Express Pharma (Vol.12, No.14) May 16-31, 2017 by Indian Express

VOL. 12 NO. 14 PAGES 76

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Wockhardt intends to acquire global leadership in the field of antibiotics Express Pharma to host FDD Conclave in Hyderabad

16-31 MAY 2017, ` 40

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CONTENTS MARKET

Vol.12 No.14 May 16-31, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor

SKILLING UP

Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli,

‘CHONDRON HAS BEEN SAFELY TESTED AND ADMINISTERED TO MORE THAN 350 PATIENTS OVER LAST FIVE YEARS’

WOCKHARDT INTENDS TO ACQUIRE A GLOBAL LEADERSHIP IN THE FIELD OF ANTIBIOTICS

EXPRESS PHARMA TO HOST FDD CONCLAVE IN HYDERABAD

5TH EDITION IPHEX CONCLUDES IN HYDERABAD

Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director

Skilling has emerged a priority in India’s pharma sector with LSSSDC, industry associations and consultants spearheading initiatives in this direction. Yet, are all the pieces needed to plug the gaps in place? | P22

Pravin Temble Senior Designer Rekha Bisht

RESEARCH

Graphics Designer Gauri Deorukhkar

PHARMA TECHNOLOGY REVIEW

MANAGEMENT

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING

Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South

Debnarayan Dutta - East

ASTRAZENECA IMMUNOTHERAPY WINS FIRST APPROVAL IN BLADDER CANCER

Marketing Team

Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry

PRODUCTION General Manager BR Tipnis

POLLUTING NANOPARTICLES GET INTO BLOOD AND DAMAGE HEARTS: STUDY

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

CONNECTING DIABETES CARE TO THE INTERNET OF THINGS

SANNER ACHIEVES INCREASE IN ANNUAL SALES

INNOVATIVE DRUG DELIVERY PLATFORM RELIES ON TELOS REAGENT CHIPS

Rajesh Bhatkal

THE RIGHT BALANCE?

WHAT MORE FOR CLINICAL RESEARCH IN INDIA?

QUALITY WITH A SUPERSIZED Q

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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EXPRESS PHARMA

May 16-31, 2017

EDITOR’S NOTE

Bridging the skills gap

eleaguered by warning letters and import recalls, pharmaceutical companies in India seem to be finally investing in upskilling their employees. This year’s annual GMP special issue (Express Pharma, May 16-31, 2017) has experts highlight some of these skilling initiatives. As Ranjit Madan, CEO, Life Science Sector Skills Development Council points out, the cost of errors due to substandard skills at any level, far outweighs all costs incurred to undergo the exercise, be they time or resources, including monetary. And cost is obviously a determining factor. Which is why ex-US FDA and current head of NIPTE, Dr Ajaz S Hussain’s insights on strategies for making high pharmaceutical quality affordable, a continuation of his previous articles for Express Pharma, is very relevant for both academia and industry stakeholders. Prodded by the DCG(I)'s mandate that by January 1 next year, all employees associated with the manufacturing process should have some form of accredited certification, there is now a flurry of companies and professionals inquiring about and signing up for various skilling programmes. The courses range from the Advanced Program in Pharmaceutical Quality Management (APPQM) conducted by NSF in association with the Indian Drug Manufacturers Association (IDMA) to Pollux Life Sciences' courses, affiliated to LSSSDC, which start from counselling of science and pharmacy undergraduates to training of graduates for roles ranging from quality control chemists and the like. SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and Director - Global Strategy (Technical), Micro Labs underlines the need to go beyond training (the how of a practice) to education (the why of the how). True education is about changing not just actions but mindsets. Martin

A high 64 per cent of survey respondents attributed noncompliance to shortage of skilled staff

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10 EXPRESS PHARMA May 16-31, 2017

Lush, Global Vice President, Pharma Biotech and Medical Devices, NSF Health Sciences thus stresses that their courses, like the APPQM, aim to “change the way people think.” The severity of the skill gap in India's pharma sector can be gauged from a June 2015 survey by Deloitte, titled 'Managing growth through better compliance management'. A high 64 per cent of survey respondents attributed non-compliance to shortage of skilled staff (in their risk and compliance teams), followed by challenges in implementing cGXP guidelines (52 per cent). Proactive companies have always had in house skilling initiatives. To name just one, Zydus Cadila's QueST - Quality excellence by Sustainable Transformation — which started in 2015, according to their annual reports. During a panel discussion at IPA's Indian Pharmaceutical Forum 2017, Pankaj R Patel, CMD, Zydus Cadila - Cadila Healthcare spoke of the company’s tie up with two pharmacy and science colleages. As part of this programme, second year students train at Zydus Cadila - Cadila Healthcare during their vacations and if good enough, are later absorbed post graduation. But commitment from the top management is clearly not enough. This year’s article from McKinsey cautions that only a few companies have been able to build a quality culture where everyone from the 'top floor to shop floor' takes ownership of quality and feels responsible for it. Industry response has tended to be “waiting for someone else to make the first move,” as Hemant Deshpande, Managing Partner, Pollux Life Science Solutions points out, and this has cost the sector dearly in terms of global reputation. We hope that our 2018 GMP edition will have more good news for us. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘CHONDRON has been safely tested and administered to more than 350 patients over last five years’ Yash Sanghavi, MD & CEO and Satyen Sanghavi, CSO & ED, RMS Regrow elaborate on the potential of regenerative medicine and their offerings in this growing sphere, in an interaction with Usha Sharma

The DCG(I) recently approved your stem cellbased therapy to treat cartilage defects. How is it different from other existing stem cell therapies in the market? Our product is fourth generation Autologous Chondrocyte Implantation (ACI), a novel medical procedure to treat articular cartilage defects of knee and ankle joints. ACI is a minimally invasive medical procedure which involves: a) Step one includes harvest of healthy cartilage tissue from patient’s knee joint with arthroscopy (key hole). Collected healthy cartilage tissue specimen is sent under controlled temperature at 28°C to our Cell Processing Center (Laboratory) for culturing about three to four weeks. b) Step two includes small opening and implantation of patient’s own cultured cartilage cells (chondrocytes) onto the cartilage defect area of the same patient. c) When cartilage cells (chondrocytes) are implanted into a cartilage defect, chondrogenesis is initiated wherein new hyaline cartilage is formed and thus joint is preserved. How big is the Indian cartilage regeneration

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more than 350 patients including clinical trial participants over last five years. The following is the city wise breakdown on the clinical trials conducted for Chondron. Name of the city Number of cases

Yash Sanghavi, MD & CEO, RMS Regrow

Satyen Sanghavi, CSO & ED, RMS Regrow

market and what is its growth percentage? The Indian orthopaedic market is huge. There are about four to five lakh joint replacements, repair and reconstruction cases performed in India annually and is growing at rate of 15 per cent per annum. The orthopaedic implants segment generated the highest revenue in the global market in 2015, accounting for one-third share. The reconstructive joint replacement segment accounted for nearly two-thirds share of the global orthopaedic implants market in 2015. Reconstructive joint replacement was the highest contributor in the orthopaedic implants market and projected to grow at a CAGR of 3.4 per cent from 2016 to 2022. Culturally in India, a lot of activities at home or in public spaces such as temples involve bending, kneeling down or

squatting on the floor and for a person suffering from osteoarthritis, performing such tasks can become near impossible. In India, osteoarthritis is the most prevalent form of arthritis, affecting over 15 million adults every year, with over 60 million cases likely by 2025. There is no specific treatment proven as yet that can reverse joint damage caused by osteoarthritis. Hence, the objectives of osteoarthritis management are to reduce the level of pain, reduce inflammation, slow cartilage degradation, improve function and reduce disability. In India, where did you conduct the clinical trials and how many healthy volunteers? CHONDRON has been safely tested and administered to

Chennai

Hyderabad

Bangalore

Ahmedabad

Delhi

Pune

Mubai

Other cities include Ranchi, Nashik, Kochi, Coimbatore, Kerala, Gurgaon, Mangalore, Chandigarh, Surat, Calicut, Goa, Vadodara, Visakhapatnam, Bhilwara, Jammu, Aurangabad, Jaipur The distribution of Chondron cases as per indication are ◗ 326 cases for knee ◗ 29 cases for ankle ◗ 2 cases for shoulder What have been the results of the study? Regrow is offering a solution which is:P: - Permanent – regenerated E: - Easy (minimally

invasive) N: - Natural biological solution (Your own cells are healing you) The results received from the trial have proved excellent safety and efficacy results. Patients have scored all end points and have reduced pain, increased mobility and new cartilage generation. There has been a success rate of 97 per cent and patients have gone back to playing professional sports. When do you plan to commence post marketing surveillance? We have already received market authorisation to conduct PMS. As per Drugs & Cosmetics Act, every new drug in India must undergo a four years safety evaluation to track any safety issues. However, we are commercially launching the product in May. We are in talks with major government, private, state and military hospitals to offer this product to the patients. How much time does it take for cartilage tissue implantation? Which is the age group you are targeting for it? The ideal age group for cartilage tissue implantation is between 15 to 65 years. With Continued on Page 16

MARKET I N T E R V I E W

Wockhardt intends to acquire global leadership in the field of antibiotics Dr Murtaza Khorakiwala, MD, Wockhardt, shares the challenges faced with regards to AMR and his vision to create a continual stream of novel antibacterial therapies in a conversation with Mansha Gagneja Why is antimicrobial resistance a global concern? Today, global mortality due to anti-microbial resistance (AMR) is more than seven lakhs, which is slated to increase up to 10 million by 2050. Due to AMR, the additional healthcare cost per year is more than $4 billion globally. Moreover, there has been collateral damage to healthcare settings across the globe, with compromised ability to manage various surgeries, organ transplants, deliveries etc. AMR through various multi-drug resistant superbugs as Enterobacteriaceae, Acinetobacter, ESBLs, Salmonella, Pseudomonas, Staphylococcus and Streptococcus, is leading to loss of lives at a great extent due to the uncontrolled deadly infections. Thus putting the entire healthcare industry under threat. Why is research for new tools to combat drug resistance declining? The research on new antibacterial agents is declining due to its economic unattractiveness. Antibiotics which are prescribed for shorter courses of one or two weeks do not generate sufficient return on investments to recoup the cost of research. Therefore, big pharma companies have vacated the field to focus on more lucrative lifestyle diseases requiring long-term therapies. This is paradoxical since majority of such therapies do not cure the disease but it helps companies

EXPRESS PHARMA

May 16-31, 2017

earn good profits. On the other hand, antibiotics which actually cure the disease are priced much lower. In order to preserve the effectiveness of antibiotics used in critical care, they are required to be used judiciously for several years, thereby further curtailing their sales growth. This is unlikely for lifestyle disease products as their sales keep expanding on yearly basis. As a result of Big Pharma exodus from antibiotic discovery, internationally the skill sets required for antibiotic discovery have also sharply declined. On the other hand, scientific challenges involved in discovering novel antibiotics targeted towards multi-drug resistant pathogens have multiplied in view of a superbugsâ&#x20AC;&#x2122; ability to deploy multiple resistance mechanisms. Such a scenario demands discovery of new agents that can tackle a broad range of pathogens and resistance mechanisms. This

such challenges it is no wonder that in the past four to five years several Indian companies that were engaged in this field have also given up discovery efforts.

requires highly specialised skill sets and considerable insights in this therapeutic area, which is developed through longterm commitment. Looking at

DEATHS ATTRIBUTABLE TO AMR EVERY YEAR

What are the challenges faced in formulation of antibiotics and anti-parasitic drugs? As antibiotics have a wide range of uses besides treating infections, including pre and post-surgical propylaxis for a range of surgical procedures, organ transplant, and hip/knee/joint replacement, it is important that the formulations developed are compatible with a wide range of clinical conditions. Development of injectable formulations throws up a significant challenge in managing injection site tolerability. Similarly, oral formulations need to have good GI tolerability and rapid absorption for quick onset of antibacterial action. How much share is allotted to research for AMR in Wockhardt? Wockhardt has been engaged in drug discovery research for the last 20 years and invested significantly during this period. Last year, our spend on R&D itself was approximately 15 per cent of our sales of which our drug discovery portfolio is a critical component.

Source: The Review on Antimicrobial RĂŠsistance, Jim O'Neill, 2016

Wockhardt has recently received an approval for phase III clinical trial from the US FDA, could you brief us about the new superdrug? WCK 5222 is a novel class of

superdrug that introduces the first entirely new class of Gram-negative antibiotic treatment in 35 years. WCK5222 is expected to be a life-saving destination therapy for serious hospital acquired infections (HAIs) such as hospital acquired bacterial pneumonia, ventilator associated pneumonia and blood stream pneumonia and blood stream infections. It would be the first antibiotic moving ahead in Phase III for five gram negative superbugs Enterobacteriaceae, Acinetobacter, ESBLs, Salmonella, Pseudomonas. Wockhardt has five drugs which have entered phase II and phase III clinical trials. What is the progress on these drugs? Our NCEs WCK 771, WCK 2349 and WCK 4873, are against multi-drug resistant gram positive infections, while WCK 4282 and WCK 5222 are against multi-drug resistant gram negative infections. In addition to WCK5222, WCK 771 and WCK 2349 drugs have received QIDP status. Presently, this combination is entering phase III clinical trials in India, post successful completion of its global phase I and India-based phase II trials. It would cater to Indian and emerging markets. Further, WCK 4873 is positioned against multi-drug resistant gram positive superbug and has successfully completed its global phase I trials and would be entering global phase II trials. WCK 4282 is a combination

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‘CHONDRON has been safely... Continued from Page 12 this treatment, the patient can benefit from pain relief, long term restoration of function and smooth and congruent cartilage surface. ◗ The surgery does not include any foreign material ◗ The shelf life is more than 30 years ◗ Rehabilitation can happen in 6-12 weeks, a person can resume professional sports within a span of 6 months ◗ ACI is recognised as a global natural biological solution for cell and tissue regeneration Some of the other advantages of this treatment include: ◗ Improves mobility ◗ Regenerate the damage cartilage tissue ◗ Regain full function ◗ Helpful for professionals/athletes ◗ After three months of cell implantation, you can see new cartilage generation at defect site through X-Ray and MRI.

Will you be partnering public and private hospitals for Chondron? Yes, we will be partnering with all types of hospitals including government, semigovernment, private and military hospitals. We are looking to target cities like Mumbai, Delhi, Bengaluru, Chennai, and Hyderabad, Ahmedabad and Kolkata in phase I and then later plan to target smaller cities. What strategies have you chalked out for commercialising the product? We are looking for external venture capital, private equity funding and also seeking strategic partnerships with hospitals. Are there any new products are in the pipeline and what stage are they in for completion? One new product is in pipeline known as Uregrow which is indicated for urethral stricture patients. We have already

initiated Phase II B clinical trial for this product in India. This is DBT- BIRAC part funded clinical trial. How do you plan to raise funds for capacity expansion and marketing of cell therapy? We will be targeting various government agencies that can provide funds for our innovations and for capacity expansions and we will also be looking at external investor/ private equities, venture capitalists. Presently, company has the capacity to culture 1,000-1,200 patient samples annually. Do you have plans to set up new facilities or expand existing facilities? Yes, we have planned for a new lab facility for the scale up of production/ operations. u.sharma@expressindia.com

Wockhardt... product, effective for gram negative infections untreatable with current main therapies. It would be the first line antibiotic for hospital pathogens, addressing resistant cases due to multi-drug resistant superbugs. It is soon to enter global phase III trials. Which are the other drugs in the pipeline? Wockhardt intends to acquire global leadership in the field of antibiotics. We are focussed on creating a continual stream of well differentiated, novel antibacterial therapies and thus continuously easing the global AMR burden. Other drugs under development are targeting much needed therapeutic options for paediatric, diabetic foot infection patients. mansha.gagneja@expressindia.com

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MARKET PRE EVENT

Express Pharma to host FDD Conclave in Hyderabad Showcasing India's formulation and drug delivery skills, the FDD Conclave is a platform for leading industry professionals to gain the latest learnings, case studies, regulatory insights, and innovative technologies they seek in a rapidly evolving industry segment THE INDIAN Express (P) and Express Pharma, India’s leading pharma business magazine are organising Formulation Development & Drug Delivery Conclave (FDD). To be held on June 16-17, 2017 at the Novotel, Airport in Hyderabad, for the 100+ leading professionals in attendance, this is the platform for the technologies, innovations and applicable insights they seek in a rapidly evolving segment.

Opportunities galore As per the February 2017 IBEF report, India is the largest exporter of formulations in terms

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of volume, with 14 per cent market share and 12th in terms of value. The domestic market is currently valued at $11.2 billion, with double-digit growth expected over the next five years. On the biosimilars side, with an annual growth rate of 30 per cent, the domestic market is expected to scale $40 billion by 2030. Formulation research and development is sure to increase in tandem, with the government planning to allocate $70 million for local players to develop biosimilars. What’s more, Indian pharma companies currently spend 8-11

per cent of total turnover on R&D, and the February IBEF report also predicts an increase in R&D spend, which includes formulation R&D, as players try to differentiate themselves by investing heavily in R&D efforts and the development of new drugs. There is no doubt that drug development and formulation is also a crucial part of India’s drug delivery devices market (estimated at $5.28 billion and expected to touch $14.69 billion by end 2020). Currently dominated by injectables, the sector is also seeing promising work in trans-

dermal, ocular, implantable, oral, nasal, topic and pulmonary drug delivery devices.

Staying ahead of the curve Adding to this is the possibility of tapping new patient segments, creating branding strategies around innovative drug delivery approaches and meeting evolving regulations. Be it in the discovery and development of new, better medicines or improving existing ones, there is clearly a need for the knowledge of executable strategies and leading-edge technologies. Come this June, for the 100+ lead-

ing professionals in attendance, the two day event will help: ◗ Showcase their formulation and drug delivery skills ◗ Gain access to solution providers with cutting edge delivery technologies ◗ Capture leadership insights from formulation research gurus ◗ Present case studies of innovative formulation research and drug delivery projects ◗ Discuss regulatory insights comparing device/product registration in different geographies EP News Bureau

EVENT BRIEF EVENT BRIEF AUGUST TO SEPTEMBER-2017 3

PharmaTech Expo 2017

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. The focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event. Contact details PharmaTechnologyIndex. com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Techn-ology, Government of India. Contact details MMI India INIZIO 507 & 508,

EXPRESS PHARMA

May 16-31, 2017

5 th Floor, Cardinal Gracias Road, Opp P&G building,

India Lab Expo 2017/ analytica Anacon India Chakala, Andheri (E), Mumbai - 400099

Tel : +91 22 42554710 Mob: +91 9820668393

Fax: +91 22 42554719 info@mmi-india.in

MARKET POST EVENT

5 edition of iPHEXconcludes in Hyderabad th

Pharmexcil organises technical seminars Usha Sharma Hyderabad THE 5TH edition of iPHEX (International Pharma and Healthcare Exhibition) recently concluded in Hyderabad. The three-day event was organised by Pharmexcil, under the aegis of Ministry of Commerce, Government of India. KT Rama Rao, Minister for Information Technology, Municipal Administration & Urban Development, Government of Telangana, inaugurated the exhibition. Agyemang-Manu Kwaku, Minister for Health, Government of Ghana was the Guest of Honour. CEOs of top pharma companies also attended the inaugural ceremony. Ravi Udaybhaskar, Director General, Pharmexcil said, “Today, India is largely dependent on China, in respect to intermediates and key starting materials (KSMs) and few APIs. We are 100 per cent dependent on manufacturing some of the intermediates to APIs. If these imports stops abruptly, we are not in a position to manufacture some of the antibiotics which are in the NLEM list and other categories as well. In this connection, we have developed a strategy to reduce the dependency on import from China and we move into a direction to manufacture these intermediates and KSMs to make India self reliant. Pharmexcil for the first time under the guidance of Ministry of Commerce and Industry is closely working with CSIR Labs, Bulk Drugs Manufacturers Association (BDMA) and other research institutes and universities, to create a dialogue between industry and academia.” He further said, “Since the past two to three months, we had meetings with scientists, industry associations like Indian Drug Manufacturers' Association (IDMA), BDMA and other

20 EXPRESS PHARMA May 16-31, 2017

The objective of the seminars were to understand the updated drug regulations in India and overseas countries, awareness about inspection procedures and how to prepare for audits eminent scientists who are heading the industry in their field.” Udaybhaskar also informed that a ‘Think Tank’ has been created which represents members from these associations. Lanka Sriniwas, Senior Advisor, Pharmexcil and Dr Chandra Sekhar, Director IICT have been appointed as the mentors to the 'Think Tank'. Pharmexcil also organised technical conferences on three subjects mainly International Regulations – An Overview and Challenges, International Procurement Practices in Pharmaceuticals and Vaccines and

Strengthening of APIs and Intermediates in-house. The objective of the seminars were to understand the updated drug regulations in India and overseas countries, awareness about inspection procedures and how to prepare for audits. Dr Eswara Reddy, Joint Drug Controller (I) and Dr K Bangarurajan, Dy Drugs Controller (I) made presentations on ‘Regulatory Updates in India’. Senior officials of FDAs of Nigeria, Ghana, Namibia, Ethiopia, Egypt, also made presentations about drug registrations/ regulation procedures of

their respective countries. SM Mudda, Executive Director, Micro Labs, made a presentation on ‘Changing Regulatory Practices and Suggestions for successful audit / inspection. Anand Iyer, UL Enduneering, USA presented his views on audit practices and preparedness – facing audits. Dr Harish Iyer, Senior Advisor, Scientific Programs, Bill & Melinda Gates Foundation made a presentation on ‘Procurement Practices – Ensuring access to Vaccines and ARVs. Venkat Raman, Head-Exports, Bharat Biotech also made a presenta-

tion on ‘International Procurement Practices for Vaccines: Challenges & Opportunities in Exports. Parag Nagarkar, Associate Vice President, Sanofi spoke about ‘International Procurement Practices for vaccines – Regulatory Challenges. Lanka Srinivas, Dr Rakesh Mishra, Director, CCMB, Dr Dinesh Abrol, Secretary General, Delhi Science Forum, Prof Reddanna, Dean, School of Life Sciences, University of Hyderabad, made detailed presentations and actively participated in the panel discussions. Sponsored buyers and exhibitors meetings were organised during the three-day event. Over 550 pharmaceutical buyers, importers, manufacturers, regulators, journalists, associations etc., from 95 countries across the globe attended the event. 290 Indian companies with took part in the event. u.sharma@expressindia.com

cover )

SKILLING UP Skilling has emerged a priority in Indiaâ&#x20AC;&#x2122;s pharma sector with LSSSDC, industry associations and consultants spearheading initiatives in this direction. Yet, are all the pieces needed to plug the gaps in place?

22 EXPRESS PHARMA May 16-31, 2017

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THE MAIN FOCUS

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cover) INSIGHT

Strategies for making high pharmaceutical quality affordable: Part II Dr Ajaz S Hussain, Former Deputy Director Office of Pharmaceutical Science, US FDA, currently Founder of Insight, Advice & Solutions, US and President, National Institute for Pharmaceutical Technology and Education (NIPTE), US, gives an Indian-American and an ex-USFDA leader’s perspective on the current challenges related to cGMP non-compliance and quality of generic drug applications. He urges academia all over the world to work toward a reform of pharmaceutical science and technology education and develop a meaningful certification process for the 21st century

eneric drugs are the most effective means to enhance the affordability of medicines in the US. The Hatch-Waxman Amendments to the FD&C Act achieved a sustainable way to ensure generic drugs would be available immediately following statutory patent protection, and marketing exclusivity for new (or brand) drugs had expired. The affordability (public health) objective was balanced with innovation (public health) objective by providing new (or brand name) drug manufacturers a significant statuary patent protection and a period of marketing exclusivity so that the investment in the development new drugs is recovered. In 2016, the faculty of National Institute of Pharmaceutical Technology (NIPTE) deliberated within and with the US FDA on how to confidently ensure availability of First generic. Also, the collaboration between Sun Academy and NIPTE on Quality by Design Education and Certification was progressed (1). In this report, which builds on Part I published in Express Pharma November 1-15, 2013 (2) , I wish to share with the target audience in India what

24 EXPRESS PHARMA May 16-31, 2017

Back to a discussion on the US context: What does the nation need?

NIPTE (a not-for-profit collaboration among 17 top US University) aims to contribute. Specifically, about New Prior Knowledge (note the oxymoron is by design) and Education with Certification. However, before doing so, I wish to position this discussion in a broader context particularly the on-going discussion in India triggered by Prime Minster Modi ji’s proposal to progress a legal framework which essentially seeks to create an automatic substitution mechanism for generic drugs in India (as in the US).

Generic substitution in India and the questionWho makes the drug? “We will bring in a legal framework by which if a doctor writes a prescription, he has to write in it that it will be enough for patients to buy generic medicine and he need not buy any other medicine,” he [Prime Minister Modi ji] said. Various news reports, April 17, 2017. The ensuing debate in India has just begun. Among the many nuances in this debate, one of the most prominent is the adequacy of regulatory mechanism, and the obligation of Indian physicians to be

assured of the quality; and to gain this confidence why they perceive a need to rely on the ‘reputation’ of companies they believe are committed to quality. Unfortunately, perceptions of quality are not factual true assurance of quality. In principle, this need for assurance was the concluding statement of my 2013 (Part I) report (2): Increasingly patients across the globe will ask the question “who makes the drug I take”; and trust and credibility will be critical. Let’s hope the strategy that reliably makes high-quality, affordable wins! Déjà vu.

About 40 per cent of the generic drugs on the US market are imported from India. Over the past few years significant violations of US cGMPs have been noted at many companies in India. These violations are clear indication to the US consumer that companies are failing to deliver the committed the level of quality assurance. In 2013, Janet Woodcock’s (Director CDER/USFDA) testimony to the US Congress entitled FDA Check Up: Drug Development and Manufacturing Challenges outlined the problem and proposed a strategy.(3) Problem: Use of foreignsourced materials creates vulnerabilities in the US drug supply. Solution: FDA has been working diligently for over a decade, in collaboration with the pharmaceutical industry, to improve drug manufacturing [she was referring to PAT and QbD]. Building on this foundation, and utilising new technologies, groundbreaking new manufacturing methods are within reach [she was re-

ferring to PAT-based realtime controls and continuous manufacturing]. These new ways of making drugs could, with the proper strategies, revitalise pharma manufacturing in the US. On January 28, 2016, Woodcock gave her testimony to the US Congress on the Implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) (4). In it, she (again) highlighted four ongoing challenges. The two challenges most relevant to this discussion include: (i) Quality of the ANDA submissions, and (ii) Need to better assure quality in an increasingly globalised industry. The sustained expression of (her) concern about the quality of generic drugs and its assurance is one of the highest regulatory priorities in the US.

Where are we today with these [PAT and QbD] initiatives? In part I of this report (2013) I had noted - Today, with the active encouragement of the US FDA, there is visible progress in continuous monitoring and manufacturing of pharma API’s and products in an integrated manner. A potential shift in paradigm in the making.

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Where are we today (in 2017)? At the tipping point! Today there is an unprecedented juxtaposition of the main forces, necessary for a domestic [US] pharma manufacturing renaissance: President Trump’s focus on US manufacturing, the progress in pharma technologies such as continuous manufacturing and real-time controls, and legislative recognition of the need for efficient pharma manufacturing as in the 21 st Century Cures Act. Let us not underestimate how exceptional this celestial alignment can be for efficiently catalyzing technologically modern, efficient, and profitable pharma manufacturing in the US (5).

A global stance: Let strategy, that reliably makes high-quality affordable medicines, win At NIPTE, we are passionate about making high-quality affordable medicines for all in need. We take a comprehensive approach. As we pursue developing our programmes, we are building and supporting international efforts. This includes the recognition of the critical contribution India pharma makes. For example, on the topic of continuous manufacturing, I hope to meet many readers of this report in Mumbai at the USP Pharmaceutical Continuous Manufacturing (PCM)—Technology Development and Implementation Workshop (May 16-17 2017) to further discuss the latest development. Although this is not directly an NIPTE effort, it is an effort supported by NIPTE via my participation to facilitate faculty members from University of Rutgers (a NIPTE member) and USP to share exciting information about latest technological development with audience in India.

How can NIPTE help to improve quality of ANDA submissions? New Prior Knowledge: Multiple review cycles and increasing number of Complete Response Letters is a growing concern, not getting it right (the first time) is a symptom. Inadequate time and inability to utilize prior knowledge, in a regulatory system incentivised (rightly so) for ‘file first,’ leads to ‘file first and figure it out later.’ Effective solutions (while maintaining the ‘file first’ to get the ‘first generic’ on time) requires the availability of usable ‘prior knowledge.’ The NIPTE New Prior Knowledge programme is being developed as a solu-

tion to what the nation needs now. Several NIPTE faculty members have begun working to develop this solution. In my report entitled NIPTE 2016: From Roadblocks to Roadmap2017, with a 2020 Vision (1) the concept is explained using case examples. The idea of NIPTE Certification (of the prior knowledge) is conceived as the built-in peer review, challenge, and verification that a multi-university collaboration can muster as part of the translational (research to policy to practice) process. Such certification may take the form of NIPTE Monographs (e.g., Quality Target Product Profile based on analytical characterisation of RLD) that can supplement Compendial monographs. Education and certification: What is the predominant mode of acquiring knowledge about aspects of pharma development and process validation in the regulated industry context, designing effective investigation plans for out of specification observations, establishing QTTP and product specifications, writing SOPs, understanding the correct applicability of pharmacopeias for batch release test, etc.? With very few exceptions, current academic programmes such as pharmacy, pharmaceutics and industrial pharmacy, etc., do not adequately address this need. On-the-job training and experiential or adaptive knowledge acquisition are highly variable. “Experience” is predominantly measured as years on the job; which I propose is not a reliable metric. Therefore, it is expected that there will be considerable heterogeneity in observing, recording, and interpreting cGMP inspection observation; between regulators within the same agency, between regulatory authorities, and, of course, by and within companies. Similarly, there is marked heterogeneity is how we set specification and understand and use pharmacopeias. Education and continuing education programme with meaningful certification (for student, industry and regulatory staff ) are urgently needed (6). The Sun Academy – NIPTE collaboration is one such effort many such efforts are needed (1).

Academia needs to step up: Be the third leg of the stool (1) I wish to conclude this report with a message to the academic communities all over the world. That message is that the gap in what students learn in

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cover ) schools and what they need at work has already become too large. We must catch up and work toward a reform of pharma science and technology education and develop a meaningful certification process for the 21st century. The debate on generic drugs triggered by Prime Minster Modi ji touches upon how automatic substitution without adequate assurance makes people feel; it is personal and profound. In the US, we still have these debates â&#x20AC;&#x201C; today the difference is we want to know which company in India makes the medicine we take. To academicians who will read this - Let us remember how patients think and feel can have a significant impact on the therapeutic outcome. In preparing the next generation of medicine makers let us work together to find ways to also teach

them how they can (activate their mirror neurons) feel the pain of compromised assurance. Assurance is a critical quality attribute with direct impact on safety (nocebo effect) and efficacy (placebo effect). Our families and we need the medicines they will make. Let us secure the assurance fellow humans need and deserve.

References 1. Hussain, A. S. NIPTE 2016: From Roadblocks to Roadmap2017, with a 2020 Vision. https://www.slideshare.net/a2 zpharmsci/from-roadblocksto-roadmap-2017-with-a2020-vision 20 December 2016 2. Hussain, A. S. Strategies for Making High Pharmaceutical Quality Affordable. Express Pharma November 16-30, 2013. (Vol 9, No 1, pages 28-30)

https://issuu.com/indianexpressgroup/docs/ep20131115pages/28 3. Woodcock, J. FDA Check Up: Drug Development and Manufacturing Challenges. Subcommittee on Energy Policy, Health Care and Entitlements Committee on Oversight and Government Reform U.S. House of Representatives. 12 December 2013. http://www.fda.gov/NewsEv-

ents/Testimony/ucm378343.ht m 4. Woodcock, J. Implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) - House Testimony. February 4, 2016. http://www.fda.gov/NewsEvents/Testimony/ucm485057.ht m 5. Hussain, S. A., Gurvich, V. and Pitts, P. How Trump and the FDA Can Create a Pharmaceutical Manufacturing Renaissance. Op-Ed. Morning Consult. 10 April 2017. https://morningconsult.com/o pinions/trump-fda-can-createpharmaceutical-manufacturing-renaissance/ 6. Hussain, A. S. Pharmaceutical Quality Assurance in the 21st Century: A sharper focus needed on education, training, and experience. Express Pharma. (Vol 11, No 4: pages 20-21). May 16-31, 2016 https://issuu.com/indianexpressgroup/docs/ep20160531pages/21

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Quality excellence through skill development SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and Director - Global Strategy (Technical), Micro Labs, emphasises the need to adopt a Quality Management Systems (QMS)-based approach to provide quality medicines

evisiting the question posed in my article 'Pharmaceutical quality and compliance: Has the 'elephant in the boardroomâ&#x20AC;&#x2122; been recognised' in Express Pharma GMP special issue of May 2016, it appears that we have embarked on the quality journey and the industry seems to have corrected its skewed perception related to GMPs. It has recognised the need to go beyond mere ticking the boxes for demonstrating compliance with minimum regulatory standards to adopting a Quality Management Systems (QMS)-based approach and positioning quality as a management function for providing high quality medicines. A myriad of initiatives have been started by the industry and associations that demonstrate a paradigm shift in the approach towards quality and compliance. The focus clearly seems to be on skill upgradation and capacity building. The IPA Quality Forum is working tobring the large companies together to address quality issues and to jointly develop solutions based on global best practices with a view to help Indian pharma manufacturers to achieve global benchmark in quality. Similarly, the Department of Pharmaceutical (DoP), Ministry of Chemicals & Fertilizers has initiated a nationwide GMP training programme in partnership with IDMA for helping the industry to voluntarily upgrade GMP standards to current global standards. One of the major policy initiatives of Government of India of recent times has been the Prime Minister's Skill India initiative implemented through Life Sciences Sector Skill Development Council (LSSSDC) in pharma industry. Despite these initiatives, the industry still confronts operational challenges for ensuring ongoing GMP compliance and in implementing successful remediation measures. The common factor in both the cases seems to be lack of adequate skills

of personnel in these functions as seen from the observations below.

Consistently inconsistent GMP Compliance- A recurring issue Having seen the welcome shift in focus by the industry to make skill development and knowledge management as key enablers for quality excellence, one would have expected companies to achieve a state of sustainable compliance. However, a look at the regulatory actions of the last year and inspection findings point towards the operational challenges the industry is still facing to remain in a state of compliance. While companies heaved a sigh of relief if no data integrity issues were observed during the inspections of the types seen in the previous years, when challenged on what actions were taken by the companies when things went wrong, companies seem to wrestle in meeting the regulatory expectations. The recent examples of Warning Letters issued for not addressing the perennial issues of recurring product complaints adequately for years, underestimating the risk to patient safety and releasing batches with inadequate Corrective and Preventive Actions (CAPAs) or another one related to invalidating a high number of Out of Specification (OOS) results, again without identifying

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cover ) the causes of OOS results, indicate a clear lack of capabilities of the operating personnel and reviewers. Many examples of failure investigations with particular reference to complaints, batch rejections, deviations and out-of-specification results revealed companies building arguments in favour of release of batches rather than identifying the root causes and implementing preventive actions, often due to lack of understanding, ability and occasionally due to lack of commitment. All these failures indicate a QMS that is insufficiently empowered and is not resourced adequately with employees possessing the required skills and capabilities of investigating the failures by adopting a science and risk-based approach.

Underinvestment in talent development during remediation While the challenges for GMP compliance are attributed to inadequate capabilities of key personnel, it has also been one of the major contributing factors for remediation failures. The recurring failures of compliance, despite comprehensive remediation plans implemented point towards correcting the interacting parts (individual functions) of a QMS in isolation rather than building it. Deming’s System of Profound Knowledge (See Fig 1) teaches us to appreciate the organisation as a system-seeing and leading it as a system and not causing people in different departments to compete for attention and resources. System is a product of interacting parts. Improving the parts taken separately will not improve the system. It appears that in the remediation phase, the QMS is developed in response to GMP failures and is focussed only on implementing immediate quickfix measures for short-term gains. The measures of improvements implemented through a weak QMS or outside of QMS do not integrate the CAPAs in the QMS and hence can't sustain the benefits of remediation. During this phase, focus is not given on

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Fig 1. Deming's System of Profound Knowledge

Fig 2

Fig 3

building an appropriate quality organisation with competent key personnel suitable for the size of the organisation and complexity of the operations. The remediation activities are seen to be executed by the team of consultants at the expense of developing local quality leadership. There has been an under investment in the talent needed to upgrade the quality system once the company emerges from the remediation.

Connecting the three dotsGMP, quality system and culture of quality The examples of GMP and remediation failures suggest that the power of quality system as a foundation in creating a sustainable culture of quality has not

been fully realised and QMS is not yet regarded as the philosophy behind the practices and a key driving force for compliance. The development of a QMS that is lean, simple and agile, connecting it to GMPs and using it as a foundation to foster a culture of quality is going to be possible only when the organisations develop second-level leadership for quality (See Fig 2). It is clear that the only way forward for a sustainable compliance is education of the key personnel in the organisations whose actions will be consistent with the top management’s quality intent (policy) in letter and spirit and they will have a capability to convert the intent to concrete action plan for implementation. This view has been

confirmed through various surveys conducted by consulting firms like Ernst & Young and others. A long-term education programme and not training will be a strategic investment in prevention of non-conformances.

LSSSDC provide the Occupational Standards for various functions including quality management. The standards presently are aimed at building the basic capabilities in each function and apply mostly to operating level employees.

IDMA initiative in skill development

IDMA – NSF: An unique collaboration

IDMA understands that in the wake of ever increasing regulatory bar, expectations from technical and QA professionals who represent the company for demonstrating an ongoing compliance with GMPs have increased. Lack of structured formal education of these senior practicing technical/ QA professionals in the concepts of quality management is identified as one of the key factors for failures that requires immediate remediation. Indian Drug Manufacturers’ Association (IDMA) in collaboration with UK-based NSF Health Sciences (formerly known as David Begg Associates) therefore has launched a customised intensive education and skill development programme ‘Advanced Program in Pharmaceutical Quality Management '(APPQM) targeted at Pharma Technical and Quality Assurance Professionals. This education programme that is created after a careful study of the issues faced by the industry with the expert team of NSF, UK over a period of the last two years, will help build the strength of the quality professionals across the industry with a formal certificate of international standards and an ability to match the global professionals. The initiative is the latest in a series of endeavours by IDMA to re-skill senior pharma professionals, in response to the prolonged regulatory woes being faced by some companies in India, stemming from poor GMP compliance. The IDMA initiative is consistent with the objectives of the Prime Minister’s Skill India initiative implemented through LSSSDC. In fact, IDMA is one of the stake holders in the LSSSDC governing body. The qualification packs developed by

NSF International UK is a global leader in education for the pharma industry. IDMA has selected NSF because it has knowledge of the India pharma industry and over 40 years of global experience with offices in India, the US, China, the EU and the UK. Its team of experts includes Martin Lush, Global Vice President, NSF Health Sciences, UK, Robert Hughes, John Johnson, Chris Harris, Dr Peter Gough and Bruce Davis and includes ex regulators (MHRA & FDA) and seasoned professionals with 35 years plus hands on experience. Some of the tutors have been involved in writing key industry standards including ICH Q8, 9, 10 and WHO, EP and USP standards.

Programme details and benefits The APPQM is designed specifically for Indian companies who want to succeed in US and European markets. Designed both as an education and mentorship programme, the intense and challenging MBA style programme will provide participants education related to best industry practices in quality culture, quality management, regulatory compliance, manufacturing operations, leadership skills, skills in risk- based decision making, advanced problem solving, crisis management, simplification and lot more. Delegates will complete a written assessment for each module. Successful candidates will be awarded an internationally recognised certificate in PQM. The course fee for a 30-40 batch, of approximately 8100 GBP + 15 per cent service tax plus actual travel and stay expenses is considerably lighter on the training budgets of pharma companies. This is considerably

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more economical, especially for smaller companies, who do not have the budgets to exclusively hire the faculty for 40 tutor days of in house training, which would come to around 150000 GBP compared to 10000 GBP for the entire programme. Sessions will be highly interactive using problem based learning to change behaviours and improve performance. The programme will be delivered in five intensive modules (See Fig 3). Each of four days duration scheduled every eight weeks. For ease and convenience modules will be presented in Bengaluru at the beautiful campus of Acharya College, Bengaluru.

Return on investment - Improved operational efficiency Clients who have attended NSF programmes have generated $ millions in savings. For example: Reducing repeat deviations by 78 per cent in just six months, reducing ‘Human Error’ deviations by 67 per cent in 12 months, achieving 99 per cent ‘Right First Time’ at product release and achieving zero regulatory observations following audit.

Improving behaviours and ‘quality mind-set’ NSFs methods ensure that learning is taken out of the classroom and into the workplace. Behaviours will change and performance will improve. People stay when they know they are being developed.

Pre-launch of the programme The pre-launch of APPQM was held at Bengaluru on February 12, Hyderabad on February 14 and Mumbai on February 16, 2017. The pre-launch was supported by DoP and FICCI at Bengaluru, PHARMEXCIL at Hyderabad and Fourrts (India) Laboratories and Micro Labs at Mumbai and was attended by more than 120 senior members of the pharma industry along with dignitaries from government and regulatory agency. The presence of senior government officials highlighted the importance and enhanced the value of this programme. Sudhansh Pant, Ministry of Chemicals and Fertilisers, Government of India, at Bengaluru, Uday Bhaskar, DG, Pharmexcil at Hyderabad and Sudhanshu Pandey, IAS, JS, Ministry of Commerce and Industry, Government of India, at Mumbai graced the events. IDMA leadership team comprising board members, SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and the Program Coordinator, lead by the National President Deepnath Roy Chowdhury and immediate Past National President, SV Veerramani, participated in the events. Omprakash Sadhwani, Joint Commis-

sioner FDA, Maharashtra, Mumbai and Dr K Bangarurajan, Deputy Drugs Controller (I), CDSCO, West Zone Mumbai also applauded IDMA for this excellent initiative and for taking training to the next level. IDMA has received 20 confirmations for registration and the seats are filling fast. The response from the companies is very encouraging and interestingly, apart from the technical and QA professionals, the next generation entrepreneurs have also come forward to join the programme. The programme also has received good support from the Qualified Persons (QPs) from UK who oversee the GMP compliance of the Indian sites supplying medicines to the UK and Europe. The first batch is starting tentatively from September 2017.

Conclusion Medicines are only as good as the people involved in making them. It is said that ‘Quality is too important to be left to Quality Controllers alone'. Quality is in fact the responsibility of everyone. Thus, people in R&D, manufacturing, QA, QC and people from functions having direct or indirect impact on the quality of products including the Nextgen business leaders contribute in making the best products and it would only be appropriate that they are educated in the concepts of quality management. We need to understand the difference between training and education. While training can develop skills required for performing tasks well (the how of a practice) education of the concepts behind the practices will develop the ability of people to make the practices consistent and sustainable (The Why of How). The experience of remediation of the last few years has revealed that short-term training programmes do not help in changing behaviours. Similarly, transformation initiatives not supported by concrete action plans and management support do not yield desired results. As Deming exhorted, quality transformation launched by ceremonies with a speech by the governor, raising of flags, beating drum, badges, all with heavy applause, is a delusion and a snare. While such programmes can give an impression of progress being made, in reality unless supported by concrete actions the real benefits will elude us. The answer for skill building lies in providing structured long term, on-going education platform to the industry. Such programmes alone will help in developing Change Agents for Quality Excellence and will make India the centre of excellence for pharma manufacture. The APPQM offered by NSF- IDMA is one such significant first step towards quality excellence and in building “BRAND INDIA”.

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cover)

Building pharma quality: From the top-floor to the shop-floor Vikas Bhadoria, Senior Partner and Vivek Arora, Associate Partner, McKinsey & Company, emphasise on the need to build a strong quality culture, which will lead to superior performance and can build a company’s reputation to world-class levels

uilding and maintaining high-quality products and processes is top priority for CEOs across industries, more so in the pharmaceutical sector where the foremost objective is to ensure patient safety. Qualityrelated events have put several companies in a spot, impacting not only sales and market valuation but also their reputation. Senior managements across companies emphasise that quality is their most important business objective, and highlight it in important internal and external stakeholder interactions. Companies have been making substantial investments in quality including remediation, in order to upgrade technology and infrastructure, build highprofile leadership teams, onboard domain experts and hire more resources. However, non-compliance observations from recent regulatory audits, show issues similar to those flagged twothree years ago. While some of these are technical and relate to product quality and the reliability of standard operating procedures, others indicate gaps in day-to-day activities such as data management, investigations, material management, and other shop floor practices. A closer look suggests that the managements’ efforts have not necessarily translated into mindset and behaviour change at the shop-floor.

30 EXPRESS PHARMA May 16-31, 2017

were six common themes:

Vikas Bhadoria, Senior Partner McKinsey & Company

Only a few have been able to build a quality culture where everyone from the ‘top-floor to shop-floor’ takes ownership of quality and feels responsible for it. This requires shifting deep-rooted mindsets and behaviors which have been built over years. Stepping back from pharma, iconic global companies attribute their inimitability to culture which is lived by everyone in the organisation. Google’s culture of innovation touches all of its employees, some of whom have generated ideas that have transformed the world of technology. Toyota’s culture of lean and continuous improvement makes

McKinsey’s empirical research done jointly with International Society for Pharmaceutic al Engineering has established that culture is one of the biggest contributors to qualityoutcomes in pharma

Low-capability workforce, high attrition and a transactional approach to capability-building: A large portion of operators and analysts do not have the capabilities to keep up with increasing complexity as well as regulatory expectations. Our experience indicates that attrition rates in manufacturing and quality control can go up to 30 per cent. Training is often conducted with a ‘tick the box’ mindset, focussing on compliance needs rather than building technical, functional and behavioural skills required for different roles. Vivek Arora, Associate Partner, McKinsey & Company

strong quality culture have superior performance including fewer lesser product failures.

Demystifying culture

it one of the most efficient and respected manufacturing companies. Quality in pharma is no different. McKinsey’s empirical research done jointly with International Society for Pharmaceutical Engineering (ISPE) has established that culture is one of the biggest contributors to quality-outcomes in pharma. Sites with a

To understand what drives quality culture at pharma plants and corporate organisations, we used a comprehensive approach covering over 25,000 shop-floor workers, supervisors, middle-managers and senior executives. The results were fascinating. Apart from a few company specific nuances, the big cultural gaps were similar for most organisations, varying only in degree of deviation from best practices. There

Limited understanding of best practices and quality: Many shop-floor workers do not comprehend evolving quality guidelines and best practices. They lack understanding of common industry metrics such as ‘out of specification’, ‘out of trend’ and ‘process capability’, or their implications on day-to-day work. Lesser focus on quality vis-à-vis cost and productivity: Our benchmarking of over 700 pharma plants globally, indicates that highrankers on quality, also rank high on cost efficiency and productivity. However, on the shop-floor at some pharma companies, the commonlyheld belief is the opposite. The workers believe that quality

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A very important cadre that needs to change behaviour is that of shop-floor supervisors. With a direct exposure to operators, it is imperative for them to create an open and transparent environment, so the latter feel comfortable about flagging issues. Building supervisory capability also helps improve operatorsâ&#x20AC;&#x2122; day-to-day experience, and hence reduces attrition and productivity are inversely proportional and this feeling could be driven by disproportionate focus on delivering high volumes at low cost. Fear of escalation to supervisors and management: We find that employees, who are closest to the product and machines, are often apprehensive about raising day-to-day quality issues to their seniors. This is either because of the fear of being held responsible, or the burden of getting things back in order. These problems are magnified as managements move away from the shop-floor and senior leaders spend less time solving problems on the ground. Limited collaboration: At the plant level, some organisations do tend to work in silos, with limited interaction between the manufacturing, quality and engineering functions. This inhibits information sharing, as well as the participation in critical investigations that require cross-functional expertise. Management behaviour: Quality is the top agenda in senior management discussions at external forums; yet the same leaders fail to demonstrate similar commitment and focus in their day-to-day behavior and interactions. Topics such as cost reduction and ontime delivery, get higher priority at times at the expense of quality.

Building a culture- What it takes? Our experience of culture transformations across industries, suggests that

more than two-thirds of such attempts do not fully meet the desired results. Organisations often fail to communicate an inspiring change story, and management behaviour is not supportive or does not reflect the change. Other reasons are insufficient allocation of resources, inadequate reinforcing mechanisms, and in some cases the employeeâ&#x20AC;&#x2122;s inability to change. Indian companies including some pharma players who have undertaken the culture-change journey, are trying to address these issues and the six underlying themes mentioned above. Building conviction through the organisation: Aligning on a common goal of quality excellence is the first step in the culture-change journey. Successful companies use a multichannel approach to communicate the change story. This could include setting a quality-focussed vision and communicating that through various physical and digital modes of communication (such as posters, videos), town-hall meetings, shop-floor huddles, visual statements of purpose and smartphone messaging. Some companies have developed cross-functional forums where employees can regularly meet, share their experiences and discuss ways to improve quality. This helps create a broader base of change agents, who are committed to making a difference. Demonstrating quality focus in dayto-day behaviours: Leaders of the organisation need to make behavioural adjustments to ensure they put qual-

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cover ) ity above all else; particularly during interactions on the shop-floor. In management meetings of some companies, quality discussions are slotted ahead of other agenda and chaired directly by the CEO. Senior leaders go on ‘gemba walks’ to demonstrate commitment to quality and identify improvement areas, as well as have conversations with operators, and coach them on ensuring good quality in their work. A very important cadre that needs to change behaviour is that of shop-floor supervisors. With a direct exposure to operators, it is imperative for them to create an open and transparent environment, so the latter feel comfortable about flagging issues. Building supervisory capability also helps improve operators’ day-to-day experience, and hence reduces attrition. Making quality a priority across functions and reinforcing it through cascaded performance dialogues: So that quality is not just the responsibility of the quality-control function, qualityrelated

CULTURE CHANGE MODEL

key performance indices (KPIs) or key result areas (KRAs) need to be shared across all function-particularly those with a direct impact on quality such as manufacturing, R&D, and engineering. Performance di-

alogs covering quality need to start at the shop-floor, and go all the way up to the CEO. With digitisation and automation in use more widely, companies have access to advanced analytics for real-time data monitoring and perform-

ance management. CEOs can monitor quality parameters on a particular machine, in real-time. These systems can create higher awareness of good quality. Empower and enable the

shop-floor to drive change: Organisations need to build capabilities of their workforce. Revamping training and capability-building practices is often an early requirement. In the short-term, workers and supervisors need capability-boosters in critical areas like- conducting high-quality investigations, ensuring sterile manufacturing environments, enforcing data reliability, and general shop-floor cleanliness. In the longer term, the training curricula, particularly for news hires, needs to be redesigned to include not just compliance, but a full suite of technical, managerial and behavioural skills. The training approach needs to evolve from being confined to classrooms. It needs to be multi-channel, experience-led and on-the-job, and with frequent reinforcements. Building a culture of quality is a long journey. One-size does not fit all. Most interventions have a long gestation period and require commitment from the management. But once in place, it can build a company’s performance and reputation to world-class levels.

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Skill level directly impacts quality, which has a direct impact on human life Ranjit Madan, CEO, Life Science Sector Skills Development Council links skill levels in the pharmaceutical sector, quality and safety of medicines, and India's global market share, in an interaction with Viveka Roychowdhury

Sir, as CEO of the Life Science Sector Skills Development Council (LSSSDC), set up under auspices of Ministry of Skill Development, what advice would you like to give the leaders of pharma companies regarding the January 1, 2018 deadline issued by the Drug Controller General of India (DCG(I)? DCG(I) circular of August 26, 2016, which has since been endorsed by various state FDA offices as well, makes it mandatory for all organisations to hire those certified as per standards developed (National Occupation Standards) with inputs

from industry. It also mandates all organisations to have all employees (other than D. Pharma/ B.Pharma/ M.Pharma, for whom this is desirable) assessed. Those clearing need to be certified by LSSSDC; others need to be upskilled through bridging courses which LSSSDC will help provide, or by organisations addressing the shortfalls ‘in house’. Since skill level directly impacts quality, which in life sciences (LS) has a direct impact on human life, criticality of all employees meeting agreed/ defined standards is of critical importance. It will also have a direct bearing on India’s ability to be

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EXPRESS PHARMA

May 16-31, 2017

cover ) a major global player, as also to increase its global market share—where stringent regulations like US FDA and EU are in place. We must also bear in mind that quality of education and ITI certification in India varies greatly. Cost of any errors due to substandard skills at any level, far outweighs all costs incurred to undergo the exercise, be they time, resources including monetary. Finally, to facilitate conducting a skill gap analysis under ‘Recognition of Prior Learning’ (RPL) programme of GoI, we have organised for all assessments of employees of small scale sector (below ` 150 crores turnover) to be free of cost under PMKVY (Pradhan Mantri Kaushal Vikas Yojana). Which are the pharma companies which have shown interest in partnering with LSSSDC to expand skilling activity in life sciences sector? We have thus far received complete details of employees to be assessed under the nine major job roles which are currently our focus, from 27 companies. Of these, and in line with schedule provided by the companies, over 3000 employees from about 20 companies would have been assessed by end April. We have also received advice in writing for 9000+ employees to be assessed in coming months. Prominent companies that have thus far registered data/ interest in writing with us include Abbott, Akums, AstraZeneca, BiologicalE, Cadila, Claris Otsuka, DRL, DSM, GVK Bio, Mankind, Morpen, NecLife, Panacea Biotech, Reckitt Benckiser, Wockhardt, apart from SMEs. More companies are establishing contact with us on a daily basis. What are the crucial areas where the pharma sector

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Quality of education and ITI certification in India varies greatly. Cost of any errors due to substandard skills at any level, far outweighs all costs incurred to undergo the exercise, be they time, resources including monetary. An entire skilling eco system is in place and skilling activity has already been triggered. We now look to industry to help scale up the activity, and seek state government help to, in tandem, mobilise suitable candidates needs to build up skills? All areas are crucial and skill shortfalls exist in all. In due course, as the exercise gains further momentum, we would have a much clearer picture of the extent of challenge i.e. by size of organisation, by job roles, by cluster etc. At this point though, and as agreed with Ministry of Health and Family Welfare and CDSCO team, our focus is on the major nine job roles: Manufacturing AssistantLife Sciences, Packaging Assistant – Life Sciences, Production/ Machine Operator, Fitter MechanicalLife Sciences, Production Chemist, Maintenance Assistant- Life Sciences, Production Supervisors, Packaging Supervisor Machine/ Manual- Life Sciences and QC Chemist, which comprise over 50 per cent of job volume in manufacturing and QC. Has the skill gap scenario improved since the Skill Gap Study conducted by LSSSDC in 2014 with KPMG? The Skill Gap report (or base report) highlighted the job roles and clusters which we need to focus on to address the skill gap challenge in the sector. We have, since then: ◗ Developed with industry input, National Occupation Standards for 61 major job roles that comprise

90 per cent of total job volume of sector. Six of these have also been mapped with UK standards, and we now have ‘transnational standards’ in place for these six, for future use ◗ Developed, with Industry input, curriculum and content for the major 10 job roles that cover almost 70 per cent of total job volume of sector ◗ Accredited over 70+ training partners ◗ Conducted 36 ‘Train the Trainer’ programmes, certifying 326 trainers—with help of ‘Master Trainers’ nominated by major industry partners ◗ Certified close to 15000 candidates for various verticals To sum up, an entire skilling eco system is in place and skilling activity has already been triggered. We now look to industry to help scale up the activity, and seek state government help to, in tandem, mobilise suitable candidates. Who are the other stakeholders, besides pharma companies, who need to be part of this skilling initiative? The sector currently employees approximately 800,000 in about 10,000 units, 90 per cent of which are in small and unorganised sector — where we are mandated to conduct a skill

gap analysis and help bridge any gaps. Further, we need to skill candidates for meeting demand of fresh hires. Together, over a 10 year period, the target is of the order of 2.1 million. This a huge challenge. The most critical stakeholder is of course the industry. Also very important is the academia, which includes colleges, universities and schools—especially those located in the five major clusters of LS activity viz. Baddi in HP, Hyderabad and Visakhapatnam in Telengana/AP, Bengaluru in Karnataka, Gujarat and Maharashtra. This is so that the youth in such belts desirous of finding meaningful livelihood in this sector, can be skilled (with practical training) and get employed in industry located in the respective clusters. Role of state government is also very crucial—specially in creating awareness amongst the youth in the respective states and in helping mobilise suitable candidates What are LSSSDC’s strategies to meet its goals of helping to generate a sustained stream of high quality skilled individuals, approximately 2.1 million in number— over 10 years? ◗ As shared, we are sharply focused—first targeting the most voluminous job roles in

the major clusters of life sciences activity ◗ Realising that quality directly impacts human life in the sector, all our decisions are driven with this being the foremost parameter ◗ Industry involvement at each stage of skilling chain is vital, since it is the organisations that are hiring those certified. Inclusivity is the key. Today we can proudly state that practically all of the top 30 companies are involved closely with us, and we continue to forge partnerships with more and more organisations. Crucially we are forging strong connect also with small scale units which are such an important constituent in the sector. It’s worth highlighting that major organisations such as Cadila, Wockhardt, Granules have either accredited their ‘in house training’ facilities with LSSSDC or joined hands in skilling; others are expected to follow ◗ Skilling is being imparted by enlisting support of industry so that practical training is imparted on the shop floor or lab of industry, considering the high capex of equipment required for skilling. In this, we will continue to leverage our strong connect with industry associations, all of who are represented on our governing body, and entities such as CII ◗ Convergence with our line, Ministry (Ministry of Health & Family Welfare and DCG(I) office is critical to success of the initiative. The fact that DCG(I) has issued a circular shows the strong faith that they have reposed in us and our activitities ◗ With aim to leveraging technology to make the system as efficient as possible, e.g we are aiming to make available digitised assessment, effective July 2017 viveka.r@expressindia.com

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‘Regulatory compliance at the shop floor is a key gap that needs to be bridged’ Hemant Deshpande, Managing Partner, Pollux Life Science Solutions, in an interaction with Viveka Roychowdhury, elaborates on the skill gap between academia and industry and how Pollux's three level skilling programme, ‘Emerge – A success Elevator’ will help bridge this gap

By your estimates, where are the most crucial skill gaps in the Indian pharmaceutical / life sciences sector today? In Indian context, the exclusive focus during academic sessions is on conceptual knowledge without much reference to the application of the concepts and its relevance in business environment as is the practice in developed countries. To put it in simplistic terms, it is like training a driver of a car or a pilot of an aircraft on a simulator and putting him on job without internship or finishing school. On the other hand, the industry expects the application of the concepts, thorough understanding of the process, dos and dont’s about handling of equipment identification and handling the exceptions. To my mind, the most crucial and significant gap in Indian pharmaceutical / life sciences sector today is at the manufacturing stage loaded with critical regulatory compliance. Needless to say, with maximum US FDA approved manufacturing plants outside the US being in India, we have the benefit of carrot by way of remunerative revenue but also face the stick during regulatory inspections for a solitary error made in isolation by a fresh or relatively young pharmacy

The fact of the matter remains that a large percentage of student fraternity are inclined towards securing employment rather than a well thought career selection. A part of this blame can be attributed to academia for not undertaking the qualitative counselling process beyond the quantitative academic marks and entrance tests. The absence of counselling results in mid-career crisis, saturation etc as also leads to high job hopping and attrition rate. Moreover, the entire economic burden of moulding the raw talent into a skill-full job-ready professional over a period through trial and error falls on the industry.

entrant at the shop floor. In revenue terms, this not only impacts the image of the company and industry but also the country as destination. I think regulatory compliance at the shop floor is a key gap that needs to be bridged by equipping the staff with skills among several others. While, skill gap between the academia and industry has always been a subject of a

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frequent debate, it has only received the necessary attention after Life Science Sector Skill Development Council (LSSSDC) incubated by Ministry of Skill Development stepped in. How is this impacting the prospects of both the industry as well as professionals who have chosen to make their careers in this sector?

The DCG(I) has mandated that by January 1, 2018, ‘no person shall be employed in any pharmaceutical/biopharmaceutical manufacturing units unless he has obtained a formal diploma or degree in the relevant area, or has been certified by the LSSSDC or equivalent organisation in the area in which he is deployed.’ How are companies strategising to get on track to meet this deadline? Industry response has always been a peculiar one, waiting for someone else to make the first move. The notice by DCG(I) was issued in August

2016 and the industry took some time to understand the implications as also the practical issues involved in compliance. Having said that, in the past couple of months the industry through its cluster organisations -- OPPI and IDMA -- had series of meetings with LSSSDC to evolve a joint coordinated action on the subject. On its part, LSSSDC has also issued guidelines and FAQ’s for easy understanding of the industry. Pollux Life Science Solutions has been given the mandate by LSSSDC to conduct broad-based skilling courses for the pharma industry. What job profiles will these training courses cater to? Can they be customised, tailored as in house training modules for individual companies? Pollux has been affiliated for four job roles for Mumbai and Pune centres: quality control chemist, quality assurance chemist, manufacturing chemist and medical sales representative. In the next few months, by June end, Pollux plans to add five more roles (drug regulatory affairs, clinical research, lab technician, manufacturing assistant, maintenance assistant) and expand its reach to Nashik, Aurangabad, Nagpur, Goa and Daman. Thus Pollux has planned to

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cover ) reach out to the western region with a large basket of roles, which will cover about 90 per cent of the overall job functions in the pharma industry. Although LSSSDC has defined a specific pattern and curriculum for each job role training, we at Pollux have kept a flexibility of incorporating the additional training modules as per customer needs. What has been the response so far, in terms of which companies, how many individuals have attended or signed on for these courses, etc? How many such courses have already been conducted and where? The industry has responded cautiously but with some element of enthusiasm on the prospect of getting much better trained, skilled and

employable resource from the skills development project. Around 15 companies in Mumbai have responded and shown inclination to enter an arrangement with Pollux. We plan to enter into a formal MoU with these companies by start of June 2017. The LSSSDC skills development is covered under a specially designed programme of Pollux called ‘Emerge – A success Elevator’ which is a three level build up. The first two levels include a comprehensive understanding of pharma industry, career options and guidance. It is ideally suited and designed for the undergraduates of science and pharmacy as the objective is to facilitate them to select a career of liking and choice within the pharma chain. The third level is the LSSSDC skills training for the

graduates and for a specific role. The training includes class room and practical understanding through internship with pharma companies. The first batch of all four roles in Mumbai and Pune is planned from May 15, 2017, immediately after the annual exams conclude. What will be the cost per course, module? Who will be bearing the cost, the employee or employer? The affiliation of Pollux as a training partner of LSSSDC is in open category which means it does not include the funding under Pradhan Mantri Kaushal Vikas Yojana (PMKVY). Hence, the cost to the students for each job role would be in the range of `15,000-20,000 which is around three to four per cent of their total costs in acquiring the formal degree.

In order to cater to a vast pool of aspiring students belonging to economically weaker sections, Pollux is contemplating to obtain affiliation under PMKVY to ensure that these sections of students are not deprived of quality learning due to lack of resources. The pharma industry in general and companies have the option to sponsor such students as part of their corporate social responsibility and in turn get a well-trained human resource. On its part, Pollux offers a wide range of options to employers, starting from hiring the trained resource at a nominal cost to participating in the process right from initial screening of the students, providing internship and absorbing the trained resource based on vacancies and credentials of the candidate.

This year’s budget allocated ` 2,200 crore ($ 325 million) for the next phase of the Skill Strengthening for Industrial Value Enhancement (STRIVE) initiative. Can employers access these funds to meet the DCG(I)'s mandate? If so, what is the process? As I understand, the compliance of DCG(I) mandate is called Recognition of Possessed Learning (RPL). At the initial stage, the assessment process is free of cost to those companies with annual turnover less than ` 150 crores. I believe that such companies can get advantage of the budget allocation to some extent, though we are also seeking clarity on the same. viveka.r@expressindia.com

I N T E R V I E W

‘NSF's education courses, like the APPQM, change the way people think’ Medicines are only as good as the people making them, points out Martin Lush, Global Vice President, Pharma Biotech and Medical Devices, NSF Health Sciences. In an email interaction with Viveka Roychowdhury, he explains how the NSF-IDMA ‘Advanced Program in Pharmaceutical Quality Management (APPQM) will provide companies with ‘rounded’ professionals who will help senior management sleep easier at night What does the NSF certification mark mean to the pharma and biotech industries? NSF was established in 1947 to improve global health. It is an internationally recognised, respected and trusted certifying body. What does this mean for the Indian pharma

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biotech industry and those attending NSF IDMA APPQM? It means those who pass the course's assessments have met the standards required and have the knowledge to improve their companies’ regulatory compliance, competitive advantage and reduce risk.

What are the services NSF International provides to this sector? Our objective is to leave clients better off than when we found them. More profitable, more compliant and more resilient (future proofed). Our services include consultancy support, benchmarking, education,

auditing and remediation. But with a difference. Our education courses, like the APPQM, change the way people think. Our auditing and consultancy services help simplify operations to improve efficiency as well as compliance. And when clients get into trouble with

regulatory agencies our remediation services leave our clients stronger, not weaker. We just treat our clients in the way we would like to be treated. With humility and respect. NSF International's staff is a mix of former regulatory

( agency staff and experienced industry professionals and in fact provides training to regulators from eight regulatory agencies, including agencies in the US and the EU. Can you give us a sense of how this unique edge translates into consulting, course content and classroom insights, etc. for your clients in the pharma sector? We handpick our team based on two things. Character and experience. The NSF team have a character that is caring and totally committed to our clients. Most have 30+ years ‘hands on’ experience across the product lifecycle. From research through to manufacturing and quality assurance. Some are world experts in their field. All are inspirational leaders, mentors and course tutors. This unique blend of leadership experience, industry knowledge and technical/scientific expertise provide students with a unique learning opportunity. As part of the APPQM, programme delegates will be assigned a personal course tutor. This 1:1 mentorship programme will accelerate delegates personal and professional development and create life long friendships As Global Vice President of Pharma Biotech and Medical Devices for NSF International, what is your perspective on the fact that for the past two years, pharma companies in India are the subject of many warning letters indicating decreasing GMP compliance? India is the number one supplier of generic medicines in the world so it’s not surprising it gets a lot of regulatory attention, including a growing percentage of Warning Letters. In the main these are due to failure to translate GMP requirements from the paper (policies and SOPs) into practice on the shop floor. We must remember, medicines are only

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There is an acute shortage of experienced and knowledgeable people globally. Not just in India. This shortage is costing our industry billions of dollars weekly because of one thing. Poor decision making

as good as the people making them. The APPQM course will provide delegates with not just the technical knowledge needed, but the leadership skills to inspire and motivate others to follow the rules. Many companies have also been criticised for not adopting modern concepts of Quality Management and manufacturing practices. Those attending the APPQM course will learn the very latest thinking and best industry practices across the product life cycle. How critical is the shortage of skilled staff in this sector in India? What is the global trend on this aspect? There is an acute shortage of experienced and knowledgeable people globally. Not just in India. This shortage is costing our industry billions

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of dollars weekly because of one thing. Poor decision making. To make the right decision you must understand the science as well as the technical aspects of the manufacturing process. You also need to understand the GMP requirements, possess excellent risk based decision making skills and have the ability to influence others. This is what makes the APPQM so unique. We will blend all of these skills and requirements together to produce world class pharma professionals. Delegates attending the APPQM will get the equivalent of 10 years’ experience and knowledge condensed into just five modules. That’s what you call fast track development! Having worked in several pharmaceutical

manufacturing firms, holding senior leadership positions in the areas of quality assurance, quality control, development, supply chain, corporate auditing and governance, what is your take on the role of senior management in GMP compliance? We all know that quality culture and GMP compliance starts at the top. Not by their ‘words’ but by their actions and behaviours. However, having worked in senior positions myself I know how busy and distracted leaders are. They can’t do everything. They can’t be everywhere. They must have people they can trust to ensure compliance standards are maintained, risks minimised and efficiencies improved. The APPQM will do just that. Provide

companies with ‘rounded’ professionals capable of making the right decisions to improve profitability and improve compliance. Professionals who will help senior management sleep easier at night! What are the advantages of the IDMA NSF course over other programmes? The APPQM is unique in many ways. Firstly, the course tutors are world class experts with global knowledge and experience. Secondly, the residential format means delegates remain totally focussed during sessions including the 1:1 mentoring, another unique characteristic. Thirdly, delegates will learn by doing. Case studies, problem solving, discussions and debates will all ensure learning is embedded. Not forgotten. Another unique characteristic is that delegates will have access to NSF’s vast library of free resources as well as its subject matter experts. We also support our delegates outside the classroom. We will also establish an APPQM Alumni group to ensure delegates continue to develop and improve after completing the APPQM. Though not a residential course, a facility for stay could be offered for the convenience of delegates. Wouldn't this add to the cost per attendee? For the reasons discussed above. The residential format is very cost effective because the quality of the learning is gravely improved. For people to learn they must be having fun. In our experience the residential setting creates an environment where delegates learn from each other as well as from the course tutors. Its all about creating an environment conducive to excellent learning. viveka.r@expressindia.com

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MANAGEMENT

FOCUS: INTERNATIONAL CLINICAL TRIALS DAY

THE RIGHT BALANCE? The release of the Schedule Y amendment on January 20, 2005 and the CDSCO notice dated October 5, 2016 about the ‘SUGAM’ portal for online applications for clinical trials bookend a decade of regulatory churn in India's clinical trials sector. Do the regulations finally meet everyone's wish list? As we mark International Clinical Trials Day on May 20, Express Pharma invited stakeholders to crystal gaze into the future and make a wish list of how the sector should develop in the next few years

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INSIGHT

What more for clinical research in India? Dr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR),emphasises on the importance of clinical trials in drug development and recommends measures to create an ecosystem conducive for good quality, ethical clinical research in India THE LAST few years have been a transformative one for clinical research in India. Important regulatory changes have led to a more supportive environment for conducting research. Many of the challenges in regulations and guidelines have been addressed. Overall, there has been a positive shift in people's attitudes and perceptions about clinical trials but, given the huge disease burden India carries, a lot more remains to be done. In the larger context of Indiaâ&#x20AC;&#x2122;s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 17 per cent of the worldâ&#x20AC;&#x2122;s population and 20 per cent of the global disease burden and yet, less than 1.4 per cent of global trials take place in India. Hence, it is imperative for us to introduce new drugs in the country to address the unmet medical needs of our patients. And since clinical research is the cornerstone of the drug development process, while we need to have rules which protect the rights, safety and well-being of the patients that participate in research, at the same time we need to ensure that the ease of doing business is a reality for conducting good quality, ethical clinical research in India. Several positive measures have been introduced by clinical research regulators in the last few years to facilitate the discovery of new treatments for Indian patients. Today, clinical research regulations in India are more balanced and the pendulum that had earlier swung to an extreme is gradually moving towards the centre. The application and ap-

While clinical research in India has not reached its ultimate desirable state, we are headed in the right direction for facilitating drug development in India to meet the unmet medical needs of our patients proval process flows are more well-defined, making the process for clinical trial applicants easier. Timelines for providing approvals have also been defined by the regulators, which has made the environment for research a lot more stable and predictable compared to the period of uncertainty we saw between 2013-2015. Steps such as online submission of clinical trials, making minutes of Subject Expert Committee and Technical Committee meetings available online, etc. have led to increased transparency. The regulators have been very forthcoming in soliciting and implementing feedback received from various stakeholders about the steps that need to be introduced to create a more balanced and scientific framework for con-

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ducting quality clinical research in India. While we have made significant progress, there are certain areas that still need to be addressed for India to realise its true research potential. For instance, the functioning of the Subject Expert Committee (SEC) needs to be made uniform and the protocols should be reviewed in a standardised manner. This will help remove the subjectivity in the review process and will serve as a guide to SEC members as well as sponsors on how a study protocol will be evaluated. While the approval timeline has significantly improved as compared to 2013, there is scope to improve it further. The current approval timeline of six months provided by the regulators still does not provide India

the competitive edge it needs when it comes to global drug development. Bringing it down even further to three months will really benefit our country and there are ways to achieve this without compromising on patient safety. Not all trials should be required to pass through the three-tiered approval process comprising of a review by the SEC, Technical Committee, and the Apex Committee. There needs to be welldefined criteria for identifying the types of clinical trials that need to be approved by all the three committees in addition to a review by the CDSCO, and defining the types of clinical trials that will require fewer levels of review and approvals. Additionally, the committee meetings should be conducted regularly at

pre-defined frequent intervals to expedite the reviews. There is a need for better clarity on the accreditation process of Ethics Committees that is intended to take effect from January 1, 2018. Timelines and roles need to be defined for the various steps in the accreditation process in terms of what exactly will be done, how it will be done, when it will be done and by whom it will be done. Absence of clarity and well-defined timelines could lead to confusion and errors in implementation. For implementing the accreditation process, an incubation period of at least three years ideally should be provided so that the entire machinery is geared up for operation at the end of the three years. Even at its peak, India was conducting less than two per cent of all global clinical trials. For a country the size of India with a huge burden of unmet medical needs this definitely needs to increase by several folds. The regulators will need to continue addressing the areas of concerns and, at the same time, let the outside world know how processes have been made easier in India to facilitate clinical research. This will augur well with our governmentâ&#x20AC;&#x2122;s theme of Make in India. While clinical research in India has not reached its ultimate desirable state, we are headed in the right direction for facilitating drug development in India to meet the unmet medical needs of our patients. India has excellent scientific talent, as well as the necessary infrastructure to conduct good quality clinical research in adherence with national and international regulations and guidelines to keep patients safe while discovering newer treatments. We all need to work together to make this a reality.

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MANAGEMENT

Quality with a supersized Q Naz Haji, SVP and Managing Director, QuintilesIMS India, elaborates on the need to improve awareness amongst the Indian public about the role and relevance of clinical research and their rights and responsibilities as patients BETWEEN 2012 and 2015, clinical research in India was at its nadir. Hit by regulations and guidelines, clinical research in the country had reached its lowest point and was virtually at a standstill. Global sponsors pulled clinical research out of India, while Indian sponsors chose to place their trials in neighbouring countries which offered a more predictable and secure regulatory environment. The most impacted in all of this were patients for many of whom participation in a clinical trial was their only access to a lifesaving opportunity. Delayed or halted clinical trials also meant more that patients who were waiting in hope of new and more effective treatment would either have no access or delayed access to the latest treatment. Fortunately, if anything, events of the past brought clinical research stakeholders in India together on a collaborative platform to deliberate over what needed to be done to restore normalcy in the clinical research regulatory environment. Meetings were held, arguments put forth and discussed and, slowly but surely, not only were new regulations introduced but corrections were made in existing regulations and guidelines to ensure that we had a strong regulatory environment in place which was patient-centric and focussed on safety and ethics. While there are still areas that need to be addressed, we are now at a stage where clinical trials are starting to come back to India. It may not be at the same pace as what was anticipated but then restoring trust and confidence is a slow process and will take time, notwithstanding the fact that in a clinical trial, decisions are not made overnight.

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As the clinical research ecosystem in the country emerges from its dark shadows to take on the challenges of a new regulatory environment, there is renewed interest amongst global stakeholders in India. There is one area above all that we need to focus on and it is quality, with a supersized Q. While data from global clinical research inspections validates the high quality of clinical research being done in India (source: ISCR), any findings around data integrity or quality could cause serious reputation damage and set the industry back several years. It is imperative therefore for all stakeholders to be conscious, more than ever before, of the need to ensure that quality is paramount in all that we do, even if it means

giving in more than a 100 per cent. Dr W Edwards Deming, the father of the quality revolution, talked of quality being everyone's responsibility and the need for everybody in the company to work towards accomplishing this transformation. In our business, we need to extend the ‘company’ to include the entire spectrum of clinical research stakeholders. Quality is the responsibility of each and every one of us and we need to work together to ensure that we are seen as a country that is committed to and delivers clinical research of exceptional quality. We owe this to our patients. With the second largest global population and the world’s highest disease burden, India faces a

‘triple burden’ caused by communicable diseases, non-communicable diseases and sociobehavioral illnesses. We struggle with diseases that are close to being eradicated in other regions – such as cholera, tuberculosis, and measles – and at the same time must contend with rising rates of cancer, diabetes, cardiovascular ailments and other typically Western illnesses as a result of increasing incomes, changing lifestyles and an ageing population. Yet less than 1.4 per cent of global clinical trials are carried out in India. We also owe it to our sponsors. Given the billions of dollars it costs to bring a new drug to market, any quality oversight will not just add additional time and cost to the drug development process, but it could jeopardise the future of a promising molecule. We have to ensure that the conduct of clinical research and the data we submit from India does not give any sponsor or regulatory authority cause for concern. It is a responsibility that we constantly remind ourselves of within our organisation, which is why quality is a continuous focus and commitment. Over and above, the need for an enhanced quality culture, there are other areas that we need to address. There is a need to improve awareness amongst the Indian public about the role and relevance of clinical research and their rights and responsibilities as patients. Additional investment in capacity building and infrastructure will contribute to better governance and management of clinical research, helping to further advance patient safety and protection. This will further build trust

and confidence among worldwide stakeholders. We also need to encourage more research and development among domestic biopharma companies, and teaching and academic institutions. It is heartening to see Indian regulators committed to build an increasingly balanced and scientific framework for clinical research. A major milestone was the pledge in 2015 from India’s Drug Controller General, Dr GN Singh, that his objectives included “streamlining regulatory procedures without compromising patient safety.” This was further confirmed by Singh’s statement in a business publication in July 2016 which stated, “I can tell you with certainty that India is ready to do extremely good work in clinical trials now. We have created a platform through which India will become a preferred destination for clinical trials. In the next eight to 10 years, our contribution to the global clinical trial industry should be at least 10 per cent.” For biopharma companies seeking a cost-effective location with ready access to patients, expertise and experienced site leadership, India may well be a land of opportunity for bringing new therapies to patients. But for this to happen, we need to ensure that we build a strong culture of quality and that quality is recognised as an intrinsic part of our clinical research offering. This requires commitment and effort for as William A Foster said, “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.”

RESEARCH UPDATES

AstraZeneca immunotherapy wins first approval in bladder cancer The drug, which will have the brand name Imfinzi, works by helping the body’s immune cells kill cancer, offering an alternative to toxic chemotherapy US REGULATORS have approved AstraZeneca’s key immunotherapy drug durvalumab as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of dollars. The approval, while expected, marks a milestone for the British company, which expects new cancer drugs to help revive its fortunes following patent losses on older blockbuster products like cholesterol pill Crestor and Nexium for heartburn. Bladder cancer itself is a relatively small initial market, where AstraZeneca is lagging behind rivals Bristol-Myers Squibb and Roche whose immunotherapies are already approved for the condition. Durvalumab’s big commercial opportunity lies in previously untreated lung cancer, where key clinical trial results, including with combination therapy, are due in June or July. Leerink analyst Seamus

Fernandez sees durvalumab capturing a modest 10 per cent of the estimated $2.3 billion global bladder cancer market, while AstraZeneca in 2014 put the drug's peak sales in all cancers at $6.5 billion, including combination use. The US Food and Drug Administration ( US FDA) said it

granted accelerated approval to AstraZeneca’s drug to treat advanced bladder cancer in patients whose disease had progressed despite chemotherapy. The drug, which will have the brand name Imfinzi, works by helping the body's immune cells kill cancer, offering an alternative to toxic

chemotherapy. While not without side effects, such immuno-oncology treatment has the potential of longer-lasting efficacy, although it comes at a high price. AstraZeneca said the average wholesale acquisition cost of durvalumab would be around $15,000 a month. “This first approval for Imfinzi is an important milestone in our return to growth,” said Pascal Soriot, CEO, AstraZeneca. The drug belongs to a new class of medicines called PDL1 inhibitors that block a mechanism tumors use to evade detection from the immune system. It was approved by the FDA for use in patients with locally advanced or metastatic urothelial carcinoma, by far the most common form of bladder cancer, regardless of their status for the amount of PD-L1 protein on their cancer cells. Durvalumab won accelerated approval, which enables the use of therapies for seri-

ous conditions to fill an unmet medical need based on data the FDA believes is likely to predict a clinical benefit. AstraZeneca is required to conduct trials to confirm actual benefit to patients. The FDA also approved a complementary diagnostic from Roche that can be used with the drug to assess PD-L1 levels. Studies have shown patients with high PD-L1 are more likely to do well on durvalumab, although such a test is not required for its use. Durvalumab is being tested on its own and also in combination with another immune system-boosting therapy called tremelimumab in various cancers. The medicine is the latest immunotherapy to be approved by the FDA, after nods for treatments developed against various cancers by Bristol-Myers Squibb, Merck & Co, Roche, and a collaboration between Germany’s Merck and Pfizer. Reuters

Lilly reports positive interim data on breast cancer combo drug Lilly intends to begin global submissions of these results in the third quarter of 2017 ELI LILLY and Co said the combination of its experimental breast cancer drug and a commonly used treatment met the main goal of a latestage study in an interim analysis, setting the stage for a regulatory submission later this year. Lilly's drug, abemaciclib, is

likely to compete with market leader Pfizer's Ibrance, which brought in $2.1 billion in 2016 sales, and Novartis' newly approved Kisqali. "This is an unexpected win for Lilly," Leerink analyst Seamus Fernandez said, adding that most investors expected the trial to go to completion at

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its planned final analysis at the end of this year. The study, named Monarch-3, compared combined use of abemaciclib and an aromatase inhibitor with the aromatase inhibitor alone. The interim analysis of the combination therapy showed statistically significant im-

provement in slowing disease progression in patients and was deemed as having the 'potential to be best in class,' the company said. In March, Lilly said abemaciclib cleared another latestage study. With positive news following close on the heels of last

month's news, Lilly is assured of a product label with the same breadth as its rivals, Bernstein analyst Tim Anderson said in a client note. Lilly said it intends to begin global submissions of these results in the third quarter of 2017. Reuters

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RESEARCH

Polluting nanoparticles get into blood and damage hearts: Study Nanoparticles tend to build up in damaged blood vessels of people who already suffer from coronary heart disease and make it worse INHALED nanoparticles like those pumped out in vehicle exhausts can work their way through the lungs and into the bloodstream where they can raise the risk of heart attack and stroke, scientists said. In experiments using harmless ultra-fine particles of gold, the scientists were able for the first time to track how such nanoparticles are breathed in, pass through the lungs and then gain access to the blood. Most worryingly, the researchers said at a briefing in London, the nanoparticles tend to build up in damaged blood vessels of people who already suffer from coronary heart disease — the condition that causes heart attacks — and make it worse. “There is no doubt that air pollution is a killer, and this

study brings us a step closer to solving the mystery of how air pollution damages our cardiovascular health,” said Jeremy Pearson, a professor and Associate Medical Director, British Heart Foundation charity, which part-funded the study.

Experts have long known that air pollution carries serious health risks and can trigger fatal heart attacks and strokes. According to the World Health Organization, outdoor air pollution in both cities and rural areas was estimated to cause

3.0 million premature deaths worldwide in 2012. But until now, scientists had not been sure how particles inhaled into the lungs go on to affect heart health. The new findings, published on Wednesday in the journal ACS Nano, build on previous evidence and show that particles in the air we breathe get into blood and are carried to many different parts of the body, including arteries, blood vessels and the heart “If reactive particles like those in air pollution reach susceptible areas of the body then even (a) small number of particles might have serious consequences,” said Mark Miller, a senior research scientist at the University of Edinburgh, who led the study. Miller’s team used specialist techniques to track harmless

gold nanoparticles breathed in by volunteers. They found the nanoparticles can migrate from the lungs into the bloodstream within 24 hours and are still detectable three months later. The researchers also analysed surgically removed plaques from people at high risk of stroke and found that the nanoparticles tended to accumulate in the fatty plaques that grow inside blood vessels and cause heart attacks and strokes. Nicholas Mills, a professor of cardiology who also worked on the study, said the findings showed the importance of cutting emissions and limiting peoples’ exposure to nanoparticles. Reuters

Novartis to speed up bid for MS drug approval, changes target With BAF312, Basel-based Novartis aims to join its rival Roche in developing a lucrative new drug to treat MS NOVARTIS WILL accelerate its bid to win approval for its experimental multiple sclerosis (MS) drug BAF312 and said it was now targeting patients at an earlier stage of the neurological disease. With BAF312, Basel-based Novartis aims to join its rival Roche in developing a lucrative new drug to treat MS. Novartis plans to file BAF312 for approval with the US Food and Drug Administration in the first half of 2018 for patients with relapsing/remitting MS (RRMS), a form of the disease where patients suffer clearly defined attacks. The drugmaker previously said it would seek regulatory approval in 2019 for the drug to treat secondary progressive MS (SPMS) in patients whose RRMS enters a new phase of progressive worsening of function, irrespective

42 EXPRESS PHARMA May 16-31, 2017

of relapses. Novartis said this change approach was appropriate because SPMS was a

continuation of RRMS, in a disease area that defies strict diagnostic categories. Vas Narasimhan, Chief Drug Devel-

oper, Novartis said, he would seek to convince the FDA to take into account characteristics of SPMS patients involved in the Novartis trial when the regulator decides how and to whom to prescribe BAF312. "The best path forward is to pursue RRMS and try to clearly describe the unique population (we) studied in the indication statement and in the clinical trials section," Narasimhan told analysts on a call. Last month, Roche secured FDA approval for its Ocrevus drug to be used against both RRMS and primary progressive MS (PPMS) in which patients' neurological function deteriorates steadily. Reuters

PHARMA TECHNOLOGY REVIEW I N T E R V I E W

Connecting diabetes care to the Internet of Things New connected health technologies can boost medication adherence with smartphone apps and gamification. Heino Lennartz, Vice President and General Manager Global Pharma, West Pharmaceutical Services reveals more in an interaction with Viveka Roychowdhury

What is the impact of missed medication and irregular monitoring for a diabetic? How does this impact disease progression, both from a medical treatment as well as economic burden perspective? Medication adherence in the management of diabetes and other chronic conditions is a complicated puzzle, but one that has to be solved in order to help protect patients from potentially devastating consequences. For example, if left untreated, diabetes leads to high cholesterol and hypertension, which in turn can trigger other complications including stroke, heart disease and even trouble with memory and vision. While research indicates that a patient’s improved medication adherence is directly linked to favourable treatment outcomes for a variety of chronic conditions, including multiple sclerosis and diabetes, patient compliance with chronic medication therapies is remarkably low. In fact, the World Health Organization estimates it at 50 per cent internationally.i In addition to poor clinical outcomes, this non-compliance can mean lost revenue for pharmaceutical companies worldwide (some estimates put this loss at $564 billion globally) and increased costs for many healthcare financial stakeholders, including the patients themselves. What kind of features are

being explored to improve patient adherence and monitoring? For patients with chronic conditions, self-injection systems can provide newfound freedom to self-manage their diseases outside of traditional healthcare settings, like the doctor’s office or clinic. To account for this trend, selfinjection systems must be designed with a patient-centric focus. For example, West Pharmaceutical Services’ SmartDose platform was developed with extensive human factors testing to address potential obstacles to compliance: ◗ Improved patient comfort: The SmartDose platform was designed to maximise comfort throughout the drug delivery process thanks to the hidden 29 gauge needle featured in the automatic needle protection design that prevents accidental needle injuries. Upon safely completing the injection, SmartDose can be easily removed. ◗ Discreteness: Many patients prefer a delivery mechanism that is not visible to others. Special consideration was taken with the SmartDose platform to ensure that it is easily concealed to avoid calling undue attention to the system, creating distractions to others or feelings of stigmatisation for the patient. ◗ Ease of use: Because injectable medications are administered completely by the patient with the SmartDose platform, the process needed to

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designed to offer immediate feedback via a dose confirmation window and visual and audible cues indicating whether the prescribed medication was delivered.

be so intuitive that only minimal instruction is required. To this end, the SmartDose platform currently permits the patient to load the cartridge containing the drug. A userfriendly activation button on the front of the device and LED indicator let the patient know that the dose delivery is in progress. ◗ Dose notification: A critical aspect of the SmartDose platform is its patient-focussed design elements that address the possibility that a user did not receive the full dose, or did not receive their medication at all. To account for these possibilities, the device is equipped with a microprocessor that is

What are the advantages of deploying IoT (Internet of Things) to improve monitoring and patient adherence, in general and specifically in diabetes? We see bright prospects for diabetes care through connected self-injection systems and wearable injectors. For example, connected health systems may offer new options for doctors and nurses who need to confirm the patients are following home medication regimens. New connected health technologies can boost medication adherence with smartphone apps and gamification, which has been studied in diabetes treatment. By incorporating the power of a smartphone app with an integrated wearable drug delivery system, there is an opportunity to improve and reward medication adherence with unique gamification technologies that not only capture when and how much of a medication was taken, but incentivise self-treatment with rewards. Doing so creates a patient-friendly injector that allows for system configurations that not long ago seemed part of the distant future.

Are any such products on the market and are there studies that show improved outcomes for IoT monitoring, gamification apps, etc? To help address barriers to adherence, West collaborated with HealthPrize Technologies to develop a connected health offering that is designed to improve and reward medication adherence with unique technologies in a gamified environment. As a concept, gamification has made inroads in online marketing by applying elements of game playing, such as scoring points, competing with others, setting a hierarchy of rules and, of course, reaping rewards for success. But it is showing promise in other sectors as well, including fitness and healthcare, helping patients find a new way to meet the daily challenges managing diabetes and other chronic conditions. According to HealthPrize data, adherence increased 57 per cent among patients using the HealthPrize app in a study of diabetic medication usage. West is a specialist in containment and delivery solutions, so what kind of collaborations are necessary to incorporate features like IoT and gamification apps? The West and HealthPrize offering integrates HealthPrize’s Software-as-aService (SaaS) medication adherence and patient Continued on Page 44

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PHARMA TECHNOLOGY REVIEW Connecting diabetes...

VENDOR NEWS

Sanner achieves increase in annual sales Sanner plans to consistently expand its portfolio for capsules and desiccant packaging WITH 63.7 million euros in 2016, Sanner has achieved an increase in annual sales. The company strengthened its position as a provider of high-quality plastic packaging and components for pharmaceutical, medical and healthcare products with significant domestic and international investments, the expansion of the product portfolio, as well as efficient development services for customer specific products such as the Atmo Guard System and the newly introduced Sanner IDP-Process. “Once again, 2016 was a very successful year for us. Compared to the previous year, we were able to increase our total turnover by 6.9 per cent, thus exceeding the 60 million euro mark,” says Dirk Mähr, MD, Sanner. “This continuous growth, as well as the numerous developments and investments show that we are well prepared for the future", says Ralf Tiemann, MD, Sanner Kunshan China. Investments included an exchange of most machines for Sanner products in Bensheim, Germany. “The increase in automation and the acquisition of new production machines contribute to an increase in capacity and efficiency,” says Mähr. In the coming years, Sanner will consistently expand its portfolio for capsules and desiccant packaging. The company has also strengthened

the range of services and developments of customer-specific products with the Sanner Atmo Guard System and the IDPProcess , which was recently introduced at Pharmapack Europe. The IDPProcess meets the growing need for customised, holistic packaging concepts for pharmaceuticals and medical devices. Customers

receive individual packaging solutions which is suited for large-scale serial production, while fulfilling all technical and regulatory demands. The expansion of the cleanroom capacities in Kunshan, China, focussed on efficiency and product safety. Since February 2017, 200 additional square metres of production space are available at the site. However, Sanner does not rest on its laurels: “The past years’ successful business results and our excellent future prospects in Asia will require continuous capacity expansions over the coming years,” says Tiemann. Upon completion of the second construction phase at the end of the first halfyear, the company will be able to produce in 2,700 square metres of cleanroom space. A great deal has also happened at the production site in Hungary: on one hand, new employees could be recruited to strengthen the team. On the other hand, the sites in Bensheim and Budapest are cooperating more closely to establish a broader platform for future growth projects in Europe. "With these numerous portfolio and capacity expansions, we are sustainably investing in the future of our production sites," Dirk Mähr summarises. "This way, Sanner is well positioned for further growth." EP News Bureau

Continued from Page 43 engagement platform into injectable drug delivery systems with an app that tracks and rewards patients for taking their medication. This type of rewardsbased patient motivation and engagement can be tied into delivery system training regimens as well. In the first offering from West and HealthPrize, patients will manually scan barcodes or otherwise enter data about their medication compliance into a smartphone/tablet app, or on an Internet browser from a computer if they don’t have a wireless device. In the near future, app use will be even more automated, streamlined and interactive. For example, drug delivery systems or packaging will be able to signal a smartphone to confirm, in real time, that a particular dose was used, the syringe safety system was deployed, all the medication was injected and other details. By leveraging connected health in chronic disease management, including incorporating apps and other systems that add positivity or ‘gamify’ treatment regimens into integrated drug delivery, patients will have new motivation for caring for themselves, in both incentive and accountability, and clinicians will be able to better monitor patient data and medication adherence. viveka.r @expressindia.com

Reference i. http://www.who.int/chp/knowledge/ publications/adherence_Section1.pdf

Deutsche Beteiligungs sells Romaco Group to Truking Group Romaco’s new ownership structure strengthens its position on international markets CHINA’S TRUKING Group is set to become the new owner of the Romaco Group. The relevant contracts were signed recently by Deutsche Beteiligungs and the Truking Group. Deutsche Beteiligungs sold 75.1 per cent of its shares in the Romaco Group to the Chinese Truking Group (Truking), an engineering company which is majority owned by its founder and has already floated part of its shares on the stock market. The remaining shares of DBAG will be sold over the next three

44 EXPRESS PHARMA May 16-31, 2017

years. The transaction is still subject to regulatory approval. DBAG board member D. Rolf Scheffels commented, “The sale successfully implements a buy and build concept which we had worked out with management at the very beginning of our involvement. DBAG, in its role as a Romaco Group shareholder, played a key part in supporting the strategic development of the corporate group and made a decisive contribution to strengthening Romaco’s world-

wide position. In Truking, we have found a buyer that wants to invest in the Group’s global expansion and to further enhance Romaco’s pharmaceutical profile.” Yue Tang, Chairman, Truking emphasised, “We are confident that the acquisition of Romaco represents a win-win situation for all the parties concerned. Romaco will benefit from the change in ownership through an increased share of the Chinese market and Truking will also be able to exploit

outstanding opportunities for growth on European and transatlantic markets.” Paulo Alexandre, CEO, Romaco Group said, “We have held very positive talks with the new owners regarding the future of the Romaco Group and we are confident that Truking is the right partner to pursue our Group’s internal and external growth. The product portfolio and the regional strengths of both companies complement each other very well without any overlapping.

There are also attractive growth opportunities for Romaco in China.” “Romaco will continue to have a completely free hand to pursue its business objectives. This autonomy includes the entire value chain, from product development through to customer service. Work will simultaneously continue on developing the importance of the Romaco Group’s recognised global brands.” EP News Bureau

PHARMA TECHNOLOGY REVIEW

Innovative drug delivery platform relies on Telos reagent chips The drug delivery system offers controlled release using self-cleaving linkers to attach the drug to hydrogel microsphere carriers TELOS 2 Reagent Chips from Dolomite Microfluidics have helped San Francisco-based ProLynx to develop a novel drug delivery platform. Jeff Henise, Director of Process Development, ProLynx, explained, “Traditional polymer encapsulation delivery systems rely on diffusion or

breakdown of the polymer to release their payload. In contrast, our drug delivery system offers controlled release using self-cleaving linkers to attach the drug to hydrogel microsphere carriers. Drug release and subsequent gel degradation depend only on the cleavage rate of the linker,

and are tunable across a wide range. A key part of our manufacturing process is the production of the hydrogel as microspheres, which is carried out using Telos 2 Reagent Chips.” Henise further added, “To produce microspheres of the correct size, we use a mi-

crofluidics approach and a custom-made Telos chip with a 50 micrometer channel. This chip is robust, with excellent chemical compatibility, and offers a high throughput for its size. Although there are other ways of making emulsions, microfluidics offers better control of particle size and

a high yield of monodisperse emulsion. As the resulting material does not need to be screened to remove incorrectly-sized particles, this minimises waste and increases yield by as much as 30 per cent.” EP News Bureau

PRODUCTS

Gandhi Automations’high speed self repairing door meets high standards GANDHI AUTOMATIONS manufactures doors of the highest quality that meet the issue for greater flexibility desired by clients. Prime reset is a unique high speed self-repairing door with the latest technology that prevents downtime of the door system. In case the curtain is impacted accidentally it will cause the curtain to move out of the guides without damage. The movement of the door is designed in such a way it can be recovered with a simple opening and closing operation. High speed self-repairing door in PVC is the most suitable solution in the field industries. It lowers the time of transition from one facility to another, avoiding any human error which can cause damage to the high speed door and all this thanks to the innovative anti crash system. Gandhi Automations provides a world class product with great security.

◗ Innovative anti-crash system ◗ Can be equipped with PVC vision windows ◗ Self-lubricating maintenance free guide ◗ Smooth and silent opening and closing ◗ Protects traction unit, enables rapid wiring and safety photocell ◗ Flexible curtain in self-extinguishing material ◗ Self-resetting without intervention ◗ Quickly back to operation ◗ Control panel designed for an intensive continuous service

The features of self-repairing high speed doors offered by

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Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West) Mumbai – 400064, India. Off: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: http://geapl.co.in/high-speedself-repairing-doors.html

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PHARMA TECHNOLOGY REVIEW

Bosch Packaging Technology displays Industry 4.0 solutions at interpack 2017 BOSCH PACKAGING Technology recently displayed how industry 4.0 solutions provide higher efficiency in modern manufacturing at interpack 2017. For instance, efficient and correct format changes with all format parts reliably installed in the right position, are a prerequisite for low downtime. In the future, machine operators will receive valuable support thanks to the Format Part Management based on RFID technology. The format parts are identified through an RFID tag. Via the format part ID, operators receive relevant information about the format change. This not only reduces changeover times, it also prevents potential mistakes. With the Maintenance Support System (MSS), operators and maintenance engineers are supported in the efficient execution of all kinds of maintenance activities. Thanks to the analysis of machine data in real-time, they receive all required information to their mobile devices. This enables them to react quickly, reduce walking distances and save time for the search for spare parts. The Operations Assistant makes it possible to create and store step-by-step instructions including text, images and videos. Via the visualisation app Maintenance Assistant, operators receive real-time information and instructions for upcoming maintenance and cleaning jobs. In case they do require external help, experienced Bosch specialists can connect with customer machines via the safe VPN data connection of the Remote Service. Whether support for set-up, remote diagnosis, troubleshooting or the installation of software updates is required â&#x20AC;&#x201C; Remote Service makes it possible to correct

46 EXPRESS PHARMA May 16-31, 2017

faults efficiently before they lead to production disruptions. Additional images, videos and audio files can be exchanged with the Shopfloor Remote Assistant. For example, if a spare part needs changing, the Bosch technician can highlight it on the image. Moreover, Bosch offers data-based services allowing Bosch experts to evaluate and

analyse production data and to make recommendations for action. Operators want to be informed about the condition of their lines at any time. The line dashboard provides a clear visualisation of all relevant parameters. Wherever the operators are, the line dashboard delivers the appropriate information including alarm notifi-

cation in case of a defect. This helps to reduce walking distances and downtime. With developments in augmented and virtual reality, Bosch takes transparency and efficiency one step further, and showcased first application areas at interpack. On the mandrel wheel machine PME 4081, Bosch demonstrates how employees

could perform maintenance activities even faster thanks to Augmented Reality (AR). To do so, they receive step-bystep instructions on their tablet, consisting of real machine images, as well as detailed visual and textual information. This way even service staff without expert knowledge can remedy faults and carry out format changes quickly and reliably. AR glasses further speed up this process: instructions are projected directly into the field of view, so that operators have both hands available for the format change. This not only results in an efficient and correct execution of the task. It also brings a welcome change to daily work, as well as a positive user experience. New AR applications also make troubleshooting a lot more efficient. In case of a malfunction, the operator is shown the exact position of the component on his tablet, enabling him to locate and correct the defect faster. Thanks to Virtual Reality (VR), operators can view the virtual image of their real machine, for instance via a smartphone which is integrated into a pair of glasses. VR applications especially facilitate error location and troubleshooting. They can, however, also be used for virtual trainings, such as learning about format changes under near real-life conditions. Trainers can view the simulation live and give supporting instructions immediately. For operators, this is an efficient and safe way of training, as faults have no direct consequences. Moreover, the production process does not need to be interrupted. Contact details Bernd Vierling Phone: +49 711 811- 57165

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The leading air management solution provider... Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects. Airtech undertakes complete project management comprisig of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems. Airtech’s Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clan room applications. EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS 502 & 503, 5th Floor, Satellite Silver, Andheri - Kurla Road, Marol Naka, Andheri (East), Mumbai – 400 059. Tel:+91 9322218023 / +91 9324644630 /+91 9699626434 /+912228592275 E-mail : sales@airtechsys.in, sunil.airtech@gmail.com • Website : www.airtechsys.in

s which lidation service Airtech offers Va otocols pr PQ , IQ, OQ & comply with DQ rnational te In ng wi llo fo conforming to Field Projects) : Standards (Green

•WHO cGMP •US FDA •UK MHRA •AUS TGA •South Africa MCC

With high performance comes design freedom. A choice of 9 RAL colors to go with your brand image.

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

9 RAL colors available

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

May 16-31, 2017

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EXPRESS PHARMA Experiment With The Truth Certified ISO 9001: 2008

A BENCHMARK FOR

QUALITY SOLUTIONS

STABILITY CHAMBER

WALK-IN STABILITY CHAMBER

AUTOCLAVE-WINGNUT

PRODUCT RANGE l l l l l l

Autoclave BOD Incubator Bacteriological Incubator Cooling Incubator Deep Freezer Hot Air Oven

l l l l l l

Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber

Osworld Scientific Equipments Pvt. Ltd.

B.O.D INCUBATOR

B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com

Wiper Type Sight Glass

www. a. ldindi oswor com

DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

Our other product details u

SS Fittings

SS Valves Manual & Pneumatic

SS Filters

SS Pumps: Centrifugal, Self Priming & Shear Pump

SS Powder Blender

SS Steam & Water Mixing Station

Drain Trap

Manhole Round Dia 450

May 16-31, 2017

Sight Glass Flange with LED

LED Bush

4W / 15W / 20W / 24W

Manhole Pressure Type

Manhole Elliptical

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LABORATORY EQUIPMENTS

Lab Stirrers Hot Plate Magnetic Stirrers

Walk-in chamber

Refrigerated Centrifuge Deep freezer

Single Door Refrigerator

Laboratory Centrifuge

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com

OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

May 16-31, 2017

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EXPRESS PHARMA To Advertise in

Business Avenues Please Contact: ■

Mumbai: Rajesh Bhatkal 09821313017

■

Ahmedabad: Nirav Mistry 09586424033 ■

Delhi: Ambuj Kumar 09999070900

■

Chennai ■ Bangalore: Mathen Mathew 09840826366

■

Hyderabad: Mujahid 09849039936 ■

Kolkata: Ajanta 09831182580

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EXPRESS PHARMA Group Companies:

KILITCH HEALTHCARE LLP

NBZ

NBZ PHARMA LTD.

Manufacturing Facilities Accrediation: n n n

WHO GMP Approved ISO-9001:2015, 14001:2015 Certified OHSAS-18001:2007 Certified

Manufacturing Sections: n n n n

Small volume parenterals (Ampoule, Vials) Three Piece Ophthalmic Preservative Free Ophthalmic filling Prefilled Syring

Divisions: n n

Ophthalmic Division Export Division

Head Office: Kilitch Healthcare LLP, 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai â&#x20AC;&#x201C; 400022. Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957

Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701. Tel. : 022 2769 9174, 6516 2146 Mr. Krishnakant Yajurvedi : +91 7710040409

www.kilitchhealthcare.com

www.eyekarekilitch.com

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info@kilitchhealthcare.com

info@ekl.kilitchhealthcare.com

May 16-31, 2017

PHARMA LIFE AWARDS

Sun Pharma Science Foundation recognises Indian scientists and young research scholars Science Award winners announced for exemplary contribution and research in pharma and medical science

un Pharma Science Foundation announced the winners of Sun Pharma Science Awards given to Indian scientists for their outstanding work and exemplary contribution in pharma and medical research. These Science Awards are presented in two categories - The Sun Pharma Research Awards for outstanding scientists and Sun Pharma Science Scholar Awards for young researchers. The winners for both these award are identified in two subcategories - Medical Sciences and Pharmaceutical Sciences. A panel comprising well-known scientists from India selected the final winners. These Awards are presented annually to Indian scientists & young researchers working in India and abroad. Jagat Prakash Nadda, Union Minister of Health & Family Welfare, Government of India was the Guest of Honour at the Sun Pharma Science Awards ceremony in New Delhi.

The awards were presented to all winners by Prof Mike Turner, Head- Infection and Immunobiology, Wellcome Trust UK. The list of recipients of Sun Pharma Science Foundation awards are as follows:

Sun Pharma Science Scholar Award Winners for 2016 Bio-medical sciences award winner Venkateswara Rao Amara — PhD scholar, Dept of Pharmacology & Toxicology, National Institute of Pharmaceutical Education and Research, Punjab, India Rashi Arora — Senior Research Fellow, Dr BR Ambedkar Center for Biomedical Research, Delhi, India

Pharmaceutical Sciences Award Supriya V Vartak Graduate — Student, Department of Biochemistry, Indian Institute of Science, Bangalore

Medical Sciences – Basic Research Award Winner Prof Subrata Sinha — Director, National Brain Research Centre, Gurgaon, Haryana Prof Debabrata Dash — Professor, Department of Biochemistry, Institute of Medical Sciences, Varanasi Dr Virender S Sangwan — Dr Paul Dubord Chair in Cornea, TejKohli Cornea Institute; Director, Center for Ocular Regeneration (CORE); Director, Srujana-Center for Innovation; LV Prasad Eye Institute, Hyderabad

Pharmaceutical Sciences Award Winner Dr Anil Koul — Director, CSIR - Institute of Microbial technology (IMTECH), Chandigarh, Punjab

Sun Pharma Science Scholar Award Winners For 2015 Bio-Medical Sciences Award Winner

Kirtimaan Syal — Molecular Biophysics Unit, Indian Institute of Science, Bangalore, Karnataka Deepali Joon — PhD Student (SPM Fellow), Dr BR Ambedkar Center for Biomedical Research, Delhi

covery of “Polyketide Quinones” in Mycobacterium tuberculosis (Mtb), the causative agent of Tuberculosis (TB) in humans

Pharmaceutical Sciences Award Winner

Prof (Dr) Akhil C Banerjea — Staff-Scientist VII, Professor, Laboratory of Virology, National Institute of Immunology, New Delhi

Sumit Arora — Department of Pharmaceutics, National Institute of Pharmaceutical, Education and Research (NIPER), Mohali, Haryana Sarwar Beg — UGC Meritorious Research Fellow in Science, University Institute of Pharmaceutical Sciences, Chandigarh, Punjab

Sun Pharma Research Award Winners For 2014 Medical Sciences – Basic Research Award Winner Dr Rajesh S Gokhale — Staff Scientist VII, National Institute of Immunology, New Delhi Dr Rajesh S Gokhale is known for his pioneering dis-

Medical SciencesMedical Research Award Winner

Medical Sciences- Clinical Research Award Winner Dr Patrick S Kamath Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, US

Pharmaceutical Sciences Award Winner Dr Ram Vishwakarma Director, CSIR - Indian Institute of Integrative Medicine, (Council of Scientific and Industrial Research), Jammu. EP News Bureau

Kiran Mazumdar-Shaw felicitated with AWSM Award for Excellence 2017 The 6th Annual AWSM Awards were hosted by a wing of The Feinstein Institute for Medical Research,US KIRAN MAZUMDAR-SHAW, CMD of Biocon, has been felicitated with the AWSM Award for Excellence 2017 by the Advancing Women in Science and Medicine (AWSM) wing of The Feinstein Institute for Medical Research, US.

68 EXPRESS PHARMA May 16-31, 2017

Mazumdar-Shaw received the award at the 6th Annual AWSM Awards held in New York City, on May 4, for the impact she has made as an entrepreneur and humanist to healthcare globally and for serving as a role model for

women in medicine and science. Speaking on the occasion, Mazumdar-Shaw said, “I am honoured to receive the ‘AWSM Award for Excellence 2017’ and consider it a great privilege to be in the company

of inspiring women scientists who have made deep and path-breaking contributions in the field of science and medicine. I thank the Feinstein Institute’s Advancing Women in Science and Medicine (AWSM) organisation for

this award and dedicate it to the thousands of women scientists all around the world who are working passionately to make a difference to global health.” EP News Bureau

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