe, Middle East, Africa) regions.

DHL’s RFID Smart Sensor technology, that is also GDP certified. Temperature data and logistics events can be accessed via the proprietary

Who are your competitors?

Thermonet is a unique product specific to DHL Global Forwarding. Our customers in the life sciences

and healthcare sector are looking for better ways to manage the risk of product damage and loss from temperature deviations in increasingly long and diverse supply chains globally. With DHL Thermonet we are defining the new standard to tackle these requirements.

What will be the challenges in making Thermonet network successful in India?

Our key challenges will be in areas where DHL does not have direct control/ access to the cargo, for eg. customs zones. sachin.jagdale@expressindia.com

PHARMA ALLY VENDOR NEWS

WACKER opens logistics centre near Kolkata The high-bay warehouse has a capacity of 5000 pallet spaces and will be operated by WMC MUNICH-BASED chemical group WACKER has opened a new logistics facility at its production site in Amtala near Kolkata. The high-bay warehouse has a capacity of 5000 pallet spaces and will be operated

by Wacker Metroark Chemicals (WMC), a joint venture between WACKER and Kolkata-based Metroark. The new logistics centre compliments WMC’s existing network of warehouses strategically located in Mumbai, Delhi, Chennai and Kolkata.

At the opening ceremony, attended by Levi Cottington, Executive Director, WMC and Soumitra Mukherjee, Managing Director, WMC, Dr Christian Hartel, President, WACKER’s silicones business division, said the new facility will help maximise flexibilty of logistics, increase delivery speed, and minimise lead times for customers.

“This investment will

(L-R) Levi Cottington, Wacker Metroark Chemicals Executive Director, Dr Christian Hartel, President, Wacker Silicones and Soumitra Mukherjee, Managing Director, WMC during the inauguration

strengthen our growth opportunities in India. Therefore, the

warehouse has more capacity than we will use currently,”

Hartel said. He emphasised that investing more than one

million euros for the facility will have an immediate effect on WMC’s ability to increase the efficiency of its logistics operations. “This will enhance the accuracy and traceability of our deliveries for our customers, and will ultimately help to keep the costs in line.”

The high-bay warehouse has a capacity of about 5000 pallet spaces and utilises ten layer racking. It uses Very Narrow Aisle (VNA) forklifts that are wire guided to retrieve goods.

The SAP warehouse management module ensures improved insight into the inventory and storage locations. Scanners will keep track of various transactions in the warehouse. Thus, the inventory information is made available to the operators in real time via a computer interface attached to the VNA. EP News Bureau - Mumbai

MEGGLE appoints Signet Chemical Corporation as business partner Signet will distribute the complete product portfolio of more than 20 products GERMANY-BASED MEGGLE, producer of pharmaceutical lactose has appointed Signet Chemical Corporation as their sole distribution partner in India for their entire range of pharma lactose and coprocessed lactose products. Under the new arrangement, Signet will distribute the complete product portfolio of more than 20 products viz. Tablettose, FlowLac, DuraLac, RetaLac, InhaLac, MicroceLac and Cellactose which covers all areas from solid dosage forms (including tablets, capsules, sa-

chets) to powder formulations and dry.

“We very much look forward to this important new partnership with Meggle,” said Harish Shah, Managing Director, Signet. “Their product range compliments our current portfolio and further strengthens our speciality product offering,” he continued.

Dr Egmont G Pfeifer, Director Business Group Excipients and Technology of Meggle in a statement said, “Signet has a long established and proven product management structure

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in India. Through their market focused networks, warehousing and logistics expertise supported by their dedicated technical and regulatory experts; they will effectively supplement Meggle’s market penetration in India.” Keeping in mind the growing needs of the pharma industry, with this strategic partnership Signet and Meggle will redefine their position as market leaders of excipients and global leaders of lactose respectively.

Dr Chua Siang Meng, Pharma Group General Manager, Meggle Singapore said,

“We are confident that Signet will promote and rightly position Meggle excipients to meet the commercial and technical requirements of our customers in India.”

Meggle is the leading producer and pioneer in developing and supplying innovative range of lactose and co-processed lactose products to the global pharma industry for more than 60 years. They do this through extensive expertise in R&D and then manufacture in round-theclock production using state-ofthe-art equipment.

Signet Chemical Corporation is India’s largest distributor of speciality excipients for the pharma and nutraceutical industry. Headquartered in Mumbai, it represents thirty globally renowned excipient producers from the US, Europe, the UK and Japan. With its highly qualified team of 85 professionals, Signet offers to the Indian formulators a spectrum of over 400 excipients for every formulation application and dosage forms.

EP News Bureau – Mumbai

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PHARMA ALLY

West Pharmaceutical Services opens facility near Chennai

Cryoport ties up with DHL

There are plans to expand production at the site to include West’s elastomer component business

To provide cryogenic logistics solutions for life sciences and healthcare clients

WEST PHARMACEUTICAL Services has opened its manufacturing facility in Sri City Special Economic Zone (SEZ) near Chennai, where the company will expand its growing primary packaging for injectable medicines business. The facility will produce seals used in primary packaging of injectable medicines.

In June 2012, West signed a 99-year lease on 72,800 square metres (approximately 783,600 square feet) of land in Sri City. It offers the advantages of a metropolitan location and was selected primarily on the suitability of land, availability of utilities, labour suitability, logistics and quality of life.

Construction began in August 2012 on 15,300 square metre (approximately 164,700 square feet). There

are future plans to expand production at the site to include West’s elastomer component business.

“West is experiencing an exciting period of growth and business expansion in Asia and we are proud to open our first facility in India,” said Donald E Morel, Jr, Chairman and Chief Executive Officer, West Pharmaceutical Services.

“This investment is important to our strategy of partnering with customers in India and Asia Pacific region in order to help them provide medicines to patients more efficiently, reliably and safely,” said Warwick Bedwell, President, Pharmaceutical Packaging Systems, Asia Pacific Region. He added, “With the facility complete, we anticipate a reduction in lead times for sup-

ply to our customers in India.

By leveraging our global sourcing activities and process engineering expertise, we expect to be able to carefully manage the overall costs of production.”

West’s presence in the Asia Pacific market includes a plant in Singapore, two plants in Qingpu, China and sales offices in Australia, China, India and Singapore.

West also owns 25 per cent of Daikyo Seiko, Tokyo, Japan.

Daikyo Seiko, founded in 1954, is a leader in the fields of pharmaceutical packaging and medical device components. The West/Daikyo relationship was formed in 1973 and includes joint marketing agreements and technology transfer and licensing agreements.

EP News Bureau-Chennai

CRYOPORT, PROVIDER of advanced cryogenic logistics solutions, has partnered with LifeConEx, a part of DHL Global Forwarding, to enhance and supplement DHL's cold chain logistics offerings including DHL Express' Medical Express to its life sciences and healthcare customers with Cryoport's comprehensive cryogenic logistics solutions.

With these new services, DHL is now offering advanced cryogenic logistics solutions as well as the best-in-class solution for shipping temperature-sensitive products and biological materials in a cryogenic state to its life sciences and healthcare customers.

DHL Global Forwarding currently has 45 certified life sciences stations around the world and they have stated that they will end the year with 65 integrated stations. These forwarding stations as well as dedicated life sciences warehouses and clinical trial depots will now be able to rely on Cryoport for cryogenic shipping. Cryoport believes this is an important element of DHL’s strategy to increase their business in temperature-controlled shipping.

Integral parts of this new service include the Cryoport Express Shippers that use a dry vapour liquid nitrogen technology, providing 10 days of holding time at minus 150 degrees centigrade, under dynamic shipping conditions combined with temperature monitoring throughout the shipping process. Cryoport's solutions offer a superior, more reliable alternative to dry ice, which needs to be re-iced every few days creating conditions for temperature excursions. This is of particular importance for the shipments of fragile biomaterials.

“As the life sciences industry continues to transform and evolve to meet growing demands for reliable frozen shipping solutions, we are thrilled to be combining forces with Cryoport,” stated David Y Bang, Chief Executive Officer, LifeConEx. Jerrell Shelton, Chief Executive Officer, Cryoport, stated, "This partnership with DHL is an important step in furthering our reach into the life sciences total addressable market.

EP News Bureau - Mumbai

Waters,Chinese Pharmacopeia Commission in agreement To open a joint open laboratory WATERS CORPORATION announced an agreement with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory. Scheduled to open before the end of 2014, the new joint open laboratory will focus on in-depth research of pharmacopoeia stan-

44 EXPRESS PHARMA August 1-15, 2014

dards, development of testing methods, methods validations and basic and advanced technical training of pharmacopoeia detection methods. Both ChP and Waters expect the laboratory to become one of the national technical support centres in the field of Chinese pharmaceutical standards.

"Waters is excited about our new collaboration with the Chinese Pharmacopeia Commission," said Art Caputo, Presi-

dent, Waters Division. "I am confident that this new joint open laboratory will make positive contributions to assuring drug quality control in China, it will quickly become an international leader in the field of traditional Chinese pharma standards."

At the collaboration agreement signing ceremony in Beijing, Secretary General Zhang Wei of the ChP pointed out that "the ChP-Waters Joint Open Laboratory cooperation would

become another milestone of the development of the ChP. This cooperation not only meets the needs of ChP’s own development, but also meets the demands of enhanced pharmacopoeia standards and improved public drug safety."

Located in the laboratory building of Beijing Zhendong Guangming Drug Research Institute, the new joint open laboratory is more than 400 square metres (more than 1300

square feet). The laboratory will be outfitted with a full complement of Waters chromatography and mass spectrometry technologies, including (but not limited to) a range of ACQUITY UPLC systems, ACQUITY UPC2 System, Xevo tandem quadrupole and timeof-flight mass spectrometers, and a Natural Products Application Solution with UNIFI. EP News Bureau – Mumbai

PHARMA ALLY PRODUCTS

Thermo Fisher Scientific transforms chromatography by reimagining UHPLC THERMO FISHER Scientific has unveiled a new high performance liquid chromatography system designed from the ground up to provide new levels of performance, productivity and usability when used as a standalone system or with the latest mass spectrometers.

The new Thermo Scientific Vanquish UHPLC looks different from standard UHPLC systems, and there are benefits to its clean design.

The monolithic case contains an instrument that combines the ruggedness of an integrated system with the flexibility and serviceability of a modular system. Vanquish stands about 25 per cent lower than comparable modular stacks for safety and convenience in the laboratory.

Thermo Scientific Vanquish UHPLC has been specially designed to optimise performance.

The new columns feature 1.5 μm solid core particles utilising core enhanced technology to take full advantage of the Vanquish system’s 1500 bar (22,000 psi) maximum pump pressure and flow rate up to 5mL/min for ultra-short diffusion path lengths and highly efficient separations.

Other features add to the system’s performance, throughput and usability, including: ● SmartFlow pumping technology designed for highly reproducible retention times and low baseline noise to enhance detection sensitivity. ● Temperature control capabilities, including direct heating and forced air temperature control modules in the column compartment, further enhancing separation efficiency and selectivity, as

46 EXPRESS PHARMA August 1-15, 2014

Thermofisher_Vanquish__DoorsOpen

well as retention time reproducibility. ● An insulated autosampler compartment with new air-toair cooling, which protects vials from water condensation, even in hot and humid environments. ● Gold-standard Thermo Scientific Dionex Chromeleon Chromatography Data System, familiar in laboratories around the world, which can calibrate the system automatically and unattended. eWorkflow and Intelligent Run Control automation are designed to enhance data quality and instrument efficiency instant data reprocessing paired with Cobra Peak Detection and Smart Link can speed data review significantly compared to manual procedures.

Chromeleon software supports chromatography and mass spectrometry functions simultaneously. ● Optional handheld tablet lets users conveniently monitor system status, check runs and make changes.

For high sample throughput applications, the optional Thermo Scientific Vanquish

Charger is a fully integrated robotic module that provides unattended, environmentally controlled sample management and loading into the Vanquish UHPLC system.

It accommodates up to nine sample racks, deep well plates or 20 shallow well plates. This includes a barcode reader with empty shelf detection and rack/well plate verification.

Users can add samples at any time, even while the instrument is operating, to enable maximum throughput and usability.

Hard carbon-coated ceramic injection valve and pump pistons are designed to deliver consistent, reproducible performance for 200,000 injections, further enhancing uptime by minimising maintenance.

The Vanquish’s Diode Array Detector is designed to generate high-confidence data over a wide linear range with high signal-to-noise performance, beyond the capabilities of variable wavelength detectors. Lowdispersion 10 mm and 60 mm flow cells provide high sensitivity levels and wide

Thermofisher_VanquishSystem_

Thermofisher_VanquishColumns

linearity for demanding applications.

Fused-silica LightPipe flow cells are designed to exploit low baseline drift for reproducible quantitation. Customers can acquire up to 10 signal channels simultaneously, and a spectrum 3D field at 200 Hz. Sensitivity, linearity, and spectral resolution can be tailored to suit the application using four programmable optical slit widths from 1 nm to 8 nm.

Contact details Stuart Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific 355 River Oaks Parkway San Jose, CA 95134 (408) 965-6408 office (415) 407-5474 mobile stu.matlow@ thermofisher.com www.thermofisher.com

PHARMA ALLY

HMXlaunches PCU-Fand PCU-R for comfort air conditioning BUILDING ON the success of the Ambiator, the first comfort conditioning product launched

by HMX, comes a range of highefficiency, environment-friendly, fresh air pre cooling units, the HMX PCU-F and HMX PCU-R.

HMX PCU-F The HMX PCU-F supplies cool fresh air to improve indoor air quality while simultaneously reducing the load on the compressor of the installed air conditioning system.

It uses our patented heat exchanger DAMA to pre cool fresh air being supplied to air conditioned spaces or air handling units in the most economical manner. DAMA works on the principle of indirect evaporative cooling (IEC) for sensible cooling of the primary air using water, without any refrigerant or compressor system. This reduces the tonnage load (TR) on the

installed HVAC system which would have been otherwise used to cool the fresh air. This in turn reduces the total tonnage (TR) requirement for the project, and saves a large amount of energy that is otherwise required to condition the ambient air. The primary air is cooled without adding moisture to it and in the process the dry bulb temperature and the enthalpy of the fresh air are reduced substantially.

The standard HMX PCU-F consists of an air filter, patented dry air moist air (DAMA) heat exchanger, an optional coil (direct expansion – DX or chiller water –CHW), supply air fan and its motor. The unit is then connected to ducts that supply the clean pre-cooled fresh air to the air handling unit or directly to the conditioned space. The HMX PCU-F is also an excellent option where the entire fresh air load is handled

by the chiller or a DX system.

Retrofitting of the existing fresh air handling unit is also possible with PCU-F. Here the air is passed only once through the space due to which there is zero contamination. Positive pressure is maintained inside the room and hence, a separate exhaust system is not required.

This machine is available from 500 CFM to 20000 CFM in standard options, and can also be customised to suit project requirements. The PCU-F can be used in various sectors like pharma, hospitals, hotels, theatres and even applications such as process cooling or to retrofit an existing fresh air unit.

HMX PCU-R HMX PCU-R requires pre cooled fresh air and return air is available. The objective of PCU-R is to replace inefficient and maintenance intensive

energy recovery wheels, heat pipes, air-to-air heat exchangers, etc. with a more efficient and economical solution that is both reliable and sustainable. The annual energy savings with the PCU-R is substantially higher to the tune of 50–60 per cent as compared to the existing options for energy recovery devices!

The air flow is made such that the cold return air, by design available at room temperature of 24°C and 55±5 per cent RH, is used as secondary air for the HMX DAMA. The standard HMX PCU-R is normally a double-decker arrangement consisting of an air filter, our patented dry air moist air (DAMA) heat exchanger, a supply air fan and its motor in the upper deck.

The lower deck comprises an air filter, a return air fan and its motor, and a plenum. It is not

possible to retrofit an existing system as a separate exhaust system is required to carry the return air to the PCU-R. HMX PCU-R is available in sizes from 500 CFM to 6000 CFM. The PCU-R can be used for varied applications such as pubs, shopping malls, IT industries, offices, commercial complexes, etc.

Contact details ATE Enterprises 43,Dr V B Gandhi Marg, Fort, Mumbai - 400 023, India T: +91-22-2287 2245 Ext : 134 M: +91-91676 46480 F: +91-22-2204 1690 W: www.ateindia.com | www.ategroup.com

HRS launches hot water systems HRS HOT water system is the most versatile and compact hot water generation system. It provides highly efficient solution to instantaneous hot water generation using energy efficient heat exchangers (Funke Brazed or Gasketed plate heat exchanger or Ecoflux corrugated tube heat exchanger).

HRS Hot water systems can also be installed with storage (buffer) vessel for semiinstantaneous applications and in conjunction with solar based hot water systems. A hot water system not only heats the water to a desired temperature using low pressure steam but also maintains the required temperature of water with better temperature control

using automation and control.

HRS Hot water systems has its applications in pharma – single fluid heating and cooling systems, food, HVAC, hospitals, hotel, textile and breweries.

The system is compact and complete package solution, indigenous design for the heart of the system - heat

To subscribe: bpd.subscription@expressindia.com

exchangers, customised solutions to meet all process requirements, pre-assembled skid for ease of installation, versatile on heating controls for consistent and desired temperatures, hassle free condensate removal and recovery with no energy losses, standard units supplied with

control packages comprises of PID controllers. Special control packages available with PLC systems.

The benefits of HRS Hot water systems are hot water generation is instantaneously available for fluctuating process loads and urgent demands, less energy consumption – system designed with heat exchangers with very high heat transfer rates and efficiency, least cost of ownership—inexpensive solution in terms of initial capital costs, installations, operation and maintenance cost, most reliable to suit the process– ensures accurate temperatures for hot water required for the most heat sensitive processes, compact yet efficient – Upto 75 per cent less space required for installation

when compared to conventional hot water tank heating systems.

The system eliminates the direct contact of hot water and steam, utilises sensible heat to deliver optimum results, eliminates the need for regular supervision, insulation of the machinery ensures that there is no radiation loss through hot water storage tanks, low operating cost and lesser steam losses.

Contact details HRS Process Systems 201/202 Karan Salene, 851, Bhandarkar Institute Road, Pune 411004, Tel: 020-2566 3581 / 82 Fax: 0202566 3583 Email: info@hrsasia.co.in Website: www.hrsasia.co.in

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Industrial Equipwash launches powder and liquid samplers INDUSTRIAL EQUIPWASH has launched powder samplers and liquid samplers.

made of FDA approved plastics while the rest of the sampler is made of 316 stainless steel. The stainless steel cups are welded to the shaft so that they do not have a chance to drop into the tank.

Sampler is sterilisable, easily cleanable, and is ideal for sampling of large volumes (20cc and up) from drums, tanks, mixers, reactors, etc.

Powder samplers These powder samplers with interchangeable dies for unitdose sampling are available in different diameters, lengths and models. Made of 316 stainless steel, these samplers may have one sample port or multiple sample ports for simultaneous sampling at several locations. Any number of sample ports may be blocked with blank dies.

Single, duplicate or triplicate sampling at each sample port is possible.

Duplicate and triplicate samples are obtained from exactly the same spot at each sample port with just one

insertion of the sampler into the powder bed. Segmented design samplers facilitate sampling from large blenders with roof height limitation.

Stainless steel inner shaft is hollow to make the sampler lighter. Inner shafts, custommade of Teflon are available.

The samplers are passivated

and easily cleanable with movable conical end pieces.

Liquid samplers This liquid sampler is custommade to suit the customer’s sampling bottles and it takes samples directly into the bottles. The bottles are (preferably plastic) held inside

stainless steel cups and do not get wet outside. The same sampler may be used with different size bottles by simply changing the bottle adapters.

The bottle adapters and the bottle sealing closures are

Contact details Industrial Equipwash 8B, Surat Singh Indl. Estate, B/h. Agarwal Indl. Estate, Off SV Road, Jogeshwari (W), Mumbai 400 102 Tel:(022) 2679 7941 fax : 2679 2936 e-mail : iewi@mtnl.net.in website : www.iewi.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

BANGALORE G.M. Khaja Ali The Indian Express Ltd Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Ext. 108 Mobile: +91 9741100008 Fax: 080- 22231925 Email id: khaja.ali@expressindia.com

BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express Ltd Business Publication Division Express Building, 9&10, Bahadur Shah Zafar Marg, New Delhi- 110 002 Board line: 011-23702100 Ext. 668 Mobile: +91 9999070900 Fax: 011-23702141 Email id: ambuj.kumar@expressindia.com

HYDERABAD E.Mujahid The Indian Express Ltd Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936 Fax: 040 23418675 Email Id: e.mujahid@expressindia.com

CHENNAI Yuvaraj Murali The Indian Express Ltd Business Publication Division New No. 37/C (Old No. 16/C)

KOLKATTA Ajanta Sengupta The Indian Express Ltd Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati,

48 EXPRESS PHARMA August 1-15, 2014

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

AHMEDABAD Rajesh Bhatkal The Indian Express Ltd 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com BHOPAL Ambuj Kumar The Indian Express Ltd F-102, Inner Court Apartment, 1st Floor, GTB Complex, Behind 45 Bungalows, Bhopal - 462 003 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com JAIPUR Ambuj Kumar The Indian Express Ltd S2, J-40, Shyam GHP Enclave, Krishna Marg, C-Scheme, Jaipur - 302 001 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com

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.

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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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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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When purity is 100% critical You have to be 100% sure

Pharmalab, the name synonymous with Purity for over five decades is also the world’s leading supplier of Multi-effect Distillation Units to produce water for inject (WFI) meeting all requirements of United States Pharmacopoeia (USP), the European Pharmacopoeia as well as other national specification.

All documentation such as Design Qualification (DQ), Installation Qualification (IQ), and Performance Qualification (PQ) with standard operating Procedures (SOP’s), Endotoxin test & factory acceptance testing (FAT) is provided as standard.

Special Features can be offered as option: • Simultaneous WFI and Pure Steam Production.

• Proportionate capacity control with full automation • Unique degasifying column for removal of non-condensable gases from feed water • High energy saving (less plant steam) and cooling water saving (80% less) models • SCADA communication and 21 CFR Part 11 compliance • Drain cooling arrangement to meet environmental norms • Manufacturing & performance to meet many international guidelines like ASME BPE, GAMP, ISO 9001-2000, HTM 2010 etc • Self Sterilization mode • Stand-by mode

Pharmalab India Private Ltd. Kasturi, Sanghvi Estate, 3rd Floor, Govandi Station Road,Govandi, (East), Mumbai - 400 088.Tel no: +91-22-66 22 9900 Fax: +91-22-66 22 9800 E-mail: pharmalab@pharmalab.com  Website: www.pharmalab.com EXPRESS PHARMA

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For Vacuum/ Pressure Transfer of Powder/ Granul es/ Tabl ets Crystal l ize M aterial in Pharma, Bul k Drug, Food, Chemical , Pl astic & Paint I nds.

Dilute Phase Material Conveyor Capacity: 50Kgs.-5000Kgs/Hr.

Granulator-Shredder Capacity: 800Kgs./Hr

Dense Phase Type 50Kgs.-5000Kgs/Hr

Ribbon Blender 50Kgs.-5000Kgs./Hr.

In-line Rotary Sifter Vibro Sifter also avail.

Screw Conveyor 50Kgs.-5000Kgs/Hr.

Octagonal Blender 50Kgs.-5000Kgs./Hr Conical /V-type also avail.

Batch Weighing System Bag/Drum Fill-up

Other Products: Bag Dumping Station # Jumbo Bag/ Big Bag Loading-Unloading System # Bin Activators & Discharger # Flexible Screw Conveyor # Capsule Loading/ Tablet Press Loading/ Blender Loading System # Bunker with Loading/ Reactor Loading system # Lumps Breaker # SS/ MS Storage Silo/ Bunker # Rotary Valve # Powder Conveying System Mobile type…………

For more details, please contact to:

A L ! X automation syst em TM

B/17, Adke Compound, Suryanagar, Vikhroli-W, Mumbai-400083. INDIA

Tel/Fax: +91-22-25776356 / +91-22-25796851.

Mobile: +91-9833297671 / +91-9819030056 e-Mail: info@powder-transfer.com / powdertransfer@gmail.com

www.powder-transfer.com

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

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules 58

August 1-15, 2014

Wash Down Hose Station

SIP MODULE

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

Top Tank / Reactor Sampler

Flush Bottom valve

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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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VISCOMETER

127, Bussa Udyog Bhavan T.J Road Sewri Mumbai - 400015

Tel: 91 22 24166630 / 24173493 Fax: 91 22 66627766 E-mail: support@rosalina.in, www.rosalina.in

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Identification and quantification of Organic process impurities by LC-MS/MS – GCMS/MS. Inorganic impurities by ICP-MS and A.A.S with Graphite furnace, IC Solvent impurities by GC-MS/MS and GC head space with MS.

Quality in our genes…

Genotoxic impurity quantification Genotoxic Studies.

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

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

Qualification of Impurities.

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

TECHNOLOGIES FOR IMPURITY PROFILE STUDIES

ACCREDITATIONS

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

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

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

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

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

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Advertise in

Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Yuvaraj Murali 09710022999 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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UBM India the organizer of CPhI & PMEC - South Asia's biggest and most comprehensive Pharma event

proudly

announces

the

launch

of

PharmaLytica. PharmaLytica integrates UBM's expertise and understanding of Pharmaceuticals, BioServices, Analytical & Lab Services with the limitless possibilities on the Pharma Industries and presents it as one solid B2B package.

That’s what we call - Evolution Accelerated

25 - 27 September 2014

Bangalore International Exhibition Centre, Bengaluru, India

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EXPRESS PHARMA

PHARMA LIFE INSIGHT

TSP: Redefining pharmaceutical marketing

KRISHNA SINGH, Founder Director, GlobalSpace Technologies

Tablet PC-based digital platforms hold the potential to change the age old marketing paradigms employed by pharma companies. An outlook by Krishna Singh, Founder Director, GlobalSpace Technologies “WHO IS viewing what? And when?” The answers to these two questions revolutionised the whole media industry. The TRP system or Target Rating Point as a means of determining how often an advertisement is seen by a specific target audience is unique to the industry.

It gives an idea of the amount of exposure an advertiser is getting with its target. Gone are the days when media planning was done on assumptions and perception of advertising slots. Today is the TRP age ruled by data-driven buying.

The success of any advertisement is measured by the type of advertisement and its slot.

Marketers can measure exactly which media slot will serve their purpose, make accurate decisions and get better returns on their marketing spend.

Coming to the pharmaceutical industry, it is evolving at a pace like never before. Pharma companies are allocating huge marketing budgets to promote their products to beat fierce competition. Companies are more open to technologies to maximise their investment, but they are still waiting for a TRP like system. This problem has been resolved to some extent in case of OTC products, where the marketer can choose TV or mass media to market their products. Here, the TRP system plays a vital role in marketer’s strategic decision making. Extremely competitive and highly regulated, pharma marketing is even more intense, when it comes to prescription

drugs. If we compare the mass media eco-system to the prescription drug eco-system, we find a lot of similarities.

Here the ‘Target Group’ is the ‘Doctor’ and ‘Medical Representative’ is the medium, but the irony is, we can’t actually find out the amount of exposure of any brand a doctor is having while the MR does his ‘detailing visits’. The sales force of a typical pharma company, an MR visits the doctor, shows the brand presentation to him and moves to the next doctor.

While we can evaluate the first aspect of promotion i.e. the type of presentation, it is difficult to measure the time spent on each brand by a MR in a doctor’s clinic. There is no TRP system that works here to help marketers in their decision making. On an average, pharma companies spend 15-20 per cent of their revenue on sales and marketing, where BTL promotion involves 60 per cent of all promotional spending.

In the US, pharma companies spend a whopping $8,290 per doctor for detailing. Even after spending so much on detailing, the time spent on each brand by a MR in doctor’s clinic can’t be measured. Indian pharma market is highly competitive with an average clinician being called by more that 15-20 MR’s on a daily basis, hence an average MR’s ‘Detailing visit’ to the doctor takes one to two minutes, wherein he is expected to promote more than 10-15 brands. Among these, the pharma company

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strategically wants to focus on two to three brands(newly launched drugs) where the sales person is expected to get more time from doctor. While doing review of new launches or focused brand promotions, it is very difficult to find out whether the loopholes lie in their marketing strategy or in its implementation.

It is quite common now that due to changing market dynamics and increasingly busy schedules of the doctors, the productivity of traditional product detailing is fast waning. As a result, pharma companies are encountering huge challenges in the process of generating prescription demand for their respective products by taking a commensurate share of the mind of the physician. The need of the hour is to

transform the traditional detailing with a new age tool which can help pharma companies create and facilitate a meaningful and relevant customer interface. This would in turn help drive better value for time spent by a physician listening to MR’s detailing.

Migrating to the tablet PCbased digital platform is sufficient to give the pharma strategy and marketing team an insight into the ‘in clinic on call promotion analytics’ in the form of TSP, the time spend on each brand promotion in doctor’s clinic, the equivalent of TRP in mass media. If the sales of a new launched brand A are not increasing, we know that brand A has not been paid attention while detailing, and if the TSP data says something else, it’s time to take corrective

actions in promotional strategy. The use of TSP will make pharma marketer’s life easier and their decisions more accurate.

Such digital platforms are enabling pharma frontline sales executives to do their job better by augmenting their capability to perform traditional primary role of scientific promotion of drugs. All the relevant scientific information can be collated on the fingertip of a medical representative alongwith preparation of the information deck for a specific audience such that the MR will be able to respond to a doctor’s query on real time basis, saving customer’s precious time. The medical communication is designed, organised and disseminated in an enhanced manner so that the physician finds it relevant to his practice and gets value out of his interaction.

New concepts like on-demand customised detailing and real time QMS could transform the way pharma companies interacts and interface with their customers. In times to come, the digital platform can help integrate the entire healthcare ecosystem including the trade channels and hospitals giving new dimension to the entire industry and bring in 360 degree marketing capabilities to the forefront. Marketers will come up with sharper marketing strategies with measurable ROI for every activity. It’s going to transform the very way medical and scientific information is created and disseminated in the future.

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PHARMA LIFE APPOINTMENTS

Jitendra Tyagi appointed as BMS India Country Head He joined BMS in 2010 as Director- MRCEI JITENDRA TYAGI has been appointed as the country head of Bristol-Myers Squibb India.

He will report to Michael Norman, General Manager – Middle East, Africa and India.

Tyagi is known for his ability to think strategically, resolve complex business challenges and connect and collaborate.

Tyagi brings a broad range of experience to his role. He joined BMS in 2010 as Director, MRCEI. In the last few years he performed diverse

commercial roles in India such as Business Unit Head, market research, market access, key accounts, business excellence and patient support programme. He was the project leader who ensured a smooth transition of the diabetes business as well as employees to Astra Zeneca India.

In his most recent role in BMS, he led the critical care and cardiovascular business unit, where he also managed efficiently the alliance

with Pfizer.

Prior to joining BMS India, Tyagi spent more than 21 years at Novartis India in a number of leadership positions. Tyagi has earned his diploma in business management from Wellingkar Institute of Management, Mumbai and underwent an executive education programme from Columbia Business School.

Siddharth Mittal joins Biocon as CFO He has more than 15 years of global and diversified experience SIDDHARTH MITTAL, President – Finance has been appointed as Chief Financial Officer, Biocon effective August 1, 2014.

He joined Biocon in May 2013 and takes over from Murali Krishnan, who re-

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Adil Zainulbhai joins Cipla as Independent Director He was the Chairman of McKinsey India CIPLA HAS appointed Adil Zainulbhai as an independent director on the Board. Zainulbhai retired as the Chairman of McKinsey India after a distinguished career consulting Indian corporations and their boards. He spent 24 years in the US where he led McKinsey’s Washington Office and founded the Minneapolis office before returning to India.

Dr YK Hamied, Chairman, Cipla said, “Zainulbhai’s 30 years of experience across various industries in India and globally will add a valuable perspective to our Board of Di-

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rectors.”

Zainulbhai said, “Cipla has had a huge impact in providing affordable pharmaceuticals to the world while building a strong company. I look forward to helping Cipla become even more successful.”

Zainulbhai counsels the CEOs and promoters of large companies in a range of industries and has helped several such companies become global leaders. He works closely with Government leaders to drive growth, raise living standards, strengthen key sectors of the economy and

improve healthcare, education, and welfare.

Recently, Zainulbhai co-edited the book, Reimagining India: Unlocking the potential of Asia’s next superpower, a seminal publication of 65 essays from leading thinkers around the world to explore the challenges and opportunities facing the country.

Zainulbhai grew up in Mumbai and graduated in Mechanical Engineering from the Indian Institute of Technology. He also has an MBA from Harvard Business School.

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tires after more than 30 years of distinguished service with the organisation.

Mittal is a Chartered Accountant (India) and a CPA (US) and has more than 15 years of global and diversified experience.

Prior to joining Biocon, he was the Vice President-Finance and Corporate Controller with a leading USbased multinational information technology company based in Bangalore.

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PHARMA LIFE CAMPUS BEAT

ABLE conducts BIRAC supported series at University of Rajasthan The aim of the programme was to motivate the student community THE ASSOCIATION of Biotechnology Led Enterprises (ABLE) has conducted the first of Biotechnology Industry Research Assistance Council (BIRAC) supported series of 'Stimulating Bio-Entrepreneurs' talks at the Center for Converging Technologies (CCT), University of Rajasthan to inspire future entrepreneurs.

The aim of this programme was to motivate the highly energetic, skilled and self-confident young student community, to instil and incite creative minds to build new ventures and support them. According to Dr Renu Swarup, Advisor, DBT & MD, BIRAC, “The aim

of the series is to spark an entrepreneurial interest in young minds and the selected universities will provide an ideal setting. After the first series of eight talks in four university clusters, the programme will be rolled out in several others.”

Lead coordinator Dr K Vijayaraghavan from Sathguru Management Consultants, discussed with the students the, “Roadmap to entrepreneurship” and encouraged them to develop a global perspective and utilise the Indian ecosystem to adopt Life Sciences as their domain to create enterprises. He also mentioned the value creation in any innovative idea.”

Dr Ashok Bharghava, Chief Executive Officer, Ayushraj shared his journey of entrepreneurship to create a successful enterprise in building manufacturing capacity for nutraceutical and natural herbs.

Prof Mahesh Sharma, University of Rajasthan on behalf of Plants Med Laboratories shared his business model and opportunities available in the online marketing space.

Maninder Sra from Ob-

serve Design and an ABLEBEST 2013 Winner presented his team’s digital sanitiser prototype and gave a perspective on team value and on how funding instils confidence in transforming ideas into a very successful venture.

BIRAC also encouraged the students to apply for the ongoing call of its flagship scheme – Biotechnology Ignition Grant (BIG), which supports innovative ideas with grant-in-aid amount upto ` 50 lakhs. This highly interactive session enthused the participating students and young research scholars.

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Students of Principal KM Kundnani College of Pharmacy celebrate Silver Jubilee The function was attended by a large number of staff and students both from India and abroad PAST STUDENTS of Principal KM Kundnani College of Pharmacy of 1985-1989 batch recently celebrated Silver Jubilee of graduation in Mumbai.

Dr JK Lalla, former Principal of the College (1971-2002)was the Chief Guest of the function. The past and the present teaching and the non-teaching staff of the college and the students were the invitees. The function was attended by a large number of staff and students both from India and abroad. Lalla, Dr VS Velingkar, the present principal of the college, Dr CI Jolly from

Taching and non-teaching staff and students during the event

Kerala, Dr PY Shirodkar, Dr AY Nimbkar, Dr UB Hadkar, Dr SS Bhalerao, Dr Jessy Shaji were felicitated.

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The administrative staff was represented by Murli Duseja. Non-teaching staff was represented by PK Pawar

from Chiplun, Ashok Patil, Ashok Gangan, Pradeep Masurekar, Vijay Chalke, Subash, Gorivale, Ram Gorivale, Kr-

ishna and Shashikant.

The event was organised by the alumni students. Pramila Girish Naik, Sujit Sansgiri from the US, Nikhil Joshi, Rajaram Rajadhyakshya and Milind Mangle, Milind Mangle hosted the ceremony. Naik distributed copies of brochures edited by her and Rajadhyakshya. Dr Lalla distributed copies of his message prepared from vast experience for the students to guide and help them in future course of life.

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PHARMA LIFE

Three women lead Novartis Biotechnology Leadership Camp They will represent India at International BioCamp in Basle, Switzerland THREE WOMEN, Satarupa Barma and Aditi Ramnath from the Indian School of Business (ISB), Hyderabad and Nidhi Hans pursuing a PhD at the International Centre for Genetic Engineering and Biotechnology (ICGEB) took top honours at the recently concluded Novartis Biotechnology Leadership Camp (BioCamp) in Hyderabad.

The three participants were

selected after an intense threeday programme to represent India at the International BioCamp being held at the Novartis Campus in Basel, Switzerland from August 24 - 27, 2014.

Speaking on the occasion, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India said, “Novartis Biotechnology Leadership Camp - BioCamp, continues to gain in

stature. This year three women created history by taking the honours. BioCamp maintains its position as a platform to provide students the opportunity to interact with leaders in the pharmaceutical area outside their area of study. We hope to engage with a wider group of students as we grow the programme.”

The inaugural address was delivered by K Srinath Reddy,

President, Public Health Foundation of India (PHFI) who touched upon the challenges facing India in the area of public health and what we as a country can learn from the globe.

Other speakers included Vishy Chebrol, co-Founder India Life Science Funds who focused on how entrepreneurs need to pitch for funding and Dr Prabuddha Ganguli, Chief Executive Of-

ficer, Vision IPR who focused on the value of intellectual property rights. Anu Acharya, Chief Executive Officer, mapmygenome.com shared her entrepreneurial experience in preparing a business plan. The valedictory address was delivered by Juergen BrokatzkyGeiger, Global Head Corporate Responsibility, Novartis.

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INITIATIVES

SBI donates MMC to AmeriCares India The new mobile medical clinic will enable AmeriCares India to reach 19 new locations providing approximately 20,000 consultations annually THE STATE Bank of India (SBI) has donated a fullyequipped mobile medical clinic (MMC) to AmeriCares India, making it the seventh MMC in India. The new MMC will enable AmeriCares India to reach 19 new locations providing approximately 20,000 consultations annually. The team received the MMC from Abhijit Guhathakurta, Chief

Members of the AmeriCares India staff and board of directors with SBI bank officials

General Manager (Corporate Banking), SBI with board members and bank officials present.

"Healthcare is an important part of SBI' s corporate social responsibility vision. We visited the slums where AmeriCares works and were very impressed. We look forward to a long association," said

Guhathakurta.

The MMC is equipped with a portable pathology laboratory that enables testing for blood haemoglobin to detect anaemia, blood sugar to detect diabetes and to detect and assess end-organ damage due to diabetes and hypertension.

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USVsupports wildlife conservation Sponsors Sunjoy Monga’s book 'Mumbai Safari' as part of its CSR initiative AS PART of its environment protection programme, USV, under the ‘Flora and Fauna’ initiative, has sponsored a book by environmentalist, Sunjoy Monga titled ‘Mumbai Safari’ - Nature in the Extreme.

The book explores the incredible wealth of biodiversity across a range of habitats within and immediately around one of the world’s most congested urban regions.

The book was launched by Leena Gandhi Tewari, Chair-

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person, USV and Prashant Tewari, Managing Director, USV in the presence of Praveen Pardeshi, Principal Secretary, Revenue and Forests Department of Maharashtra. Also, present were Homi R Khusrokhan President Bombay Natural History Society, Dr Ramani, Director Bombay Natural History Society, Julio Ribeiro and Abodh Aras, Director, WSD. Another CSR initiative by USV is the Dr Susheela Gandhi

(L-R) Prashant Tewari, Praveen Pardeshi, Leena Tewari, Homi Khushrukhan, Debabrata Bhandary and Sunjoy Monga

Centre for Women, a Mumbaibased institution dedicated to

the empowerment of underprivileged women through the

medium of dance. Tewari started the centre with the sole objective of upliftment of women from the weaker sections of the society. The centre is specially meant for the physical, mental, spiritual and economical empowerment of women and girls so that they can be made strong, confident and be able to transform themselves into a good person and have a bright future in life.

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