PROGRAM AND SCHEDULE OF EVENTS Mehdi, Additional Professor, PGI, Chandigarh Assuring Quality in...

INTERNATIONAL CONFERENCE OF PHARMACOECONOMICS AND OUTCOMES RESEARCH

VENUE:India Habitat Centre,

Jacaranda HallLodhi Road, New Delhi - 110003, India

rd th23 & 24 November 2012

PROGRAM ANDSCHEDULE OF EVENTS

WELCOME MESSAGE

On behalf of the organizing committee the Society for Pharmaeoeeonomics and Outcomes Research India (SPOR-India) Chapter invites you to the First International Conference to be held on 23rd & 24th November 2012 at India Habitat Centre, Jacaranda Hall, Lodhi Road, New Delhi - 110003, India with a mission to provide an environment for knowledge sharing among researchers, healthcare practitioners and decision-makers interested in Pharmacoeconomics and Outcomes Research.

Moving forward , innovation, speed to market, and cost effectiveness will remain key factors in the life cycle management of pharmaceuticals, medical device s, biotechnology and related products. SPaR will look forward to further hone these areas by providing a comprehensive portfolio of educational opportunities and knowled ge exchange, bringing together industry, academia, government, and people from the community or across the globe.

SPOR-India is making efforts to bring together Indian researchers, health care practitioners, decision makers and members of pharmaceutical industry, health related organizations, academia. It is a resource at a local level for the individuals including students interested in pharmacoeconomics and outcomes research . It provide s an opportunity for India Chapter members to become more familiar with the activitie s of ISPOR as well as participate in its activities. A special session has been kept for the students to present their research workduring podium and oral presentations.

thDelhi has a rich historical background and was continuously inhabited since 6 Century BC. It was a capital of variou s kingdom s and empires. Various monuments of historical importance are found in and around Delhi. Red Fort, Jama Masjid, Qutub Minar, Jantar Mantar, Tombs of royal personage are some of the most alluring monuments. Delhi is a beautiful blend of old and modem architecture. India Gate, Rashtrapati Bhawan , Akshardham temple, Rajghat, beautiful gardens and amusement parks are daily visited by several visitors. Taj Mahal, wonder of the world is situated 200kms from Delhi.

We are looking forward for your active participation in making this conference a great success.

Professor S. K. GuptaPresident, ISPOR India Chapter

Professor S. K. GuptaPresident, ISPOR India Chapter

From the Desk of Organising Chairman

International Conference of

Pharmacoeconomics and Outcomes Researchrd th23 & 24 November 2012

Venue:India Habitat Centre, Jacaranda Hall

Lodhi Road, New Delhi - 110003, India

Chief GuestPadma Shri Prof. Ranjit Roy Chaudhury

National Professor of Pharmacology (NAMS)Adviser - Department of Health and Family Welfare, Govt. of NCTD

Chairman - Task Force for Research, AHERF

Guests of Honor

Dr G N Singh,Drugs Controller General (India),

Secretary-cum-Scientific Director, IPC, Ghaziabad, Min. of Health & Family Welfare

Dr G J Samathanam,Advisor and Head, TDT,

Department of Science & Technology, Govt. of India

Dr Surinder Singh,Director, National Institute of Biologicals, Noida

Min. of Health & Family Welfare

Registrationrd 23 November 2012 8.00 AM – 5.00PMth24 November 2012 8.00AM – 5.00PM

rdInauguration- 23 November 20129.00 AM Onwards

Dr S K GuptaOrganizing Chairman

President , ISPOR-India Chapter

International Conference of Pharmacoeconomics and Outcomes

Research

New Delhi, India

Scientific Program 23rd November 2012

10.40 AM Value Based Pricing – New Trend in Health Technology Assessments

Petr Hajek, Director, Outcomes Research, Pfizer Inc, Czech Republic

11.00 AM Health Technology Assessments - International Perspectives

Simu Thomas, Executive Director, Global Head, Health Economics Modeling, Novartis Pharmaceuticals Corporation, USA

11.20 AM The Recent Status of HTA Development in Asia

Shanlian Hu, Professor of Health Economics, School of Public Health, Fudan University, Director of Health Director of Pharmacoeconomic Management Training Center, and Evaluation and Research Center, ChinaShanghai,

11.40 AM HTA Importance in the EU Member States and Countries on the List to Join

Vladmir Zah, ZRx Outcomes Research Inc., Canada

12.00 AM Health Technology Assessment in Developing Countries

Robert Plisko, CEO, HTA Consulting ul. Starowiúlna, Poland

12.20 – 1.20 PM SYMPOSIUM I

Pharmacoeconomics And Pharmacoepidemiology Chairpersons – Dr J S Bapna and Dr Chandrasekhar Potkar

10.00-10.20 AM Key Note Address:

“Overview of Indian Pharmaceutical Industry” Dr Surinder Singh, Director, National Institute of Biologicals, Former DCGI

Chairpersons – Dr R R Chaudhury and Dr G N Singh

PLENARY SESSION

Health Technology Assessment (HTA) For Better Healthcare Chairpersons – Dr S K Gupta, Dr Petr Hajek and Dr Simu Thomas

10.40 AM-12.20 PM

10.20 – 10.40 AM Coffee Break

12.20 PM Clinical Trials in India: Moving to Qual-economics?

Arun Bhatt, President, Clininvent Research, Mumbai

2.00 PM

2.15 PM

2.30 PM

2.00–2.45 PM

3.00–4.40 PM

3.00 PM

3.20 PM

3.40 PM

4.00 PM

4.20 PM

2.45 – 3.00 PM

Universal Access to Medicines

Sakthivel Selvaraj, Health Economist, Public Health Foundation of India (PHFI), New Delhi

Universal Access of Generic Quality Medicines: WHO Perspective

Madhur Gupta, Technical Officer, WHO (India), New Delhi

Access to Medicines Rajasthan Model

Nirmal Gurbani, Professor, Indian Institute of Health Management Research, Jaipur

SYMPOSIUM II

Strategies For Improving Access To Essential Medicines Chairpersons – Dr Nilima Kshirsagar and Dr Sanjiv Saxena

SYMPOSIUM III Preserving Antibiotics For Future Generations

Chairpersons – Dr Anita Kotwani and Dr Kathleen Holloway

Coffee Break

Kathleen Holloway, Regional Advisor, WHO, SEARO

Cecilia Stålsby Lun

Antibiotic Overuse in India: Recommendations for

Anita Kotwani, Associate Professor, Dep

Nilima Kshirsagar, National Chair Clinical Pharmacology, ICMR Govt. of India,

Dean, ESI-PGIMSR Govt. of India, MGM Hospital, Mumbai

Antibiotic Policy of Ind

Nupur Gupta, Consultant, GDDIC, National Centre for Disease Control,

Promoting Rational Use of Antibiotics– Global and Regional Perspectives

Information and Interventions Needed to Preserve Antibiotics for Future Generations

dborg, Professor, Dept of Public Health Sciences, Karolinska Institute, Sweden

Action

t of Pharmacology, V P Chest Institute,

ICMR Training Programs on Antibiotic Stewardship and Outcomes Research

ia: Challenges Ahead

Delhi

University of Delhi, Delhi

12.40 PM The Importance of Pharmacoepidemiology in Pharmacoeconomical Studies

S E Gulmez, Assoc. Prof., INSERM CIC-P 0005, Pharmaco-epidemiologie,

Service de Pharmacologie, Universiti de Bordeaux, France

1.00 PM Role of Pharmacoeconomics in Health Policy

Munish Duvedi, Clinical Research Associate II, Pharmanet - i3, Gurgaon

Take your discussions further & build new relationships in a relaxed informal setting……….

1.20–2.00 PM Networking Luncheon

Scientific Program 24th November 2012

11.20 - 1.20 PM

9.30 AM SynriamTM New Age Cure for Malaria: Bench to Bedside

Sudershan Arora, President, R&D, Ranbaxy Laboratories Ltd., Gurgaon

10.05 AM Stem Cell Therapy for Cardiovascular Diseases

Balram Airan, Professor & Head CTVS and Chief, Cardiothoracic Centre, AIIMS, New Delhi

10.25 AM Innate Immunity Proteins as Therapeutic Agents against Bacterial Infections

T P Singh, Distinguished Biotechnology Professor, Department of Biophysics,

10.45 AM Towards Enhanced Clinical Development for India’s Needs

Satish Bhatia, Consultant, Clinical Development Services Agency, Dept. of Biotechnology, Govt. of India, Gurgaon

9.30-10.45 AM SYMPOSIUM V

Drug Development & Stem Cell Therapy Chairpersons – Dr T P Singh and Dr S S Agrawal

11.05 – 11.20 AM

SYMPOSIUM CUM WORKSHOP ON Pharmacoeconomics & Systematic Reviews

Chairpersons – Dr Divya Mishra and Dr K K Sharma

Coffee Break

4.00-5.00PM

Podium and Poster Presentations (P1-P15) on Outcomes ResearchChairpersons – Dr D P Pathak, Dr Pramil Tiwari and Dr Bikash Mehdi

4.40–5.40 PM SYMPOSIUM IV Future Of ISPOR, Drug Policy And Costs

Chairpersons – Dr B P Srinivasan and Dr Nirmal Gurbani

International Society for Pharmacoeconomics and Outcomes Research-Vision 2020

J S Bapna, Emeritus Professor, SMS Medical College, Jaipur

Costs & Outcomes of Hospital Acquired Infections in Indian Settings

Pramil Tiwari, Professor & Head, Dept of Pharmacy Practice, NIPER, Mohali, Chandigarh

4.40 PM

5.00 PM

5.20 PM Impact of Policy Changes on Approval of New Drugs in India and its Impact on Access

S C Mandal, Senior Drug Inspector, Kolkata

• Health Economics and Outcomes Research: An Overview

• The What & Why of Systemic Reviews and Meta Analysis

Divya Mishra, Therapy Lead Oncology and Clinical Development, Pfizer Limited, Mumbai.

AIIMS, New Delhi

• Workshop on Systemic review methods including:

a. Devising a Good Search Strategy; b. Assessing Studies and their Quality Mahendra Rai and Javed, Capita India, Mumbai

Basic Concepts, Signal Detection and Signal Management

Rajinder Jalali, Vice-President – Medical Affairs & Clinical Research and Head Global Pharmacovigilance, Ranbaxy Laboratories Ltd, Gurgaon

Causality Assessment of SAEs

Bikash Mehdi, Additional Professor, PGI, Chandigarh

Assuring Quality in Pharmacovigilance System

Moin Don, Executive Director& Founder of PVCON Pharmacovigilance Auditing

Audits and Inspections in Pharmacovigilance

Moin Don, Executive Director& Founder of PVCON Pharmacovigilance Auditing

Post Marketing Surveillance

Manoj Sharma, Asst. Manager, Pharmacovigilance, Panacea Biotech Ltd, Mumbai

Network of PvPI Centres in India

Jai Prakash, Principle Scientific Officer, NCC-PvPI, IPC, Ghaziabad

ADRs – Where to Report, What to Report and How to Report

Kalai Selvan, Senior Scientific Officer, NCC-PvPI, IPC, Ghaziabad

Pharmacovigilance Studies on Various Cosmetics and Neutraceuticals

S S Agrawal, Pro Vice Chancellor, Amity University, NOIDA

Take your discussions further & build new relationships in a relaxed informal setting……….

1.20–2.00 PM Networking Luncheon

2.00 – 5.00 PM SYMPOSIUM CUM WORKSHOP ON Pharmacovigilance & Drug Safety

Chairpersons – Dr Surinder Singh and Dr Rajinder Jalali

on Outcomes ResearchPodium and Poster Presentation (P16-P30)

Chairpersons – Dr Sushma Srivastava and Dr Rajani Mathur

2.00 PM

2.40 PM

3.00 PM

3.20 PM

3.40 PM

4.00 PM

4.20 PM

4.40 PM

4.00-5.00PM

5. 15 PM Closing Ceremony

Consulting Services, Mumbai

Consulting Services, Mumbai

Padma Shri Prof. Ranjit Roy ChaudhuryNational Professor of Pharmacology (NAMS)

Advisor-Department of Health and Family Welfare, Govt. of NCTD

Professor Ranjit Roy Chaudhury is a leading clinical pharmacologist, medical educationist and a researcher of repute in India. After graduating in Medicine in 1954, he proceeded to Oxford on a Rhodes scholarship and completed his D. Phil in Pharmacology. He has been Professor of Pharmacology, Dean and retired as Acting Director of the Postgraduate Institute of Medical Education and Research, Chandigarh in 1980. He has served in various senior positions in the World Health Organization for fourteen years. Since retirement in 1990, Prof. Roy Chaudhury has worked as Emeritus Scientist at the National Institute of Immunology, New Delhi and holds the UNESCO Chair in Rational Use of Medicines at the Chulalongkorn University which conferred on him the honorary degree of Doctor of Science.

Prof. Roy Chaudhury established the first D.M. Course in Clinical Pharmacology at Chandigarh in 1980. He also established, after retirement the Delhi Society for Promotion of Rational Use of Drugs and was the Founder Director of the Delhi Medical Council. He also was Chairman of the Sub-Commission which prepared the Report of the National Commission in Macroeconomics and Health in 2006. He was also a former member of the Board of Governors of the Medical Council of India.

Prof. Roy Chaudhury's major contributions in research are in the field of reproduction pharmacology, clinical trials, rational use of medicines and research on medicinal plants.

He has written twenty books including one on Herbal Medicine in Asia published by the World Health Organization. He has received many honours and distinctions and in 1998 the President of India conferred on him the title of Padma Shri for his contributions to the country in the field of medical research and medical education. He has also been honoured by the Delhi Government by being bestowed upon the Delhi Ki Gaurav award.

He also chaired the Committee for Postgraduate Medical Education in India and since January, 2007 is Chairman of the Task Force for Research of Apollo Hospitals Group in India.

Prof. Roy Chaudhury was a Member of the Committee which drafted the first Ethical Guidelines on Research in Human Subjects of the Indian Council of Medical Research (ICMR) in 1980. He was a member of the Committee which drafted the second ICMR Guidelines in 1994 and chaired the Sub Committee for clinical trials of drugs, vaccines and herbal products. He continues to be a member of the ICMR Ethics Committee and other four Institute Ethics Committees of leading medical centres in Delhi.

He has been nominated as a Member of the Central Council for Health and Family Welfare in 2009. He has been recently appointed as Advisor to the Department of Health and Family Welfare, Govt. of National Capital Territory of Delhi.

International Conference of Pharmacoeconomics and Outcomes Research

rd th23 and 24 November, 2012

8

Dr. Gyanendra Nath Singh Drugs Controller General (India)

Ministry of Health & Family WelfareSecretary-Cum-Scientific Director, IPC, Ghaziabad

Dr. G. N. Singh is the Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission & has been discharging the functions and duties of Chief Scientific and Executive Officer since January, 2009. He holds an additional charge of the Drugs Controller General of India of the Ministry of Health and Family Welfare, Govt. of India from 21st February, 2012.

At his credit, he has a long research and administrative experience of 24 years in the field of drugs and pharmaceuticals. He has authored and published about 110 Research Papers in leading journals and periodicals. He participated/Chaired various national and international seminars/symposia/ conferences. He has been Guide for Master's and Doctorate student's in Pharmaceutical Sciences.

His Scientific achievements are reflected in publishing Addendum 2002 to IP 1996 and Addendum 2005; 5th edition of IP in the form of IP 2007; Addendum 2008 of IP 2007 and 6th edition of IP 2010; Addendum 2012 to IP 2010. The National Formulary of India 2011 is another milestone which promotes rational uses of medicines through generic approach. His team got the Indian Pharmacopoeia Laboratory certified by ISO: 9004 and ISO: 17025. He works for strengthening the Pharmacovigilance Programme of India (PvPI). He is committed to address Regulatory related challenges.



9

Dr. G.J. SamathanamScientist-G & Head (TDT)

Department of Science & TechnologyGovernment of India, New Delhi

Dr. G J Samathanam (b.14.11.1953) did his M.Sc. and Ph.D from Indian Agricultural Research Institute (IARI), New Delhi. He is an elected Fellow of the Indian Association of Biomedical Scientists (FIBMS) and an editorial Board Member of Indian Journal of Nematology.

Since 1988, he has been working on different capacities in the Department of Science & Technology (DST), Government of India. He was associated in the National Science & Technology Management Information System (NSTMIS) and brought out several national reports on Science resources, R&D, Science indicators, manpower, mis-match, brain-drain studies.

Since August, 2009 he is heading the Division of Technology Development & Transfer comprising Drugs & Pharmaceuticals Research Programme (DPRP); State Science & Technology Programme (SSTP); Technology Systems Development Programme (TSDP); Instrumentation Development Programme (IDP); Patent Information Centres (PIC); Liaison activities of Technology Development Board (TDB) and Patent Facilitating Centre (PFC).



10

Dr. Surinder Singh, M.B.B.S, M.D Director, National Institute of Biologicals, Noida

Ministry of Health & Family WelfareGovernment of India

Dr. Surinder Singh is a native of Jammu, J&K State and was born on 02.05.1960. He has done his MBBS from Medical College, Jammu in the year 1985 and M.D. (Microbiology) from Medical College Rohtak, Haryana in the year 1988.He did his senior residency in Microbiology from All India Institute of Medical Sciences, New Delhi (1988 -1991).

He took over the charge of Drugs Controller General of India in February-2008 and continued to work in the same position till 2nd November, 2011. Presently, Dr. Surinder Singh is the Director In-charge of National Institute of Biologicals, Noida which is the National Control Laboratory for testing of all Biologicals including Vaccines and Bio-pharmaceuticals.

Dr. Surinder Singh has 27 Scientific publications to his credit and has inspected 70 Vaccine and Biologicals manufacturing units in the country. Highlights of the career

* Featured in the list of the world's 40 most influential people in the global pharma industry, for third consecutive year i.e. Year 2011, 2010 & 2009 as adjudged by a panel of experts of the UK Pharma magazine "World Pharmaceutical Frontiers"

* Received Pharma-Bio World Awards 2011 - for, "Outstanding Initiatives in Regulatory Environment" given by - CHEMTECH FOUNDATION.

* Member of WHO Global Action Plan for Influenza Vaccines (Year 2010-2012)

* Expert Member in WHO audit team for NRA assessment of Thailand in Year 2007 & 2012

* Co-coordinating the activities of United States Agency for International Development (USAID)-USA, Overseas Economic Cooperation Fund (OECF), JAPAN and Govt. of India in respect of establishment of NIB project (Year 1998- 1999).Further, successfully accomplished the work related to the establishment of Lab & Animal House facility of NIB - designed by National Institute of Health, USA, having an area of 15000 Sq mtr. (approx.) costing Rs.114.11 crores (USD 23 million { Year 2003- 2005})

* Preparation of Proposal for 12th Five Year Plan (2012-2017) for Ministry of Health & Family Welfare , Government of India in respect of strengthening Drugs Regulation in the country at the Centre (CDSCO) and in the States with Financial Outlay of USD 1.39 bn (Rs.6256 Crore.)



11

Abstract

Brief abstract on Overview of Indian Pharmaceutical IndustryDr. Surinder Singh, M.B.B.S, M.D

Director, National Institute of Biologicals, NoidaMinistry of Health & Family Welfare

Government of India

Indian Pharmaceutical Industry is one of the most vibrant sectors of Indian Industry and has beengrowing at the rate of 14% per annum. It is the 3rd largest in the world by volume and 13th in value. The totalsize of the Indian Pharmaceutical Industry is about Rs 1,26, 000 crore out of which exports account forRs 63,000 Crore and the rest is the size of the domestic market. It is 8% of global production and 2%of world pharma market.Drugs fall under the concurrent list of the Constitutionand are regulated under the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945.The Act is a Central Act, enforced by both Central and State Govt. A series of measures have been taken by Ministry of Health and Family recently to strengthen the regulations in area of Clinical Trials, Post marketing Surveillance/PSUR , Medical Devices, Pharmacovigilance & initiation of overseas inspections.

A budgetary provision of Rs. 6256 Crores has been projected by the Ministry in 12th Five Year plan for strengthening of the Central & State Drug regulatory system in the country.



12

Professor (Dr) S. K. GuptaEmeritus Professor

Delhi Institute of Pharmaceutical Sciences & Research Advisor/Consultant

Pharmacovigilance Program of India (PvPI)Ministry of Health & Family Welfare

Dr S K Gupta was formerly Head, Department of Pharmacology at All India Institute of Medical Sciences, New Delhi and has been Dean & Director General Institute of Clinical Research (India), which is one of the premier and pioneering Institute in the country.

He is the founder of National Pharmacovigilance Center at AIIMS. In recognition of his outstanding contributions in the field, Dr. Gupta has been nominated as expert-member of a number of committees of DST, DBT, CSIR and Ministry of Health and Family Welfare; Govt. of India, and was member of governing body of the Central Council of Research in Ayurveda.

He has been conferred with prestigious Fellowships of International Society of Eye Research USA and International Academy of Cardiovascular Sciences, Canada. He has been visiting Professor to several prestigious universities in UK, USA, Germany etc. Dr. Gupta has been recipient of prestigious awards and was recently conferred the ‘Distinguished Services Award in Cardiovascular Science, Medicine and Surgery’ by International Academy of Cardiovascular Sciences, Canada. and Dr. Gupta has several patents to his credit and one of his ophthalmic formulations is being commercialized.

At present, Dr. Gupta is President of the International Academy of Cardiovascular Sciences and Member, Executive Committee of the International Society of Heart Research (India Section). Dr. Gupta has published more than 250 research papers and edited seven books and has guided more than 150 postgraduate students.

He is elected fellow of IPS (India), ISER (USA), IACS (Canada) and FRSC (Romania). Recently, he has been nominated as Advisor, Pharmacovigilance Program of India (Min. of Health and Family Welfare).



13

Petr Hajek, BSc & MSc (Natural Sciences)

Petr holds a BSc and MSc in the natural sciences and has more than 13 years of experience in health outcomes and clinical research.

Petr began his pharmaceutical career at Sanofi, then moved to Pharmacia and then Pfizer were he has held positions in both medical affairs and outcomes research. Since 2005, Petr has been responsible for Outcomes Research in Pfizer Czech Republic country office. Petr was a Team Leader Medical Affairs/Outcomes Research in 2007 - 2009 and has also experience market access area as a Senior Access Manager. Petr is the HEOR Director for Emerging markets Europe including Russia, India and Turkey.

Petr is a member of board of the Czech ISPOR Chapter since 2009. He is also the founding member of the Association of Innovative Industry Health Economy Task Force. Petr has several publications and presentation experience of outcomes research studies both at international and local level. He participated at Health Economics Summer School, Heidelberg 2007, 2008 and other OR trainings.

AbstractValue Based Pricing - New Trend in Health Technology Assessments

HTA agencies can be divided in to two groups. First group focuses mostly on clinical effectiveness. Clinical evaluation of added value vs. comparator is the main driver for reimbursement setting. This HTA approach is represented by countries like France or Germany. Second group focuses on cost-effectiveness. Cost per additional Quality adjusted Life Year (QALY gained) or cost per Life year gained (LYG) are major variables of such appraisals. Typical representative of this group is UK (NICE), Netherlands, Sweden or Australia (PBAC).

UK Government recognizes that there are significant failings within the current cost per QALY approach and government proposed reform of NICE. Value Based Pricing reform in the UK will be discussed. This reform is encompassed by Value Based Pricing principles which should reflect not only cost-effectiveness evaluation (cost per QALY) but also other variables: Burden of illness and assessment of innovation.

Dr. Simu K Thomas MS M. Pharm Ph.D

Dr. Simu K. Thomas is the Global Head and Executive Director of Health Economics Modelling at Novartis. With more than 15 years of experience as a Health Economist, he leads a multidisciplinary team and affiliated experts to lead the development and execution of health economics strategies for Novartis. Prior to this, he was the Global Head for health economics/outcomes research for Neuroscience and Ophthalmics franchises of Novartis. He has worked throughout North America, Europe and Asia and has considerable experience and knowledge of the health care systems in those regions.

Dr. Simu has authored more than 30 peer reviewed manuscripts and 60 congress presentations and co-authored book chapters in the field of Pharmacoeconomics. He is an invited lecturer in several leading universities. He maintains a strong interest in drug use economics, decision analysis, outcomes research, health technology assessments and market access. He is also a member delegate to the ISPOR Institutional Council. He has a PhD in Pharmaceutical Economics from the University of Maryland, MS in Pharmacy Administration from the University of Toledo and Pharmacy degrees from Birla Institute of Technology & Science, Pilani, India. Dr. Simu also serves as Adjunct Assistant Professor at University of Maryland, USA.



14

Abstract Health Technology Assessments - International Perspectives

Simu Thomas, Executive Director, Global Head, Health Economics Modeling,Novartis Pharmaceuticals Corporation, USA

This introductory discussion is designed to provide an overview to academic researchers, health policy decision makers, manufacturers and clinicians about the key elements, methods and language of health technology assessment (HTA). European health care systems are primarily government payer models; therefore, based on each country's set of laws and values, wide variations exist in health technologies. The discussion topics would focus on the commonly used methodologies and the perspectives of different stakeholders in the implementation of HTA in decision making. Demand for real world evidence is central to drive HTA decisions; implications on market access strategies will also be discussed.

Dr. Shanlian Hu, PhD

Director of Health Management Training Center Director of Pharmacoeconomic Evaluation and Research Center

Dr. Shanlian Hu is a Professor of Health Economics and Ph.D Mentor in the School of Public Health, Fudan University, The Director of Health Management Training Center, and the Director of Pharmacoeconomic Evaluation and Research Center. At present, he is the Director of Shanghai Health Development and Research Center. He also has other social responsibilities, such as the member of State Council Deepening Health Care System Reform Advisory Committee, member of MOH Deepening Health Care System Reform Advisory Committee, member of Health Policy and Health Management Advisory Committee, member of community health advisory committee of MOH, member of Shanghai Health Reform and Development

Advisory Committee. Member of Steering Committee of MoHRSS, and Steering Committee member of China Medical Insurance Association. He was invited as Visiting Professors in Shanghai Second Military Medical University, Xi'an Medical University, Dalian Medical College, Zhejiang University and South-East University in Nanjing.

He was also a member of Health System Research Committee in WHO/WPRO, member of Alliance of Health Policy and Systems Research in WHO. A temporary consultant in Essential Medicines in WHO/Geneva, and the Past Board Member and the Past Chair of Asia Consortium in International Society of Pharmacoeconomics and Outcomes Research (ISPOR) in 2008-2010.

In the recent years, he has involved in many research projects supported by MOH, NDRC, Shanghai Bureau of Health, Shanghai SFDA, UNICEF, World Bank, WHO, Merck Foundation, and many international pharmaceutical companies. His main interests are health financing, healthcare system reform, new rural cooperative medical system, urban community health, equality of public health services, payment system reform, drug pricing, essential medicine policy and pharmacoeconomic evaluation, etc.

He graduated from Shanghai First Medical College in 1957, and pursued MPH in Epidemiology. He received MSc. degree in London School of Hygiene and Tropical Medicine, London University in 1982. And followed by WHO fellowship training in UCLA, UC Berkely, and Harvard School of Public Health in 1986-1987.

AbstractThe Recent Status of HTA Development in Asia

Dr. Shanlian Hu

Health technology assessment (HTA) is being fast grown in Asia. South Korea, Thailand and Taiwan are more advanced in establishing assessment agency and appraisal committee, which



15

can be research-based or reimbursement- based to do the drug, medical devices and diagnostics appraisals. But in some Asia countries, the HTA environment is still very much in its infancy time. The presentation will start to introduce the concept of HTA and the factors influencing on the value-based pricing and key criteria for drug listing and reimbursement. Some results of drug coverage assessment will be provided in different Asian countries. HTA in China mainland is currently very scattered and decentralized, there still lacks a centralized framework for HTA.

Political support, legal framework, capacity building and evaluation skills are essential conditions to develop HTA in local setting. In the future, countries in Asia should consider building up their pharmacoeconomic guidelines, requirements for submission document and price negotiation criteria. HTAnetAsia will be a platform for information sharing and to exploit the possibility of close collaboration on further HTA initiatives in the region.

Dr. Vladmir Zah, Ph.D

ZRx Outcomes Research Inc., Canada

Vlad brings over 15 years of technology and business experience to his position at ZRx Outcomes Research Inc. Since 2000, Vlad has implemented over 150 health economic models and assessments across various disease areas, whilst working as a consultant with top 20 global pharmaceutical companies in both phase II and phase IV, in a role of a project manager, health economist or chief investigator. Since 2004, Vlad resides as an active member on various ISPOR (International Society for Pharmacoeconomics and Outcomes Research) Special Interest Groups, judge at the congresses and reviewer.

Vlad is a co-author of best outcomes research internal project at Pfizer for year 2005 (early valuation modeling). Since 2007, he is one of the founders and was

acting President of ISPOR Serbia Chapter 2007-2012. Vlad was also a co-chair @ ISPOR Prague 2010 meeting.

He is very active as lecturer. Vlad is also utilized as KOL for HIV, Diabetes and other disease areas.

His PhD work on Early vs. Late HIV detection in UK has helped reformulate policy towards early detection in UK in 2011.

Abstract HTA importance in the EU member states and countries on the list to join

Vladmir Zah

As the global economic crisis deepens, aging population, rising healthcare costs and reforms are underway. Over the last couple of years, healthcare reforms have come into the spotlight of the parliamentary and presidential elections. As such, focus on health technology assessment legislations has gained ground around the world.

According to the OECD (Organisation for Economic Co-operation and Development), to be useful to decision makers, HTA must be tailored to the decision nodes of the health-care system and the needs and interests of decision makers at each of these nodes. It also needs to be deployed in an efficient and timely manner. This has not been the case in many countries. In EU (European Union), revised Transparency Directive 89/105/EEC now requires HTA process to be conducted within 120 days.



16

Dr. J S Bapna, Ph.D

Emeritus ProfessorSMS Medical College, Jaipur

Jawahar S. Bapna PhD, is Emeritus Professor SMS and Director, Jaipur College of Pharmacy, Jaipur. He has held very senior positions of Government of India such as Director of Institute of Human Behaviour & Allied Sciences, Additioal DG of Ministry of Heath and Director Professor at JIPER, Pondicherry and Maulana Azad Medical College, New Delhi. He is recipient of prestigious United States Public Health International Fellowship. He has an extensive experience of research with international agencies such as WHO, World Bank, EU, Euro Health Group, MSH, The Futures Group International, Danida etc. Recently he conducted at RUD training of prescribers at Afghanistan, supported

by Danida.

He has been member of various high power committees of Govt. Of India such as Pharmacopoeia Committee, Essential Drugs Advisory Committee, Pharmaco-vigilance Committee etc. He has several years of experience of working with WHO on Essential Drugs Programme. He developed "Guide to Good Prescribing" of WHO which is their best selling book. He has assisted the Delhi, Madhya Pradesh and Rajasthan Governments in developing Drug Policy including Essential Drugs List, procurement, quality assurance and the Standard Treatment Guidelines

AbstractInternational Society for Pharmacoeconomics and Outcomes Research-Vision 2020

J S Bapna, Emeritus Professor, SMS Medical College, Jaipur

ISPOR is a non-profit, international, educational and scientific organization that fosters excellence in pharmacoeconomics and health outcomes research and the appropriate use of resulting information in health care decisions at all levels to promote the public health and well-being. ISPOR has over 5500 active members from 90 countries and an additional 3300 members from its 43 Regional Chapters. The goal of the Regional Chapters is to disseminate knowledge and bring the research tools of ISPOR to all localities worldwide.

ISPOR provides and promotes quality education on Pharmacoeconomics and outcomes research principles through its short courses and distance learning programs.

Through annual international meetings, Value in Health (ISPOR's peer-reviewed journal), and scientific working groups, ISPOR facilitates and encourages the interchange of expert knowledge and communications among the research community, health care professionals, practitioners, decision-makers, manufacturers, payers, policy makers and educators around the globe. ISPOR provides tools for health care researchers as well as health care decision makers such as the ISPOR Good Research Practice reports which are consensus documents on key outcomes research methods.

Specialties

Pharmacoeconomics, health economics, health technology assessment, real world data in outcomes research, modeling, patient-reported outcomes (quality of life), clinical observational or retrospective study research methods, outcomes research.



17

Robert Plisko

CEO, HTA Consulting ul. Starowislna, Poland

Robert Plisko. Health economist with 12 years in Health Technology Assessment. CEO of HTA Consulting - leader of the Polish market of HTA analyses. Robert Plisko is developing and creating leading services related to health technology assessment and consulting concerning systemic solutions in health care. So far, HTA Consulting has developed more than 300 complete HTA reports. Currently Robert Plisko is involved in running several projects in Asia Pacific countries.

Health care systems become more and more "evidence based". Supply of high quality evidence grows instantly. Assessment of efficacy, effectiveness, safety profile as well as cost-effectiveness and cost-utility of health technologies has been endorsed by law in many developed countries for years. This is to avoid wasting public money on technologies of unproven efficacy, these efficacious but with high risk of side effects, efficacious but relatively very expensive and therefore not worth paying for in respect to benefits offered. Necessity to limit arbitrary decisions implicates development of detailed criteria, ensuring reproducibility of official decisions based on a defined amount of objective information. Reproducibility of decisions related to availability of objective information requires use of the results of credible, methodologically correct analyses and studies in the decision process.

Health Technology Assessment (HTA) has been developed to answer the needs of health policy makers and to address questions on efficacy, safety, and cost-effectiveness of health technologies. Collected and analyzed evidence is then referred to possibly transparent and rational criteria of coverage and pricing. Therefore HTA has become one of the most important tools in development of benefit packages around the world.

Dr. Chandrashekhar Potkar, M.D., M.B.A., M.S.H.S

Director, Medical and Regulatory AffairsPfizer Limited - India

Dr. Potkar has medical, management and clinical research background with MD in Pharmacology from University of Mumbai, MBA from Deakin University, Australia and thereafter his MS, Clinical Research Administration from the George Washington University, USA. At the beginning of his career, he was in academia as a Lecturer in Pharmacology at KEM Hospital for 3 years. In the industry, his first job was at Searle Pharmaceuticals. He joined Pfizer clinical research as Medical Advisor in 1995. He assumed the responsibility of Director, Clinical research in June 2000. In Jan 2006, he added regulatory affairs portfolio to his responsibilities

and was appointed Director Clinical Research & Regulatory Affairs.

Dr Potkar did a four month secondment in Medical division of Pfizer Korea as Director Clinical Research. He was responsible for conceptualizing Pfizer R & D University initiative for capacity building that was rolled out at 3 universities during his stay. He also contributed to streamlining of HR and financial processes for Pfizer Korea Medical division.

He was appointed as Director Medical & Regulatory Affairs in April 2007.

He is one of the founder governing council members and faculty at Academy for clinical Excellence, the training center for clinical research at Mumbai in collaboration with Bombay College of Pharmacy and Suven. Dr. Potkar is also the founder member of Indian society for clinical research, the professional society for clinical research professionals in India. He is a life member of Indian Psychiatry Society and Indian Pharmacology Society.



18

Dr. Arun D Bhatt, MD (Med), FICA (India), FICR (UK)

President, Clinivent Research Private Limited

Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry. He has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited.

Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research - the journal of ISCR.

In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research.

Dr Bhatt is recipient of DIA outstanding Service award 2012 for his immense contributions in his field of specialization.

Dr Bhatt has more than 100 publications in national and international journals. He runs a regular monthly column on "Good Clinical Practice - Question Answers" and has published a book "Clinical Trials and Good Clinical Practice in India - Your Questions Answered".

Abstract

Clinical Trials in India: Moving to Qual-economics?Dr Arun Bhatt

President Clininvent Research Pvt [email protected]

Indian clinical research has been attractive due to potential advantages of speed recruitment of clinical trial subjects and cost. In order to meet these expectations, the conventional model is to use a small number of clinical trials, which can recruit a large number of subjects in a short time period. The quality of clinical trial conduct at the site depends on good documentation. This focus on speed puts pressure on the site time available for trial conduct, documentation and GCP compliance. Quality suffers from the focus on speed. There is a need to develop an alternate model which makes it easy for sites and sponsors to maintain quality. One alternative is to use increase the number of sites and reduce the number of subjects recruited per site. However, it would be essential compare the cost of the 2 models and potential benefits of alternate model over conventional model. The presentation will cover cost comparison of the 2 models considering diverse costs - site, monitoring, project management etc - and pros and cons of 2 models vis-à-vis quality and speed.

Dr. Sinem Ezgi Gülmez, MD, PhD

Associate Professor of Pharmacology email address: [email protected]

Dr. Gulmez is a medical doctor and a pharmacologist, graduated Ankara University Faculty of Medicine, Ankara, Turkey. In 2010, she became university associate professor of pharmacology.

Her research area is pharmacoepidemiology and clinical pharmacology. She is a peer reviewer of JAMA, Archives of Internal Medicine, Epidemiology, PDS, and BCPT. She was the Editor of the E-bulletin of Working Group of Clinical Pharmacology of the Turkish Society of Pharmacology.

She sat in the European Association for Clinical Pharmacology and Therapeutics (EACPT) Council from 2003-2011 as Representative Delegate of Turkey. She was the member of the Executive Committee of Turkish SCP



19

Chapter of International Society for Pharmacoeconomics and Outcomes Research (ISPOR) from 2007-2010.

She is currently working at the Department of Pharmacology of the University of Bordeaux, leading European projects on hepatotoxicity of NSAIDs. Prior to this, she worked at University of Southern Denmark from 2005-2007 and conducted research projects in pharmacoepidemiology.

AbstractThe Importance of Pharmacoepidemiology in Pharmacoeconomical Studies

Sinem Ezgi Gülmez, Associate Professor of Pharmacology, MD, PhD

Pharmacoepidemiology is the study of the use and effects/side effects of drugs in populations to support rational and cost-effective use of drugs in the defined populations, so improving health outcomes (rational use, efficacy, tolerability, effects on the population). It applies epidemiological methods and knowledge in order to determine drug utilisation patterns, improve rational use of drugs, and estimate the frequency and severity of side effects. It is the scientific backbone of therapeutic risk management. Pharmacoeconomics is the branch of economics, uses various methods to compare medicinal products and treatment strategies. It can help to determine whether a new costlier product offers sufficient clinical advantage over its predecessors to justify the increased cost. Pharmacoeconomics could benefit from the strong pharmacoepidemiological methodology for estimating parameters that are essential to any health economic evaluation.

Munish Duvedi, M. Pharm

Clinical Research Associate II, Pharmanet - i3, Gurgaon

AbstractRole of Pharmacoeconomics in Health Policy

Need for an informed health policymaking in low and middle-income countries

Munish Duvedi, Clinical Research Associate II, Pharmanet - i3, Gurgaon

Low and Middle income countries (LMC's) across globe, are today grappling with ever increasing fiscal deficits in their annual national budgets to meet objectives and needs of human development and welfare programmes. As this deficit grows, ironically health

care spending is affected most. India being a vast country has several polices, schemes and programs governing its health care systems e.g. National Health Policy of India 2002, National Health Research Policy- 2011,National Rural Health Mission and proposed National Urban Health Mission (NUHM) etc. Several other policies enunciated by the Government of India (Population Policy 2000, Health Policy 2002, Science & Technology Policy, 2003) have equivocally stressed the importance of health research to improve health of the nation but clearly missed to underline the importance of the economics of health care delivery to ensure cost effectiveness of programmes. In comparison almost all the developed countries and countries in South East Asian Regions have a pharmacoeconomics policy or related mechanisms and increasing relying on them to make informed decision at policy levels. India still lacks one such organization, however newly created Department of Health Research in MoHFW can play such role , but elements of PharmacoEconomics, Health Technology assessment and Outcome Research are lacking from the vision statements and it mandate. It is widely accepted that health care is limited resource and economics plays an important role in making decisions.



20

Dr. Mrs. Nilima Arun Kshirsagar,

National Chair in Clinical Pharmacology, Indian Council of Medical Research, Govt. of India,Dean, ESI-PGIMSR, MGM Hospital, Dr. S. S. Rao RoadParel, Mumbai 400 012

Dr. Kshirsagar is National Chair Clinical Pharmacology, Indian Council of Medical Research, Govt of India New Delhi and Dean ESI PGIMSR Govt of India MGM Hospital Parel Mumbai, and former Dean Director GS Medical KEM Hospital, Mumbai, Acting Vice Chancellor, State Health Sciences University, Hon.Director Professor, Department of Infectious Diseases and Interdisciplinary Research, Maharashtra University of Health Sciences, Emeritus Professor, Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel Mumbai, 400012. She has over 30 years of experience in clinical pharmacology

She received her training in Mumbai, India and at St. Bartholomew's Hospital UK and is MD, PhD. DNB, FNASc, FNAMS, Fellow of Royal

College of Physicians, Faculty of Pharmaceutical Medicine UK and Fellow of American College of Clinical Pharmacology. She has been Member of WHO committees on Medicines Safety, and Drug Product development, Drug Statistics Methodology, Chairman Academic Committee of AIIMS, President of Indian pharmacological society & Infectious Diseases Society of India.

A University topper with several awards and gold medals including Dr B. C. Roy National Award, Vasvik Award for industrial Research, Lifetime Achievement Award of ICRI, and Mayor's Award. She has developed, patented and carried out clinical trials on liposomal amphotericin B for systemic fungal infections. The drug is marketed. She has delivered several prestigious orations and received NIH and WHO research grants.

She spearheaded the development of National Pharmacovigilance program and she has over 200 publications in National and International Journals including Lancet, British Journal of Clinical Pharmacology, American Journal of Tropical Medicine, Journal of Antimicrobial chemotherapy, etc.

Abstract

ICMR Program on outcomes research and antibiotic stewardship capacity buildingDr. N A Kshirsagar*, Dr. Lalita Savardekar, Dr. Sujit Chandy, Dr. Rajni Kaul

Drugs approved for marketing in India have increased dramatically in past few years however the lag time for withdrawal of drug from market has not changed that much, indicating need for post marketing studies. Antibiotics resistance and stewardship for rational use is also essential to enhance its utilizable life span. Indian Council of Medical Research (ICMR) recognizing this need conducted under development of clinical pharmacology program hands on workshop on outcomes research and antibiotic stewardship at Mumbai & Vellore respectively. Participants were selected from all over India. As part of the workshop they submitted multicentre research proposals. These projects will train them in various aspects and will also provide much needed data on current practices, outcomes, interventions required, effect of interventions and way forward for further capacity building as well as implementation policies.

MD, PhD. DNB, FNASc, FNAMS



21

Prof. Dr. SS Agrawal, Ph.D

Pro Vice-Chancellor, Amity University, Noida, Uttar PradeshFormer, Founder Director of Delhi Institute of Pharmaceutical Science and Research (DIPSAR)

Prof. S.S. Agrawal's spectrum of research include studies of drugs on Antifertility, infertility, standardization of herbal drugs and their screening for hepatoprotective, anticancer, analgesic and anti-inflammatory effects, Development of TDDSystem for cardioactive agents and Phosphodiestrase-V inhibitors, , Studies on adulteration in herbal aphrodisiacs, Dentrifices as well as cosmoceuticals, BA/BE studies and Clinical trials( Phase -I) .

Professor S.S. Agrawal is presently serving as Pro-Vice Chancellor & Director General (Amity Institute of Pharmacy, Amity Institute of Physiotherapy, Amity Institute of Hospital Administration & Public Health and Amity Institute of Physiology and Allied Sciences), Amity University, Noida, Uttar Pradesh.

He has been conferred with "Honorary Foreign Fellow" by Romanian Academy of Medical Sciences- Romania in 2010, "Distinguished Service Award" by - International Academy of Cardiovascular Sciences, Canada in 2010, Principal of the Year Award 2007- conferred by Association of Pharmaceutical Teachers (APTI), "Honorary D.Sc. Degree" from Rajiv Gandhi Technical University, Bhopal in 2007, "Lifetime Achievement award" by Indian Pharmacological Society (IPS) in 2006, "Fellow of International Society of Heart Research (ISHR)" in 2003 besides many other prestigious awards.

He has guided 24 Ph.D. (05 more Ph.D. under guidance), more than 200 M.Pharm and he has 6 Books to his credit. He has filed 25 patents out of which 3 have been granted.

Abstract

Outcome of research done of Pharmacovigilance – Adulteration of Tobacco in non tobacco products, Adulteration PDE-5 inhibitors in Ayurvedic & Unani drugs,

Adulteration of Heavy Metals in Cosmetics & excessive addition of fluoride in denitrifiesProf. S. S. Agrawal

Amity University, Noida, Uttar Pradesh

We have been estimating tobacco in non tobacco products like Toothpaste and Dantmanjan since 5 years, we have also been estimating the lead, arsenic, cobalt, nickel & cadmium contents in various cosmetics, PDE-5 inhibitors in Ayurvedic & Unani aphrodisiac formulation and fluoride contents in dentifrices since about 5 years

The lead contents results in cosmetics were alarming; however there has been a constant reduction in arsenic, lead etc concentrations in cosmetics, over the years.

Similarly, the large amounts of tobacco were found in large number of toothpastes initially, but in this year majority of brand did not contain tobacco.

The PDE 5 inhibitors however were adulterated in Ayurvedic aphrodisiac and were alarming and we have not found any reduction of PDE 5 inhibitors adulteration in Ayurvedic drugs rather we have found more brands adulterated with of PDE 5 inhibitors.

The fluoride contents have been found in much higher concentration in Toothpastes and Dantmanjans.

The detailed result obtained during the past about 5 years in all the four studies will be presented.



22

Dr. Sakthivel Selvaraj, Ph.D

Health EconomistPublic Health Foundation of India.Email: [email protected]

Dr. Sakthivel Selvaraj is a Health Economist who is currently engaged in teaching and research in the area of health care financing, pharmaceutical economics and equity in health care financing and delivery in India. He was a Takemi Fellow (Post-Doctoral Fellow at Harvard School of Public Health, Boston, US) and a Fulbright Scholar during 2006-07. He has a Ph.D. in Health Economics (1996-2001) from Jawaharlal Nehru University, New Delhi. Earlier, he was engaged as a Health Economist in the National Commission on Macroeconomics and Health (NCMH), Ministry of Health and Family Welfare, New Delhi during 2004-05. S. Sakthivel also served as Consultant in National Commission on Enterprises in Unorganised Sector in India and as a Fellow at Institute for Human Development (2005-06). Before joining NCMH, he was

engaged as Research Associate in the Institute of Economic Growth (2002-04).

His areas of interest include Health Economics, Macroeconomics and Labour Economics. In particular, he specializes in health financing, issues on access to drugs and pharmaceuticals, economics of tobacco, etc. He is also involved in developing curriculum/course materials and teaches in the area of Health Economics for short and long term training/diploma programs. He has published articles in reputed national and international refereed journals.

Abstract

The Role of Access to Medicines in Universalising Health Coverage in IndiaSakthivel Selvaraj, Health Economist, Public Health Foundation of India.

Rationale: India's drug policies over the years have created an environment of duality, wherein the country not only boasts of producing adequately to the domestic consumption but has propelled into being called the 'global pharmacy of the south', exporting life-saving drugs to developing countries. Despite this seemingly commendable performance, millions of Indian households do not have access to drugs (Chaudhury, S. 2007; Selvaraj, S. And Veena Nabar, 2010), as a result of financial (lack of the necessary purchasing power) or physical barriers (lack of public health facilities) (WHO 2004; 2010).

Objective: The critical objective of this paper is to examine - the current impediments to access to medicines in India; articulate the need for upscaling access to medicines so as to achieve universal access to medicine in the next 5-10 years; explore the potential challenges and opportunities in achieving this objective; provide a broad set of eventual expected outcomes from scaling up with financial implications.

Data and Methods: The evidence base of situational analysis that brings out the current obstacles to access to medicines are essentially obtained from few data sources, such as, the large National Sample Survey (1999-00 and 2004-05), budget documents of the government (both central and state governments) and IMS (2007-2011). The large national sample survey of households on consumer expenditure is utilised to provide evidence on the emerging lack of financial risk protection due to large OOP spending by households. The budget documents of the government helps us to understand the current spending pattern and the need to reallocate and upscale public spending on drugs. The IMS data is used to look at the present irrational prescription and dispensing pattern of drugs in India. However, the IMS data and the procurement data from few Indian states are also used to basically provide a roadmap of how irrational drugs could be weeded out and how economies of scale with monopsony power could be a major tool to efficiently utilise resources to achieve the objective of universal health coverage.

Expected Outcomes: Scaling up public spending and allocating atleast 15% for drugs is expected



23

to dramatically reduce out-of-pocket spending for households. i) The current adverse ratio of Govt : Households on drug spending would likely to be reversed or atleast substantially reduced from 1:10 to 1:1 to 2:1 ratio; ii) The potential for significant reduction in impoverishment and catastrophic spending due to OOP expenditure on drugs is enormous; iii) A centralized drug procurement and decentralised distribution mechanism would bring in the much needed economies of scale leading to value for money due to monopsony purchase. This is further strengthened by allowing for purchase of drugs only from essential drug list and therefore generic drugs; iv) Bringing in all essential medicines into price control would put salutary effect on open market drug prices, resulting in large savings to households; v) Strengthening drug control institutions and manning the drug control authorities with adequate skilled workforce is expected to reduce production and sales of spurious and sub-standard drugs in the market and thus gain confidence of the public in respect to drug quality.

Conclusions: While recognising major challenges in implementing these recommendations are multifold - financial, technical and political - but the opportunities that is expected from achieving universal access to medicine is enormous. It is important to recognise the need to strike balance and ensure consensus & convergence of various objectives so as to involve all key stakeholders in discussion and dialogue.

Dr. Madhur Gupta, MD (Pharmacology) DM (Clinical Pharmacology), AIIMS

Technical Officer (Pharmaceuticals)WHO Country Office for India

KEY AREAS OF THE WORK IN WHO COUNTRY OFFICE FOR INDIADevelopment & implementation of National Drug and Vaccine Policy & related areas, including development of National Standards and Guidelines for medical products and technologies, and providing technical and operational support for capacity building of the . This includes strengthening of technical assistance for preparation of guidelines, manuals and reference documents related to drug policy implementation, including vaccines and biologicals' regulation and safety issues, support for updating of Essential Medicines List, capacity building of Drug Regulatory Authorities to improve access to Essential Medicines, support for strengthening of Pharmacovigilance Programme of India (PVPI), strengthening quality assurance mechanisms and standard reference materials and support initiatives for strengthening of GLP,

GCP,GMP and GPP at national and sub-national level.

RESEARCH EXPERIENCE & ACHIEVEMENTS

* Served as an Editor of the book 'Contemporary Perspectives in Clinical Pharmacotherapeutics' published under the imprint of Elsevier Publishing Co. worldwide in January 2006. The book serves to be a unique blend of clinical pharmacology and applied therapeutics in medical practice.

* Awarded the "Shakuntala Amir Chand Prize" by Indian Council of Medical Research which is presented for significant research contributions by young scientists in biomedical sciences. The award was presented for the year 2005 for research work on "Pharmacotherapy of Epilepsy in children".

* Invited Reviewer for various international indexed medical journals like 'Atherosclerosis', 'Acta Neurologica Scandinavica' 'Postgraduate Medical Journal' by the BMJ Group. Former Associate Editor of Indian Journal of Physiology & Pharmacology (Pharmacology Section), an indexed medical journal of repute.

* Published research work in international and national peer reviewed journals of repute and has 52 research publications to her credit.



24

AbstractUniversal Access of Generic Quality Medicines: WHO Perspective

Dr Madhur Gupta, Technical Officer (Pharmaceuticals),WHO Country Office for India, New Delhi

WHO recognizes that expanding access to essential medicines and other critical public health commodities is a global priority and must be viewed within the context and recognition of the importance of the right to health for all. To achieve the goal of Universal Access requires the organization of the health system that ensures equitable access to services, including medicines and other health technologies: the lack of access is on of the most tangible indicators of disparities and inequities that exist between countries and within population groups, specifically vulnerable populations.

Improving the stewardship role of health authorities is an important part of health system strengthening. The World Health Assembly, and the Executive Board of the World Health Organization (WHO) have adopted a number of resolutions to ensure access to quality-assured medicines, vaccines, and medical products as well as other medical processes and interventions required to ensure universal access.

WHO remains committed to supporting countries in:

* Promoting universal access and strengthening health systems, including through support for the development and implementation of national pharmaceutical policies

* Strengthening regulatory capacity in activities involving research and development, production, and rational use of health technologies that will ensure their quality, safety and efficacy and in a manner that ensures efficiency, accountability, and transparency of regulatory processes.

* Strengthening the steering role and regulatory capacity of the National Regulatory Authorities as part of its strategic and programmatic orientations to strengthen health systems based on primary health care. Providing guidance to National Regulatory Authorities in norms and standards for medicines, vaccines and other medical products and; providing information on systems and procedures for the initial approval of pharmaceutical products and vaccines (prequalification) to safeguard the quality of products procured through United Nations agencies.

* Proposing and accompanying initiatives, including universal coverage schemes, aimed to rapidly scaling up access to medicines within health systems, especially for essential medicines in NCDs, NTDs and diseases related to MDG 4, 5 and 6.

* Facilitating exchange between national regulatory authorities in key regulatory issues and developing collaborative platforms and networks that promote horizontal cooperation between Member States.

Dr. Nirmal Gurbani, Ph.D, LLB

Professor and Associate Dean (Pharmaceutical Management) Indian Institute of Health Management Research (IIHMR), Jaipur

Holds PhD, LLB and PGDHRM and is a Fellow of IPA. He has been associated with teaching and managing a Government pharmaceutical institution for over 33 years and is currently the Professor and Associate Dean (Pharmaceutical Management) at Indian Institute of Health Management Research (IIHMR), Jaipur - a WHO Collaborating Centre. He is also the Honorary Adviser to Rajasthan Medical Services Corporation (RMSC), a Government of Rajasthan, initiative for free essential medicines to all. On WHO fellowship, he has undergone a specialized training at Management Sciences for Health (MSH), Washington DC, on Rational Pharmaceutical Management. He is a resource person with various international and national courses on rational



25

use of medicines including prudent use of antimicrobials, infection control programs for doctors, nurses & pharmacists, Phamaco-economics, Promoting RUM in Communities, ARV & Related Supply, DTCs and Monitoring Medicines Prices in various states of India under WHO, WB, EC, SEARPharm Forum, Danida, Cordaid, IPA, NACO and DPT supported programmes. He has expertise in initiating Advocacy at Policy level, Pharmaceutical Situational Analysis, Consulting in Studies. On WHO support, he has attended International Course in Pharmacoeconomics (Money, Evidence and Drug Selection) at Budapest in 2001 with immediate replication of this course in India (New Delhi & Jaipur) in 2002 as one of the Organizing Secretary under the umbrella of the DSPRUD. He has also worked as Technical Coordinator WHO India Essential Drug Programme (2004-05). He has been the Member Secretary of Rajasthan State EML Committee (12 years) and Rajasthan State STGs Committee (5 years). He has co-authored ten books with distinguished professionals, contributed specific chapters in professional books of other authors and important government/ professional documents/manuals.

AbstractAccess to Medicines - Rajasthan Model

Nirmal Gurbani, Professor & Associate Dean (Pharmaceutical Management)Indian Institute of Health Management Research (IIHMR), Jaipur.

Access to quality medicines is one of the critical issues in global efforts toward Universal Health Care. As per WHO only one-third population has access to medicines in developing countries. Public expenditure on health in India is around 1% of GDP and 79 % expenditure in health of people is through out-of-pocket. There is evidence that almost 30 % of the households slide into poverty due to high treatment costs and medicines. Although, India is globally regarded as "Poor man's Pharmacy", yet, two-thirds of the population do not have regular access to essential drugs. The Government of Rajasthan with population around 68 million, has launched a scheme called Chief Minister's Free Drug Distribution Scheme (CMFDDS) on 2nd October 2011 for providing free quality generic essential medicines to all people at the government health facilities irrespective of their BPL or APL status through establishing 13,874 drug distribution centres. An autonomous "Rajasthan Medical Services Corporation" (RMSC) has been set up to execute the scheme encompassing four basic ingredients for access to medicines, viz. rational selection & use, affordable prices, sustainable financing and reliable health system. Around 350 essential generic drugs with other essential health products are now being distributed free of cost. As a result, outpatient visits have jumped 60 percent and inpatient admissions are up 30 percent Details of procurement, distribution and dispensing of medicines to public will be shared during the presentation.

Dr. Anita Kotwani, Ph.D

Associate Professor, Department of PharmacologyV. P. Chest Institute, University of Delhi, Delhi 110007, Email: [email protected]

Anita Kotwani is an Associate Professor in the Department of Pharmacology, V. P. Chest Institute, University of Delhi, India. Her research interests comprise access to medicines; rational use of medicines; surveillance of antimicrobial drug use and containment of resistance; population medicine and; quality of health care focusing on bronchial asthma.

Dr. Kotwani has expertise in measuring medicine prices, availability, affordability and price components in public and private sector. She has served as a technical advisor (India) and country coordinator on WHO/HAI project on 'Medicine Prices' and has guided and completed eight surveys on medicine prices and availability in different states of India. Dr. Kotwani was the Technical

Supervisor for the two WHO surveys on "Prices and availability of children's medicines" under the project "Better Medicines for Children in India" at Orissa and Chhatisgarh.



26

In collaboration with WHO, Dr. Kotwani has developed a practical methodology that monitors antimicrobial use in the community, which is especially useful in resource-poor settings. She has also conducted qualitative studies of various stakeholders (such as physicians, chemists, and citizens) to ascertain antibiotic-use-related behaviour. The Government of India appointed Dr. Kotwani as a member of Ministry of Health task force, which is charged with assessing and proposing measures regarding antimicrobial use and resistance. Dr. Kotwani is member of National Working Group of the Global Antibiotic Resistance Partnership (GARP), India and work with them for containment of antimicrobial resistance.

Abstract

Antibiotic Overuse in India: Recommendations for ActionAnita Kotwani, Associate Professor, Department of Pharmacology, V. P. Chest Institute,

University of Delhi, Delhi, India

The increasing trend of antimicrobial resistance (AMR) has serious public health and economic implications worldwide, especially in developing countries, including India. The overall volume of antibiotic consumption or drug selection pressure is the most important cause of development of resistance in the bacteria. The reasons for drug pressure are multifactorial and involve both human and animal use.

In a number of developed countries, extensive surveillance programs have been developed to study patterns of AMR and antibiotic use. The ability to undertake such surveillance is lacking in resource-constrained settings. Moreover, antibiotics can also be obtained easily from private retail pharmacies and other informal drug vendors without a prescription. Recently, few studies were conducted in India to measure antibiotic use in the community and hospital. Overprescribing and overuse were seen in both the settings. Misuse of antibiotics was observed in acute upper respiratory tract infections and in acute diarrhoea. One of the studies indicates, 43 to 57 per cent patients with these two conditions receive an antibiotic, even though antibiotic is not required in these conditions. Resistance levels are high wherever studies have been conducted.

Antibiotic resistance and irrational use of antibiotics is a reality that needs to be tackled urgently in India. Immediate steps by the government, policymakers and regulators are needed to promote rational use of antibiotics and decrease the rapid development of AMR. Recommendations involve political commitment and establishing multidisciplinary teams to target: (1) reducing the drug pressure through rational use of antibiotics in humans, animals and agriculture; (2) reducing the need of antibiotics. Establishing a national antibiotic surveillance and resistance program is of the highest priority.

The Government of India has prepared a National Policy for Containment of Antimicrobial Resistance that covers a range of recommendations. Implementing these recommendations will help achieve the goal of rational use of antibiotics and containment of antimicrobial resistance.

Kathleen Holloway

Regional Advisor Essential Drugs and Other MedicinesWorld Health Organisation, Regional Office for South East Asia (SEARO)New Delhi, India

Dr. Kathleen Holloway is the Regional Advisor in Essential Drugs and Other Medicines in WHO/SEARO. She is a medical doctor who has specialized in general medicine, general practice and public health and has a PhD in public health. Prior to coming to SEARO in April 2010, she worked for 10 years in WHO Geneva on promoting rational use of medicines and containing antimicrobial resistance. Prior to working with WHO, she worked with NGOs for 10 years in Asia - running a small hospital on the Myanmar/Thailand border, undertaking community health with Tibetan refugees in India, coordinating



27

essential drug programmes in Nepal and also working on TB and Leprosy control in Nepal. Prior to work in Asia she worked in the UK National Health Service for 11 years - both in internal (general) medicine and in general practice.

Abstract

Promoting rational use of antibiotics - global and regional perspectivesDr Kathleen A Holloway

Regional Advisor Essential Drugs and Other MedicinesWorld Health Organisation, Regional Office for South East Asia

New Delhi, India.

Inappropriate use of antibiotics occurs globally and contributes to increasing resistance which causes significant mortality, morbidity and increased health care costs. This paper reviews the evidence on how we are promoting rational use of antibiotics globally and in the S. E. Asian region. Suggestions are made on how to go forward.

Evidence confirms that there is much antibiotic misuse and overuse, for example: (1) overuse of antibiotics in viral upper respiratory tract infection but under-use of appropriate antibiotics for pneumonia, and (2) overuse of antibiotics in acute diarrhoea cases but underuse of oral rehydration solution. Relatively few interventions have been conducted and adequately evaluated but they show that targeted multi-component interventions involving educational and managerial components are effective can improve antibiotic use by 20-30%.

Antibiotic use is heavily influenced by a country's policy framework. Globally and in S. E. Asia, antibiotic use is often not monitored and antibiotics are often available over-the-counter without prescription. Important policies to encourage appropriate antibiotic use are often not in place and most of them are aimed at the public sector, whereas most people in S. E. Asia get their antibiotics from the private and informal sectors. Thus, it is not surprising that irrational use of medicines, including antibiotics, continues.

There are now global and regional recommendations to have a government structure dedicated to monitoring and improving medicines use and to undertake a national situation analysis in order to develop a roadmap for action. WHO/SEARO has undertaken national situational analyses, at Ministry of Health request in ten countries, in order to help them develop coordinated, contextualized plans of action.

Dr. Cecilia Stålsby Lundborg, Ph.D

Professor, Head of Division, Global Health, IHCARDep of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.Email: [email protected]

Professor Cecilia Stålsby Lundborg, MScPharm, PhD is head of Division of Global Health (IHCAR), Department of Public health Sciences, Karolinska Institutet, Stockholm, Sweden. Her multidisciplinary research group focuses on various aspects of antibiotic use, antibiotic resistance, health care associated infections and also environmental aspects in relation to antibiotics and antibiotic resistant bacteria. The group uses a wide range of methods, including epidemiological, qualitative and laboratory methods. Funding is received e.g. from Swedish Research Council, EU and Sida. The research group collaborates with researchers from many countries, mainly in Asia, focusing on India. She has about 100 publications in peer reviewed international journals and has been supervisor of more than 10 doctoral

students who successfully have defended their PhD. She is involved in projects also in Sweden and is a member of the Strama 'The Swedish collaboration against antibiotic resistance' advisory group. She is scientific advisor to ReAct - Action on antibiotic resistance.



28

Abstract

Information And Interventions Needed To Preserve Antibiotics For Future GenerationsCecilia Stålsby Lundborg, Professor, Head of Division, Global Health, IHCAR,

Dep of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.

For future generations to have access to effective antibiotics we need to contain antibiotic resistance. To contain resistance we need to use antibiotics rationally and only when necessary i.e. it is not enough with rational prescribing and dispensing, unnecessary infection need to be avoided through improved hygiene. To achieve this, many individuals need increased knowledge and awareness to be able to change their behaviour. For this we need information about present behaviour and also need to develop interventions that are contextually appropriate and relevant for various target groups. Behaviour change is an individual very complex process. When we think of behaviour change in relation to antibiotics we may first think of prescribers and dispensers, but also patients and the general public need to become aware in order to take correct decisions.

In this presentation methods and results from studies mainly from Sweden and Asia will be presented and discussed. In Sweden a number of qualitative interview studies have been performed to elucidate perceptions and attitudes mainly among hospital prescribers and general practitioners (GPs) in relation to antibiotic prescribing, antibiotic resistance and hygiene. One example was that various categories of perceptions were found, among hospital physicians, here shown in order of more complex to less complex, (E) Aware, interested and competent (maintenance), (D) Aware and restrictive, but support required (action), (C) Stuck in the system (contemplation), (B) Too uncertain to be restrictive preparation, (A) Prefer effective treatment (pre-contemplation). From interviews with GPs the following categories were found, also in order of more to less complex (E Patients benefit personally from restrictive antibiotic prescribing, (D) Restrictive antibiotic prescribing can protect the effectiveness of antibiotics, (C) Restrictive antibiotic prescribing is time consuming, (B) The prescribing must meet the GPs perceived demands (personal, professional, organizational), (A) The GP must help the patient to achieve health.

Challenges in educational interventions towards professionals and the general public will be presented.

Dr. Nupur Gupta, MBBS

Consultant, GDDIC, National Centre for Disease Control, Delhi, India

Dr. Nupur Gupta is working as Consultant Microbiologist in Global Disease Detection, India Centre at National Centre for Disease Control (NCDC). She is working with Additional Director, NCDC, Nodal agency for implementing the National Antibiotic Policy.

She has done her MBBS from Maulana Azad Medical College, MD and Senior Residency from lady Hardinge Medical College.

AbstractAntibiotic Policy of India: Challenges Ahead

Gupta N, Aravindan A, Khare S, Chauhan LS Nation Centre for Disease Control (NCDC)

Ministry of Health and Family Welfare, Government of India, Delhi, India

Development of Anti-Microbial Resistance (AMR) in pathogens of public health importance is a major global and national public health problem which can lead to serious health, social, economic and disease transmission problems if not tackled timely. We may finally end up in Post-antibiotic era with very few treatment options available. The published reports in the country reveal an increasing trend of drug resistance in common diseases of public health importance i.e. Cholera: showing high



29

level of resistance to commonly used antimicrobials e.g.Furazolidone(60-80%), Co-triamoxazole (60-80%) and Nalidixic Acid (80-90%), Enteric fever: Chloramphenicol, Ampicillin, Co-triamoxazole (30-50%), Fluoroquinolones (up to 30%), Meningococcal infections: Co-triamoxazole, Ciprofloxacin and Tetracycline (50-100%), Gonococcal infections: Penicillin (50-80%), Ciprofloxacin (20-80%). A National task force had been constituted by M.O.H. &.F.W during August 2010 to frame national policy for containment of AMR in the country. The same has recently been finalized and approved by MOHFW. The proposed action plan would be focusing on implementation of various Task Force recommendations for containing AMR.

The main features of the policy are:

* To develop and enforce regulations limiting over the counter purchase of antibiotics* To ensure quality of antibiotics available in the market for public consumption* To control and monitor promotional activities carried out by various pharmaceutical companies in order to boost the sale of certain antimicrobials* To generate quality country data on antimicrobial resistance in pathogens of public health importance* To generate hospital based and community based data on usage of different antimicrobials in the country* To regulate the use of antimicrobials in non human sector eg agriculture, veterinary and industrial sector* To ensure infection control measures in different health care settings and * To strengthen laboratories for diagnosis of infectious diseases as well as for AMR surveillance.

Considering the growing concern about public health implications of AMR, a comprehensive national program for its containment is the need of the hour in our country and the same is under consideration for 12th Five Year Plan.

Prof. (Dr.) B. P. Srinivasan, Ph.D

Director, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)University of DelhiGovernment of NCT of DelhiPushp Vihar, Sector-3, New Delhi-110017

Director & Professor of Pharmacology at Delhi Institute of Pharmaceutical sciences and Research, University of Delhi. He has about 35 years experience in Research and Teaching experience in the field of Pharmacology. Dr. B.P. Srinivasan received his Ph.D from Goa University, 1996. He is currently involved in pharmacological research with major interests in the area of Diabetic and its complications, Respiratory Pharmacology and Pharmacoepidemiology. He is a chairman of IAEC, DIPSAR, Member-AICTE, PCI and also Member of IAEC at Jamia Hamdard, New Delhi. Member Secretary- Institutional Committee on Clinical Trials for DIPSAR and Member of the Committee for selection of common wealth fellowship 2008. Under Ministry of Human Resource Development (HRD), Govt. of India. He serves in

several scientific sessions as a Chairman and Co-chairman. He has done more than 40 publications in the esteemed National & International Journals.



30

Dr. Pramil Tiwari, Ph.D

Professor & Head, Dept of Pharmacy Practice,NIPER, Mohali, Chandigarh

Prof. Pramil Tiwari heads the department of Pharmacy Practice at NIPER in Mohali since its inception in 2002.

After completing M. Pharm. from the prestigious Banaras Hindu University, he served for 5 yrs at the Sardar Patel University in Gujarat. During this time, he was awarded the "Verma Memorial Prize" for the best paper presentation in 1991 at the Indian Pharmacological Society zonal conference. In 1992, he undertook a full time studentship to pursue his Ph.D. in Pharmacology - which he completed in a record period of 27 months.

Between 1994-1997, Dr. Tiwari worked as "Development Scientist" at Dabur Research Foundation where he handled the Clinical Trials and Medical Research Division. In 1997, he moved over to Amman University to pursue his interests in education & research. Having worked at university until 2002, Dr. Tiwari was appointed as Associate Professor to establish the department of Pharmacy Practice at NIPER, Mohali.

So far, he has supervised 73 M. Pharm. & 2 PhD students in Pharmacy Practice. With over 40 papers and 2 book chapters, his team is very active in emerging areas of pharmacy.

He has been actively involved in national issues like revision of the NLEM, Indian formulary and several other assignments with the ministry of health of India.

A life member of IPA, IHPA, SOPI, FIP, IAG and other forums, he was recently elected as the Joint Secretary of SPOR-India chapter for 2012-2014 period.

Abstract

Costs & Outcomes of Hospital acquired infections in Indian SettingProf. Pramil Tiwari, Head, Department of Pharmacy Practice,

National Institute of Pharmaceutical Education & Research {NIPER},S A S Nagar, Punjab, INDIA 160062

Congregating a large number of patients under a single roof facilitates the transmission of infectious diseases. If the patient is immunocompromised or has an inserted medical device, the chances for developing an infections increase manifold.

Approximately 5% of hospitalized patients experience a hospital acquired infection. Hospital acquired infection (HAI), according to the Center for Disease Control guidelines, is a localized or systemic condition 1) that results from adverse reaction to the presence of an infectious agent(s) or its toxin(s) and 2) that was not present or incubating at the time of admission to the hospital.

This is an important public health problem in developing countries as well as in developed ones. HAI is considered as a major cause of high morbidity, mortality and economic consequences in hospitalized patients.

At any time, over 1.4 million people worldwide suffer from complications of infectious acquired in hospital. The hospital acquired infections could lead to any one or more of these: Functional disability and emotional stress to the patient, increased morbidity (serious consequences and permanent disability), prolongation of hospital stay is the major extra cost.

Developed countries have established standardized criteria for the surveillance and control of HAIs. Conversely, in developing countries, lack of reliable results poses a challenge to providing information related to cost and surveillance of HAI using standardized definitions. The discussion would revolve around cost and outcomes of hospital acquired infections in Indian settings.



31

Dr. Subhash Chandra Mandal, Ph.D

Executive Council Member, ISPOR-India ChapterDept.of Pharmacy, J.C.Ghosh Polytechnic, Kolkata, India [email protected] [email protected]

Dr. Subhash C. Mandal has completed his M. Pharm & Ph.D in Pharmacy degree from Jadavpur University, Kolkata, who Co-authored 9 Books, one of which has been published by Americal Chemical Society (ACS), USA and the latest one by informa Healthcare, USA in the year of 2010. He has in his credit 50 publications in different International Journals. He has made 87 scientific presentations at different national and international conferences. Dr. Mandal started his career as a teacher and have experiences in Industry and regulatory affairs. Presently he is serving the Directorate of Drugs Control, Govt. of West Bengal for more than 20 years. Dr. Mandal has visited USA, China, Thailand and Bangladesh and presented his research works in several

conferences and workshops like- 2nd ICIUM, Regional workshop of PMNCH, DIA Annual meeting. He has served in several important committees and taskforces formed by different Govt. and International agencies. Dr. Mandal is a member of Editorial Board and reviewer of several Journals of international repute. He is an examiner of several Universities like- JU, WBUT, Vidyasagar University etc. Dr. Mandal is serving the Board of Studies of Dept. of Pharmaceutical Technology, Jadavpur University as an external member. Dr. Mandal is one of the founder members of ISPOR-India Chapter and continuing as an Executive Council Member of ISPOR-India Chapter. Dr. Mandal is also active in some other organizations like-IPA, IPS, FIP, DIA etc. Presently Dr. Mandal is the Associate Secretary of IPA, Mumbai and the Vice President of IPA, Bengal Branch. Dr. Mandal has been Awarded Fellowship Award by IPA in the year of 1999 for his outstanding contribution to the pharmaceutical profession.

Abstract

Impact of Policy Changes In Approval Of New Drugs In India And Its Impact On Access1 2Subhash Chandra Mandal , Moitreyee Mandal

1 2Executive Council Member, ISPOR-India Chapter; Dept.of Pharmacy, J.C.Ghosh Polytechnic, Kolkata, India; [email protected] subhash.mandaldr{at}gmailcom

Problem Statement: As per the report of WHO about 50-65% of Indian population have no access to essential medicines. It has been felt that new drug (NME) approval may improve the situation. Several policy changes have impact on the entry of new drugs. Different schools of thought exist in this issue. One of them believes that more protection would encourage new invention and the other believes that more protection will make medicines costlier, resulting in lower accessibility. So an analysis on the registration of NMEs by Central Drugs Standard Control Organization (CDSCO)-the approving authority of India during pre IPR and post IPR regime may give some indication, in this issue.

Objectives: To evaluate the impact of policy changes in India during 1988- 2009 on registration of new drugs in India.

Setting and population: Data on new drugs registered during 1988-2009 was collected from the documents published by CDSCO. Entire duration was divided into three phases- First- Introduction of Schedule Y and pre IPR regime i.e. 1988-2004, second- post Intelectual Property Regime (IPR) and preammended Schedule Y regime i.e. 1995-2004 and third-Post IPR and amended Schedule Y regime i.e. 2005-2009. 639 NMEs except veterinary use were approved during 1988-2009 were considered for this study.

Policies: IPR related policies -like signing in WTO agreement, implementation of amended Indian Patent Act 2005 with effect from 1st January 2005 and introduction of Schedule Y in Drugs Rules in 1988 and amendment of Schedule Y in 2005.



32

Outcome measures: Average number of drugs approved during these three phases, prevalence of therapeutic categories, number of drugs for neglected tropical diseases approved, and possible impact on access of medicines.

Results: During this 22 years i.e. 1988-2009 total 636 NMEs approved with an average of 29.04 (SD. 8.88), which is considered quite high in number. In the first phase i.e. 1988-1994 total 147 NMEs were approved (Ave. 21, SD. 4.04). In the second phase i.e. 1995-2004 total 316 NMEs were approved (Ave. 31.6, SD. 9.16) and in the third phase i.e. 2005-2009 total 176 NMEs were approved (Ave. 35.2, SD. 4.86). During all three regimes CNS NMEs were highest followed by Antimicrobials and cardiovascular. It has been noted that no drugs for neglected tropical diseases were approved except 6 antimalarials and 2 Antileishmanial drugs. Average number of NMEs approved showed a quantum leap during 1995-2004 which may be due to the expectation of the promoting companies for better IPR protection leading to high profit. It has also been noted that there is an upsurge during 2001-2003. This may have been because the promoters were in a hurry to take advantage of process patent before introduction of Product Patent, effective from 01.01.2005. The third phase showed increment in average number approved but less in comparison to the 2nd phase, which may be due to relaxation allowed in Schedule Y, which is partially neutralize by implementation of Product patent in India.

Conclusions: Implementation of IPR, amendment of Patent Act allowing product patent, and amendment of Schedule Y giving more flexibility to the clinical investigators showed a mixed result in introduction of NMEs. Though number of NMEs introduced is high in general throughout this 22 years period but drugs for neglected tropical diseases were mostly ignored resulting no tangible improvement of access to medicines in India.

Dr. D. P. Pathak, Ph.D

Professor & Head, Department of Pharmaceutical ChemistryDelhi Institute of Pharmaceutical Sciences and Research (DIPSAR)University of DelhiGovernment of NCT of Delhi

Pushp Vihar, Sector-3, New Delhi-110017

Dr. D P Pathak is presently working as Professor & Head Dept. of Pharmaceutical Chemistry, Delhi Institute of Pharmaceutical sciences and Research (DIPSAR), University of Delhi. Dr Pathak received his Ph.D from Punjab University, Chandigarh in the year 1988 and master degree from Banaras Hindu University in the year 1981. He has 30 years of Research and Teaching experience in the field Pharmaceutical Chemistry. He is recipient of various awards and merits. He has served on the panel of inspectors of AICTE and PCI. He has received many research grants from Govt. funding agencies like UGC, AICTE. Dr Pathak has been invited speaker at many national symposiums, workshops and conferences. Dr

Pathak has more than 60 publications to his credit in National & International Journals. Dr Pathak is co-coordinator Coordinator, National Pulse Polio Immunisation programme for Saket and Ambedkar Nagar Constituency, New Delhi.



33

Dr. Bikash Medhi, MBBS, MD (AIIMS),MAMS,FIMSAAdditional Professor & Joint Medical Superintendent,Coordinator PGIMER Pharmacovigilance CentreDepartment of Pharmacology, Research Block B, Room No 4043 ,PGIMER, Chandigarh

Dr. Bikash Medhi is Additional Professor & Joint Medical Superintendent, Coordinator PGIMER Pharmacovigilance Centre Department of Pharmacology, PGIMER, Chandigarh. He did MBBS from Assam Medical College (AMC), Dibrugarh University, Assam, India in 1992 and M.D. Pharmacology from All India Institute of Medical Sciences, New Delhi in 1997. He was Elected as Fellow of International Medical Sciences Academy(FIMSA) in 2006 and Awarded Member of National Medical Academy (MAMS) 2009.

He was Awarded Dr.B N. Ghosh Oration at 43rd Annual Conference of IPS. Member of Investigational New Drug ( IND committee, DCGI office, Ministry of

Health, Nirman Bhawan, Government of India.

He is Secretary Clinical Pharmacology of Indian Pharmacology Society and was selected as Core panel expert for Task Force to frame guidelines for submission of dossiers or proposals for regulation of biotech products (r-D~A product), Govt of India, Ministry of Health and Family Welfare, New Delhi in 2011. He was Core member of Expert committee Compensation Guideline Govt of India, Ministry of Health and Family Welfare, New Delhi in 2011. He is member of many national and international societies. He was awarded many travel grants to attend international conferences. He is also member of editorial board of many journals. He has authored many chapters in books and has about 140 publications in national and international journals.

Dr Medhi has been trained as GLP inspector by DST and is Coordinator for PGIMER Pharmacovigilance Centre. He has guided about 30 students and has five extramural projects.

Abstract

Causality Assessment of Adverse Drug EventBikash Medhi, Rakesh Sewal

Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India

Causality assessment is the establishment of relationship between the drug exposure and the adverse event. Causality assessment gives an answer to the question: To what extent the drug is responsible for the adverse event? Causality assessment demarcates the adverse drug reactions from adverse events. Causality assessment involves a complex procedure to reach up to any single level of the scale. There are several methods being adopted by the Pharmacovigilance community across the globe. These many methods have been developed in an attempt to do structured and harmonised assessment of causality. Every method has its own pros and cons and none of the methods has been shown to produce a precise and reliable quantitative estimation of relationship likelihood so far. The relationship of an individual case-report can be established, but it may not be possible to establish a firm opinion on causality until a collection of such reports is assessed or new knowledge is gained. The ultimate goal of assessment of each event, or a cluster of events being treated as a signal. WHO's causality assessment scale, Naranjo's scale, Bayesian Probability method, methods described by Karch and Lasagna, Kramer et al, Emanueli and Sacchetti, Jones, Kitaguchi et al., Begaud, Maria and Victorino, Danan and Benichou are few methods to state here. WHO's scale and the Naranjo's Scale are the most widely used methods for causality assessment in clinical practice as they offer a simple methodology. For reporting SAE following causality assessment one need to follow the national regulatory guideline. In future there is more need to reform the existing methods to make more robust and precise causality assessment so that a non-erroneous conclusion can be drawn from Pharmacovigilance data as till now we do not have the gold standard.

Key words: Pharmacovigilance, Adverse Drug Event, Causality Assesment



34

Dr.T.P. Singh, Ph.D

Distinguished Biotechnology Professor,Department of Biophysics, AIIMS, New DelhiEmail : [email protected]

Dr T.P. Singh is Distinguished Biotechnology Research Professor, Dept of Biophysics, AIIMS. He did post graduation from University of Allahabad and Ph.D. from Indian Institute of Science, Bangalore in 1975 on Structure-Function Studies of Analgesic/anti-inflammatory agents. He was Professor and Head of the Biophysics Department from 1986 to 2006. He was Alexander von Humboldt / Max-Planck, Post Doctoral Fellow of Max-Planck Institute for Biochemistry, Martinsried, Germany from 1978-80. He has been awarded fellowships of Third World Academy of Sciences (F.T.W.A.S.), Indian National Science Academy (F.N.A.), National Academy of Sciences, Indian Academy of Sciences, Alexander von Humboldt Foundation, Biotec Research Society of India. He was awarded Doctor of Science, D.Sc. (h.c.) by Karnataka State

Open University, Mysore in 2010

He is the recipient of many prestigious awards such as 56th Foundation Day Oration award of Agharkar Research Institute (DST) Pune, 2012, Bhramara's Y T Thathachari award in Life Sciences, Mysore 2012, Jawaharlal Nehru Birth Centenary Lecture Award of INSA - 2011, Annual Award of the Instrumentation Society of India - 2011, CSIR Foundation Day Lecture award - 2010, Professor G.N. Ramachandran CSIR Gold Medal for the Excellence in Biological Sciences and Technology - 2006, Professor G.N. Ramachandran 60th Birthday Commemoration INSA Medal - 2006, Sir J. C. Bose Memorial Award of the Indian Sciences - Congress - 2006, Humboldt - Foundation Award - 1990, Danish International Development Agency Award - 1978 etc.

He is the Chief Editor, Proceedings of INSA, New Delhi for the period 2010 to 2013 and President, Indian Crystallographic Association 2010 - 2013. He has guided 72 students, has 386 publications and 465 protein structures to his credit.

His fields of research are Structural Biology, Peptide Design, Drug Discovery and X-ray Crystallography.

Abstract

Innate Immunity Proteins As Therapeutic Agents Against Bacterial InfectionsPradeep Sharma, Mau Sinha, Punit Kaur, Sujata Sharma and T.P. Singh

Department of Biophysics, All India Institute of Medical Sciences, New Delhi

The proteins of the innate immune system provide the first line of defense against infecting microbes. These proteins recognize the conserved motifs that are present on the cell walls of microorganisms but are absent in those of host organisms. Thus the success of innate immunity system depends on this aspect of discrimination between pathogens and self. The conserved motifs of microbial cell walls are called pathogen associated molecular patterns (PAMPs) that include the well known peptidoglycans (PGN) and lipopolysaccharides (LPS) of Gram-negative bacteria, PGN and lipoteichoic acid (LTA) of the Gram-positive bacteria and mycolic acid (MA) and other fatty acids of Mycobacterium tuberculosis. These PAMPs are classified into two groups: (i) those which contain glycan moieties such PGN, LPS, LTA etc. and (ii) those that are derivatives of fatty acids such as MA. These PAMPs are specifically recognized by innate immunity molecules historically known as peptidoglycan recognition proteins (PGRPs) which bind to PAMPs with high affinities and neutralize the infecting pathogens through variety of actions. There are four types of PGRPs in mammals including humans, PGRP-L (MW = 90 kDa), PGRP-Ia and Ib (MW = 45 kDa) and PGRP-S (MW = 21kDa). The concentrations, structural organizations and potencies of these proteins differ from species to species. We have observed novel properties of the PGRP-S which is expressed in the mammary gland of Camelus dromedarius. The



35

concentration of this protein goes up considerable during the infectious disease of mastitis which is manifested as the inflammation of the breast tissues. The concentration of this protein is relatively low in humans. It is perhaps to compensate for the peculiar adaptive immune system in camels. In order to understand some of the peculiar properties of the camel PGRP-S (CPGRP-S), we have determined the structures of unbound and PAMP-bound CPGRP-S.The structure determinations show that CPGRP-S adopts a novel quaternary structure forming a linear polymer in which two opposite faces A and A' of a monomer associated through the opposite faces A' and A respectively of the other two monomers thus forming a linear polymer with two unique molecular contacts called as A-A' and A'-A which repeat in the chain alternatingly. We have carried out extensive binding studies and determined the structures of several complexes of CPGRP-S with a number of PAMPs including LPS, LTA, PGN, MA etc. The binding studies showed high affinities with binding constants having nanomolar values while structural studies revealed that the cleft at A-A' was specific to PGN, LPS and LTA while that at A'-A was favourable for the binding of fatty acids.The two binding site are independent of each other. The modes binding at the two sites involve interactions from both molecules A and A' leading to the sequestration of bacteria. In a contrast, the monomeric human PGRP-S (HPGRP-S) lacks the comparative binding power. The comparison of amino acid residues of CPGRP-S with those of other species indicated that all of them are likely to be monomeric similar to that of HPGRP-S. Thus CPGRP-S is a far better binding protein than those from other species. The mechanism of action involves an effective sequestration of bacteria by CPGRP-S leading to its killing. Since CPGRP-S interacts essentially with bacterial cell wall, the kinetics of bacterial cell death may be considered as resembling with those of antibiotics such as penicillin. Due to this similarity, CPGRP-S could be termed as a protein antibiotic.

Dr. Sudershan Arora, Ph.D., D.Sc.

President, R&D, Ranbaxy Laboratories Ltd., Gurgaon

Dr. Sudershan K. Arora has over 32 years of extensive experience in Drug Discovery, Pre-clinical and Clinical Development of New Chemical Entities, Development of Generic Drugs comprising a wide range of technology driven immediate release dosage forms & Novel Drug Delivery Systems and development of non-infringing, commercially viable and complex technologies for a wide range of Active Pharmaceutical Ingredients. He also has good understanding of emerging technologies in API like Asymmetric synthesis, Biocatalysis, Reaction Calorimeter and Peptides. He is well versed with Global Regulatory, Intellectual Property, Clinical Pharmacology and Pharmacokinetics Units, Compliance and Quality requirements. Dr. Arora is also responsible for research and manufacturing of Biosimilars and vaccines.

Dr. Arora has worked with many leading Indian and global pharmaceutical companies like Greenwich Pharmaceuticals Inc. USA, Medicarb Inc. USA, Biogen Inc., USA, Lupin and Sandoz, Austria.

With a Ph.D in Synthetic Organic Chemistry from Kurukshetra University and a D.Sc. in Pharmacokinetics and Toxicology from Bundelkhand University, Dr. Arora has been a prominent speaker at various national and international scientific forums. He is also on the governing bodies of numerous academic and research institutions in India. He is a member of the Board of Directors of several subsidies of Ranbaxy Laboratories Ltd.

He has 46 publications in reputed journals and more than 40 Patents to his credit.

AbstractClinical Development of an Antimalarial Drug

Dr. Sudershan AroraPresident, R&D, Ranbaxy Laboratories Ltd., Gurgaon

Ranbaxy Research Laboratories has developed a fully synthetic new chemical entity, Arterolane



36

maleate. Arterolane has undergone rigorous screening and has been found to be effective and safe in preclinical studies. Phase I and Phase II clinical trials conducted with arterolane maleate have shown that the drug is safe for use in humans and has a wide therapeutic margin. The pharmacodynamic studies demonstrated that the drug is rapidly acting and clears parasites from the blood effectively in the malaria patients.

The development program of arterolane maleate envisages a fixed dose combination of rapidly acting arterolane maleate with long acting piperaquine phosphate (PQP), a bisquinoline antimalarial drug, in accordance with the recommendations of WHO for the treatment of malaria. The tolerability, efficacy, pharmacokinetic profile and low cost of piperaquine make it a promising partner drug for use with arterolane maleate.

Prof. Balram Airan, MBBS, MS, M.Ch.

Chief, Cardiothoracic Center, Head, Cardio-Thoracic Vascular Surgery, AIIMS, New Delhi

Dr. Balram Airan is presently working as Professor & Head, Deptt. of CTVS & Chief, Cardiothoracic Centre, All India Institute of Medical Sciences,New Delhi. Dr. Balram is the one of the top cardiac surgeon of the country. Dr Balran has trained 135 M.Ch (CTVS) students and 16 others are under training. Dr Balram has Performed more than 20000 operations and associated with another 2000. The variety includes coronary/ Valvular/congenital heart diseases including Cardiac Transplant, LVAD implants, Batista procedure, OPCAB and various complex Cardiac lesions.

As a cardiac surgeon, he has been actively involved in operating upon the patients with various types of lesions and some of them for the first time in India. He was an active member of the surgical team which carried out first successful cardiac transplants in India, implantation of ventricular assist devices and successful Batista's procedure for chronic cardiac failure.

As a Cardiac surgeon, Dr Balram has performed more than 20000 operations. The diseases for which open-heart surgery was performed included CAD in 15% cases, valves 35% cases & congenital heart diseases including complex lesions such as Arterial switch operation, TAPVC, Truncus arteriosus and Univentricular heart repair in 40% and miscellaneous 10%. He performs various types of non open-heart procedures also including thoracic and vascular surgery. Besides these, He was also associated with another about 2000 cases. Besides surgery, I attend to about 2000 cases/year in the cardiac clinic.

He has been invited speaker at many national and international conferences and symposiums. He has got several publications to his credit.

Abstract

Stem Cell Therapy for Cardiovascular DiseasesProf. Balram Airan,

Chief, Cardiothoracic Center, Head, Cardio-Thoracic Vascular Surgery All India Institute of Medical Sciences, New Delhi. India

Stem cells, the foundation of all life forms have remarkable potential which gives rise to different cell type right from the early life to the adult form. Stem cells are of two types: Embryonic stem cells (ESCs) and adult stem cells (ASCs). These ESCs are derived from early stage embryo and have the highest plasticity. However, the ethical concerns limit their potential to be exploited in clinical application. On the other hand, ASCs are undifferentiated cells, found in almost every organ. These ASCs have an edge over the ESC because the use of adult stem cells does not raise ethical issues. These adult stem cells are the oldest known stem cells in the clinical practice. The autologous bone marrow derived stem cells are into clinical trials at different centers in India and abroad.



37

AIIMS is one of the major centers in India to have involved in clinical trials of autologous bone marrow derived stem cells (BMSCs). The stem cell clinical trials in which AIIMS is involved include myocardial infract, dilated cardiomyopathy, critical limb ischemia,

Dr. Satish Bhatia, Ph.D

ConsultantClinical Development Service AgencyDepartment of Biotechnology, Govt of India470 Udhyog Vihar, Phase III, Gurgaon - 122 016, Haryana (INDIA)

After 30 years of international experience in pharmaceutical R&D, Dr Satish Bhatia is now a consultant with the Clinical Development Services Agency (CDSA) of the Department of Biotechnology, Govt of India. He was associated with Ciba-Geigy (Novartis) for 17 years in various positions in their R&D labs in Switzerland, India and USA. While in India, he was an integral part of the team from early discovery through proof-of-concept clinical trials at Ciba-Geigy's research centre in Mumbai specializing in tropical diseases. In New Jersey, USA he was a core member of 'Other Therapeutic Areas' group dealing with cancer and metabolic diseases, and Business Development Cell for in-licensing of new molecules. On his return from the US in 1995, Dr Bhatia has

served the Indian pharmaceutical industry by establishing a GCP centre of excellence in clinical pharmacology and pharmacokinetics at the Ranbaxy R&D laboratories in Gurgaon, and then, two start-up CROs - Wellquest (now Piramal Clinical Research) in Mumbai and Fortis Clinical Research Ltd in Faridabad. Following his PhD in Biochemistry from the University of Delhi, Dr Bhatia held faculty positions at the University of Geneva in Switzerland. His interests include clinical and preclinical drug development, pharmacokinetics, GLP/GCP-based bioanalytics and proof-of-concept clinical trials, quality assurance, business development and mentoring.

AbstractTowards Enhanced Clinical Development for India's Needs

Dr Satish Bhatia, Consultant, Clinical Development Service Agency,Department of Biotechnology, Govt of India

Clinical Development Services Agency (CDSA) has been formed as a not-for-profit society to facilitate development of affordable healthcare products primarily for public health diseases. CDSA, as an extramural unit of Translational Health Science and Technology Institute (THSTI) of the Department of Biotechnology, Government of India, will facilitate supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions. It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases such as malaria, tuberculosis and dengue among others. The modalities, services and aspirations of CDSA will be discussed during the presentation.

Dr. Divya Mishra, MD

Therapy Lead Oncology and Clinical Development Pfizer Limited, Mumbai

Dr. Divya Mishra obtained an MD in Radiation Oncology from University of Allahabad and postgraduate certification in Clinical Pharmacology, Drug Development and Regulation from TUFTS University in Boston. She is a member of AROI, ASCO, ESMO and ISCR and has an avid interest in clinical and outcomes research. She has an overall industry experience of 5 years at Pfizer in driving medical strategic planning for Oncology business at both local and regional (Asia, EURIT) levels. She is currently also leading the local clinical development and Outcomes research portfolio for Pfizer India.



38

AbstractHealth Economics and Outcomes Research: An OverviewThe What & Why of Systemic Reviews and Meta Analysis

Divya Mishra

Health care providers, researchers, and policy makers are inundated with unmanageable amounts of information, they need to efficiently integrate existing information and provide data for rational decision making. This 2 hour session will help to provide the audience with a broad overview and applications of health economics and outcomes research, the terminologies used therein, including an orientation to the relevance and conduct of systematic reviews and meta analysis.

Dr. KK Sharma, MD, FAMS

Professor & Head, department of Pharmacology, School of Medical sciences & Research, Sharda University, Greater Noida, UP, IndiaFormer, Professor and Head, Deptartment of Pharmacology, University College of Medical sciences & GTB Hospital, Delhi

He is a reputed teacher with more than 40 yrs of teaching experience to UG & PG's. He is also worked a associate Professor of Pharmacology, Faculty of Medicine, Al-Fateh university, Libya & has been visiting professor of Pharmacology at B.P. Koirala Institute of Health Sciences, Nepal. He has been a member of expert advisory committee to frame syllabus & curriculum for UG & PG courses for various Indian Universities, B.P. Koirala Institute of Health Sciences, Dharan, Nepal & Medical council of India. He has published over 150 scientific papers in both National & international journals. He has won several awards and distinctions such as IUPHAR Travel fellowship award (1984), Indo USSR Co-Operation in medical Sciences Research award

(1988), Indo-USSAR travel fellowship (1990), distinguished teacher award from UCMS Alumi Associations (1994), Fellowship of Indian Pharmacological Society (2004), Sir Shriram Memorial Oration Award of the National Academy of the medical sciences India (2004-2005) & Professor Govind Achari Oration Award (2006-2007) of Indian pharmacological Society.

Javed Shaikh, M.Pharm

Consultant-Health Outcomes Research, Capita India Pvt. Ltd.

Javed is a Consultant-Health Outcomes Research at Capita India Pvt. Ltd. He has worked on a range of HEOR/Market Access /Medical communications projects across several disease areas. In his previous role at Heron Health Pvt. Ltd., Javed worked on more than 50 systematic reviews (both clinical and economic) across various disease areas including oncology, neurosciences, rheumatoid arthritis, diabetes, obesity, osteoporosis, immunology, and infectious diseases. He has the skills to analyse large volumes of qualitative and quantitative health care data, expertise in developing and validating search strategies for different biomedical

literature databases. He has successfully solved and won one of the prestigious InnoCentive challenges in life sciences. He is also active member in ISPOR Asia Consortium. Prior to this, Javed received a Masters' degree in Pharmaceutics from the National Institute of Pharmaceutical Education and Research (NIPER), India. During his post-graduate study he was involved in a research project based on the application of Nanotechnology in advanced drug delivery. His studies also included fundamental aspects of drug metabolism and pharmacokinetics, dosage form development parameters, drug product development, biomaterials, solid state pharmaceutics, pharmacological screening, pharmaceutical biotechnology, and biostatistics. During his curriculum, he developed skills in various analytical and microscopic techniques. This has helped him develop a comprehensive understanding of the drug discovery and development process. In addition to working on client projects, he has also contributed research to conferences such as ISPOR, and also involved in editorial activities with reputed international journals.



39

Mahendra Rai, M.Pharm

Senior Consultant, HEOR.

Mahendra is a Senior Consultant-Health Outcomes Research and has worked on a range of Market Access projects including value demonstration and medical communications. In his previous role at Heron Health, Mahendra worked on all stages of clinical and economic reviews ranging from background research to final deliverable to the clients. He has considerable expertise in the development of search strategies, report writing, performing meta-analysis and writing manuscripts for peer-reviewed journals.

He has worked on projects in several disease areas including: oncology (colorectal cancer, breast cancer, non small cell lung cancer, prostate cancer, and non Hodgkin's lymphoma), neuroscience (depression, schizophrenia), diabetes and autoimmune disorders (SLE, rheumatoid arthritis, multiple sclerosis, and fibromyalgia), overactive bladder, venous thromboembolism, HIV and other viral diseases. In addition to working on client projects, he has also contributed research to conferences such as ISPOR.

Prior to this, Mahendra studied for his Masters in Pharmacy at the University of Delhi. As part of his post-graduate research he was involved in the formulation and clinical development of a gel for prevention of HIV/AIDS and cervical cancer in women. He has also worked as a Senior Research Associate at a Scientific and Industrial Research Organization (SIRO) in India and as Assistant Manager - Medical Affairs in an Indian multinational company. Mahendra's total experience in pharma industry is more than 7 years including over 5-years in healthcare consultancies.

Dr. R. K. Jalali

Vice President-Medical Affairs & Clinical ResearchHead-Global Pharmacovigilance, Ranbaxy Laboratories Ltd., India

Dr. R. K. Jalali is an Internist by background. In his current position, he is working as Vice President, Medical Affairs & Clinical Research and Head Global Pharmacovigilance at Ranbaxy Laboratories. He is responsible for providing strategic direction and effective management of Global Pharmacovigilance Operations at Ranbaxy. Dr. Jalali has also an extensive experience in designing and executing Phase I to Phase IV clinical trials in various therapeutic areas. He is Member Governing Council and In Charge Operations of Ranbaxy Community Healthcare Society which is engaged in providing preventive, promotive and curative healthcare services to the community, as part of Corporate Social Responsibility, in about 345 rural and urban slum areas in Punjab, Haryana, Himachal Pradesh, Madhya Pradesh and Delhi with focus on reducing infant mortality, improving maternal health and combating HIV/AIDS, tuberculosis, malaria, other neglected diseases in line with Millennium Development Goals (MDG) set forth by the United Nations Development Program (UNDP). As Member Governing Council of Ranbaxy Science Foundation, Dr. Jalali is responsible for organizing Symposia and Conferences in diseases of public health importance in India. Dr. Jalali is also a Member of Biotechnology Forum of Federation of Indian Chambers of Commerce and Industry (FICCI).

Abstract

Basic Concepts, Signal Detection And Signal ManagementR. K. Jalali, Vice President-Medical Affairs & Clinical Research

Head-Global Pharmacovigilance, Ranbaxy Laboratories Ltd., India



40

The clinical science and its needs have evolved at a tremendous pace in last thirty years. The focus earlier was on having effective medicines, as understanding of some of the diseases and their prospective cure was developing. Now that effective medicines are available for most of diseases affecting masses, the spotlight is on drug and patient safety. This change of focus is also because gaps with respect to drug safety still remain in the pre-marketing drug development. The adverse events associated with the drugs have implication on all stakeholders viz. public, pharmaceutical companies and regulators. The referred impact is easily evident from review of the available data. To mitigate this impact there is growing emphasis on early detection of safety signals and their appropriate management. Regulators and pharmaceutical companies have already responded to this need by coming up with new regulations, guidelines and working groups e.g. CIOMS working group VIII and its report in 2010, EMA GVP modules in 2012. Though paradigm shift from earlier main stay areas of pharmacovigilance such as case processing and PSURs towards safety signal and risk management has started in last few years, signal management has been evolving over last couple of decades from traditional methods of case reviews to application of complex quantitative methods to the safety databases. There is, however, no single method of signal detection which can cater to all needs. Therefore, there is a requirement to adopt customized strategies towards signal detection. Also, ambiguity of threshold selection in signal detection is one challenge that is being worked upon by the drug safety scientists and will remain area of focus for next few years. Overall, signal detection, its methods and its management, is much more clearly placed in the regulations now than before. This talk provides an overview of all these areas related to safety signals.

Moin Don

Executive Director& Founder PVCON Pharmacovigilance Auditing Consulting Services, Mumbai.

Moin has over 33 years experience in the pharmaceutical industry. Pharmacist by education, Moin is one of the most well known 'Pharmacovigilance Professionals' in India. He has rich hands on experience of practically every facet of Industrial Pharmacovigilance, while serving reputed international pharmacos like Sanofi Aventis & his last assignment being with Johnson & Johnson as Regional PV QA Director for Asia Pacific. Moin has undergone extensive training in U.S, Germany, France & Singapore and is a certified 'Lead Auditor'. He is one of the co-author in developing the protocol for 'India's

National Pharmacovigilance Program'. In addition Moin is also a member of the Central Advisory Committee of DIA India. He is a visiting faculty & international speaker & author whose articles have been published in international journals of repute.As a distinguished PV consultant &auditor, Moin has conducted audits in India & rest of Asia Pac region besides helping pharma companies in establishing PV systems.

Topics: 1. Assuring Quality in Pharmacovigilance System

2. Audits and Inspections in Pharmacovigilance

Dr. Manoj Sharma, Ph.D

Manoj Sharma is a Ph.D in pharmacology with a specialization in pharmacovigilance and pharmacoepidemiology from University of Bordeaux, France. He has more than 10 years of industrial experience in pharmacovigilance and clinical research. In 2009 he has been awarded a prestigious "Sandwich Ph.D" fellowship by Ministry of Science and Technology, Govt. of France to carry out advanced pharmacovigilance research in University of Bordeaux, France. He has co authored books entitled "Essentials of Pharmacovigilance" and 'Role of Pharmacovigilance in Clinical



41

Research' and has published 14 research papers in international journals.He has been awarded grants by International Society of Pharmacoepidemiology, USA and Indian National Science Academy for presentation of original research papers in international conferences.

He has been a recipient of certificate on "Qualified Person for Pharmacovigilance (QPPV)" by WHO and EMEA endorsed 'International Society of Pharmacovigilance'. His areas of interest include vaccine pharmacovigilance, risk management plans and clinical research.

Abstract

Role of Pharmaceutical Industry for Drug Safety in New MillenniumDr Manoj Sharma

Pre marketing studies (Phase I, II, and III trials) are conducted in controlled situations with selected groups of people. Though a new drug appears to be safe in these studies, unseen adverse effects can occur when a drug is released for use in general population in 'real world clinical practice'. (1)

Pharmaceutical industry has the obligation for continuous monitoring of the products once a marketing authorization is granted. Surveillance in the post marketing phase is conducted to continuously analyze benefit / risk ratio.

The surveillance activities usually include the collection, reporting, and evaluation of adverse experience reports: the analysis of drug use data to calculate reporting rates; and the conduct of epidemiologic and other studies to better quantitate the public health importance of these events.

In a pharmaceutical industry the aims and objectives of carrying out the post marketing surveillance include: the safety of patients from unnecessary harm by identification of previously unrecognized drug hazards (safety signals) and quantification of risk in relation to benefit.

A Periodic Safety Update Report (PSUR) (3) which is one of the important tool used as a PMS activity is intended to provide an update of the worldwide safety experience of a medicinal product by the Marketing Authorization Holder to Competent Authorities/Regulatory Authorities at defined time points post-authorisation. At these times, Marketing Authorisation Holders are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new or changing information.

No single method in PMS can be relied upon to answer all questions that may be posed for defining the risk benefit profile during post authorisation. Each method answers a particular need and has its own advantages and disadvantages.

Dr Jai Prakash, Ph.D

Principal Scientific Officer Officer-in-Charge, Pharmacovigilance Cell for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Govt. of India, Ghaziabad

Dr. Jai Prakash has done graduation and postgraduation in pharmacy from College of Pharmacy (presently known as Delhi Institute of Pharmaceutical Sciences and Research, New Delhi) and Doctorate from the Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi. He is the Principal Scientific Officer and Officer-in-Charge, Pharmacovigilance Cell for Pharmacovigilance Programme of India (PvPI), at Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Govt. of India, Ghaziabad. He has been involved in coordinating various activities of the Commission such as - revision of Indian Pharmacopoeia (IP), National Formulary

of India (NFI), PvPI, Guidance Manual for Compliance of IP, Workshops-cum-Symposia and addressing the technical queries raised by the stakeholders.



42

Prior to joining as Principal Scientific Officer, he served as Senior Scientific Officer in IPC, Senior Scientific Officer Grade I (Pharmacology) in Central Indian Pharmacopoeia Laboratory (CIPL), Lecturer under the Directorate of Training and Technical Education, Govt. of Delhi etc. He has several publications to his credit in national and international journals of repute. He is the recipient of Ms Geeta Mittal Medal for Basic Research in the field of Oncology for being the best postgraduate at AIIMS, Servicer Young Investigator's Award and Certificate of Merit in M. Pharm.

DR. V. Kalai Selvan, M. Pharm, Ph.D

Senior Scientific OfficerIndian Pharmacopoeia Commission, Government of India (Ministry of Health and Family Welfare) , Sector 23, Raj Nagar, Ghaziabad, UP

Dr. Kalai is Officer in charge from National Coordination Centre (Indian Pharmacopoeia Commission) for coordinating Pharmacovigilance Programme of India. He has Contributed to bring out I.P 2010 and 4th Edition of National Formulary of India. He is serving as a member, editorial team of PvPI Newsletter. He also has worked as a Lecturer and Assistant Professor in various Pharmacy institutions and worked as a Clinical Research Coordinator, in Kovai Medical Center and Hospital (KMCH), Department of Cardiology, Coimbatore.He has Published 21 research and review articles in various national and international journals. A provisional Indian patent has been filed for Synergistic

herbal ophthalmic composition, which delays the onset and progression of cataract. He also has authored a chapter entitled as 'Anti platelet drugs', 'Current Pharmacopoeial status of Phyllanthus species', 'Natural therapies for ocular disorders' in the book of Drug Screening Methods (Preclinical Evaluation of New Drugs), Phyllanthus species: Scientific evaluation and medicinal applications and Herbal Drugs: A modern approach to understand them better respectively. Guided 5 M.Pharm and M.Sc thesis projects.

Dr. Sushma Srivastava, Ph.D

ScientistDelhi Institute of Pharmaceutical Sciences &Research(DIPSAR)Govt. of NCT Delhi, PushpVihar, Sector-3, MB Road,New Delhi-110017, IndiaE-mail: [email protected]

Dr. Sushma graduated from University of Allahabad in 1976. She did postgraduation in 1978 and was awarded Ph.D in 1986 from Allahabad University. She joined Dr. RP Centre for Ophthalmic Sciences, AIIMS in 1986 and was trained in ocular pharmacology and was involved in research related to the screening of herbal drugs used in Indian system of medicine for their potential efficacy in treatment/prevention of various ophthalmic diseases. She is one of the inventors of the patent granted for the process of preparing herbal anti cataract formulation. She has more than 50 publications in national and international journals of repute. She has been involved in training the students

in ocular pharmacology. She has been involved in medical writing. Dr Sushma has authored number of chapters in books on various topics such as Drug Screening Methods, Pharmacovigilance, Drug Discovery etc. She attended and organized several national and international conferences.

She is member of many Societies. She is member secretary of Rational Independent Ethics Committee and member of Max Healthcare Ethics Committee, Saket, Institutional Ethics Committee, Max Super Speciality Hospital Patparganj, Moolchand Medcity Institutional Ethical



43

Review Board.

She is currently working as Scientist at Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), New Delhi.

Dr. Rajani Mathur, Ph.D

Assist. Professor, Department of PharmacologyDelhi Institute of Pharmaceutical Sciences & Research (DIPSAR)Govt. of NCT Delhi, Pushp Vihar, Sector-3, MB Road,New Delhi-110017, IndiaE-mail: [email protected]

Dr. Rajani Mathur, is Assistant Professor, Dept. of Pharmacology, DIPSAR, University of Delhi. She received her Ph.D (Pharmacology) & M.Sc. (Drug Assay) from All India Institute of Medical Sciences, New Delhi and B.Pharm, from Hamdard University, New Delhi.

She was awarded Scholarship grant By NDDO Education Foundation-2010 for Poster presentation in 8th International Symposium on Targeted Anticancer Therapies, TAT2010, Bethesda, USA. In 2006, she received a Jaipur Award for the Best Poster at the Annual Conference of the Indian Pharmacological Society. She has also received Prof. G.K.PAL AWARD for best paper by Association of Physiologists and Pharmacologists during 57th Annual

Conference at AIIMS, New Delhi.

Her research interests are on the cellular and molecular basis of cancer and metabolic syndrome. She has over 20 publication in national and International journal, and 23 chapters in various book.

Ankita Arora, M. Pharm

Manager, Medical Writing, Kinapse

Abstract

Real World Evidence & Its Importance for Regulations - Current Scenario of Clinical Trials Registrations in India

Ankita Arora

It is projected that spending on healthcare is expected to grow to 13% by 2025 in India. This projected growth would incur higher demand of healthcare products including pharmaceuticals and is positive for drug development. However, drug development in the pre-clinical and clinical phases and reporting needs to be regulated by the U.S. F.D.A., W.H.O. and other country specific guidelines. As per the Declaration of Helsinki, every clinical trial must be registered in a publicly accessible database before recruitment of the first

subject and authors have a duty to make publicly available the results of their research on human subjects.Search on clinicaltrials.gov (service of the U.S. National Institutes of Health)showed 135,651 clinical studies that have been registered by 15 November 2012. Of these, 2432 studies have trial sites in South Asia, with India being the major destination with over 85%registered studies.Since 15 June 2009, trial registration in India throughClinical Trials Registry - India (one of the primary registry of W.H.O. International Clinical Trials Registry Platform) has been made mandatory by the Drugs Controller General (India). With more stringent regulations, the current scenario of registrations in India is improving. This will ensure transparency and will ultimately strengthen the validity and value of the research being conducted in India.



44



45

P-01

Formulation and Evaluation of Taste -Masked Oral Suspension of ErythromycinTulshi Chakraborty, Vipin Saini, Pradeep Saini,

M.M.College of Pharmacy, M.M University Mullana , Ambala -133207 (Haryana)Email id: [email protected]

Abstract:

Taste is an important factor in the development of oral dosage form. The problems are bitter and obnoxious taste of drug in paediatric and geriatric formulation preparation and evaluation is a challenge to the pharmacist in the present scenario. In order to ensure patient compliance bitterness masking becomes essential. People wish to take orally administered suspension of drugs that have a nice taste, and more effective. The purpose of this research is to mask the intensely bitter taste of erythromycin using ion exchange resin and to formulate test masked-oral suspension of erythromycin. When suspension is swallowed bitter taste may not be felt because ion exchange complex does not release drug at salivary pH. When it comes in contact with environment of stomach, complex breaks down and releasing the drug. Oral taste masked suspension was prepared forming the complex of drug erythromycin with ion exchange resin i.e. Indion 204 in different ratios to get the optimum result.. This studies concluded that our prepared test-masked oral suspension of erythromycin is easy redispersibility, more than 99.2% of drug release at pH 1.5 within 20 min, and easily acceptable especially for non cooperative paediatric and geriatric patients, simplification of manufacturing procedure and is economical.

P-02

Pharmacovigilance: Its Current Status & FutureAmit

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi,Sec-3 Pushp vihar, New Delhi-110017, India

Abstract:

Pharmacovigliance is science & activities relating to the detection, assessment, understanding & prevention of adverse effect or any other drug related problem. ADR is an adverse drug reaction has been defined as any noxious, unintended & undesired effect of a drug which occurs at a dose used in humans for prophylaxis, diagnosis, therapy or modification of physiological function. In present era there is wide use of medicine, which result in the higher no drug interactions and ADR happening in present, that's why we need an effective system of ADR monitoring for the safety and prevention from the side effect. Pharmacovigilance is the branch of science which deals with the monitoring of these side effects. There are some devastated events happens due to ADR of drugs like sulfanilamide disaster, thalidomide tragedy etc. therefore its highly essential to have an proper monitoring and reporting of unexpected effects of drugs. In India 1986 ADR monitoring system consisting of 12 regional centers are purposed to open. In 1989 under drug controller of India 6 regional centers are open. Out of which only two are in working status currently.( Mumbai & Delhi ) India joined WHO program for international ADR monitoring center in Sweden.( Uppsala monitoring center ).Indian center which communicate with the Uppsala is in New Delhi AIIMS pharmacology department. Currently Pharmacovigilance is handled by the national Pharmacovigilance program (PVP) & central drugs standard control organization (CDSCO). They entitled AIIMS as the recording center for the less frequent ADR as well normally occurring ADR. In India large no of population of population is exposed to the drugs hence large data is obtained & recorded. This is then communicated to UPPSALA monitoring center in Sweden. Pharmacovigilance program for India (PVPI) Central drug standard control organization (CDSCO) under the aegis of ministry of health & family welfare govt of India in collaboration with department of pharmacology(AIIMS).Aim of Pharmacovigilance in India .2009-10 initiation phase, 2010-11 expansion & consolidation , 2011-



46

12 expansion & maintenance phase, 2012-13 expansion & optimization, 2013 -14 excellence. In 2011 PVPI recorded over 8,388 individual cases submitted by ADR monitoring centers out which maximum no of ADR are of drug phenytoin.

P-03

Determination of Clinical Outcome And Pharmacoeconomics of Anti-Rheumatoid Arthritis Therapy Using Cdai, Eq-5d-3l and Eq-Vas As Indices of Disease Amelioration

Kandhare AD, Ghosh P, Visnagri A, Shiva Kumar V, Rajmane AR, Adil M, Bodhankar SLDepartment of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune,

Maharashtra, 411038. India

Abstract:

Introduction: Arthritis is a severe debilitating chronic disease. The objective of the present investigation was to evaluate the clinical outcome and cost effectiveness of anti-rheumatoid arthritis regimen for the treatment of arthritis.

Material and Methods: The patients were classified into three treatment cohorts on the basis of the treatment regimens prescribed by the physicians. These were group I consisting of patients treated with monotherapy of non-steroidal anti- inflammatory drugs alone, group II consisting of patients treated with disease modifying anti rheumatoid drugs + non-steroidal anti- inflammatory drugs and group III consisting of patients treated with disease modifying anti rheumatoid drugs along with oral Corticosteroids. The patient reported outcome was measured using European questionnaire 5 dimension 3 levels (EQ-5D-3L) and European questionnaire visual analogue scale (EQ-VAS) before and after the treatment regimen. Clinical outcome was measured using Clinical disease activity index (CDAI). The details of costs were recorded by interviewing the patients.

Results: The patient reported outcome measured by EQ-5D-3L and EQ-VAS was significantly improved in patients belonging to group III when compared to group II (P < 0.05) and I (P < 0.001) respectively. The outcomes of CDAI scores demonstrate that the mean change in CDAI levels was 7.04, 12.01 and 16.98 in group I, II and III respectively. Total cost incurred per patient was found to be equal to Rs. 1120 ($19.6) in group I, Rs. 1685 ($29.49) in group II and Rs. 2465 ($43.14) in group III. The ACER was determined as 159.09 in group I, 140.299 in group II and 145.17 in group III.Conclusion: Amelioration of arthritis in clinics can be effectively measured by validated instruments (EQ-5D-3L, EQ-VAS, CDAI) and DMARDs along with NSAIDs are the most cost effective therapy for treatment of arthritis.

P-04

Economic Burden of Type-2 Diabetes Mellitus in a Residential University In Northern India

Pareek R.P., Singh A., Siddhartha V., Pandey M.M.Department of Pharmacy, Birla Institute of Technology & Science, Pilani

Abstract:

Introduction: Type-2 Diabetes mellitus is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. The study involves the concept of Pharmacoeconomics which refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. The study will estimates the cost of various oral hypoglycemic agents (OHA) involved in the management of type-2 Diabetes mellitus and to reduce the economic burden on society.

Materials &Methods: The study is done in the residential university of northern region of India. The data is collected from the medical store of the residential university. The study involves the retrospective analysis of the drug which is involved in the treatment of type-2 Diabetes mellitus. The



47

data is collected for one calendar year where the comparative prescription of various OHA has been taken into account. The cost estimation is done on the basis of the amount of different drugs sold in the given sample population.

Results: We calculated the overall cost that is incurred to patient with the specific disease, expenditure on different drugs and also expenditure on different brands currently marketed. The study indicated that there is significant difference of costs incurred for the patients relying on respective marketed brands.

Summary: The results obtained instigates for further research to be carried in this area to determine the cost-effectiveness analysis and cost-benefit analysis of diverse brands. The study indicates that economic burden on society related to type-2 Diabetes mellitus can be reduced fruitfully. These differences highlight some of the challenges in future aspects of Pharmacoeconomic study.

P-05

Pattern of Use and Pharmacoeconomic Impact of Antihypertensive Drugs in Hypertensive Disorders In Pregnancy

1 1 1 1 2 1Yadav B , Panda B K , Sajith M , Pawar AP , Nimbargi V , Mirghe S1Department of Clinical Pharmacy, Poona College of Pharmacy, BVDU, Pune, Maharashtra.

2 Department of Obstetrics & Gynaecology, Bharati Medical College and Hospital, BDDU, Pune, Maharashtra.

Abstract:

Introduction: Hypertensive disorders of pregnancy (HDP) are important cause of maternal and fetal morbidity and mortality. It is believed that 10-15% of maternal mortality in developing countries is due to HDP. Antihypertensive agents are recommended and are widely used to treat HDP, though the drugs recommended are very few and safe in nature.

Materials & Methods: The prospective study was conducted and analyzed for pharmacoeconomics impact of antihypertensive drugs in pregnant inpatients admitted to the department of Obstetrics and Gynaecology of Bharati Medical College and Hospital, Pune, Maharashtra.

Results: Out of 665 inpatients, 62 individuals (9.3%) were diagnosed with various hypertensive disorders of pregnancy. Nearly 22.5%% patients diagnosed with pregnancy induced hypertension, 72 % pre-eclampsia (29.0 % were with mild preeclampsia, 43.5% with severe preeclampsia) and 4.8% with eclampsia. The mean duration of treatment of hypertension was same for PIH and preeclampsia (4.3 days; range 1d -10d). Calcium channel blockers (Nifedipine, 80.6%), Methyldopa (75.8%) and Beta blockers (Atenolol, 30.6%), were the most popular drugs. The utilization of diuretics was less (11.2%). Combination therapy was used more commonly than monotherapy (74.9% vs. 25.8%). The mean cost of combination therapy during the stay for pregnancy induced hypertension, eclampsia, mild preeclampsia, and severe preeclampsia was US $0.9, US $5.4, US $0.9 and US $2.5 respectively. The cost of prescription was higher in those inpatients administered with iv and oral Labetelol with MAP of 140 mmHg. The cost incurred was higher if treated for longer duration.

Summary: The cost of treatment of hypertension was moderately high in patients treated with labetolol and in hypertensive disorders in pregnancy like severe preeclampsia and eclampsia.

P-06

Present Status & Future Challenges of Clinical Trials in IndiaDeepti Rajaur

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi,



48

Sec-3 Pushp vihar, New Delhi-110017, India

Abstract:

Clinical Trials may be defined as "A Systematic study of new drugs, treatments, therapies, surgical procedures and new medical devices on human volunteers with the aim of determining the safety and efficacy of new drug before making it publically available." India is becoming one of the preferred destinations for conducting the clinical trials due to its huge population, human resources and economic environment. During 2011-12, Indian clinical trial market is estimated to be $480 million, a growth of about 20% over 2010. Currently 513 clinical trials are being conducted in India. Oncology, Central Nervous system and infectious diseases are the most popular therapeutic areas, followed by diabetes and cardio-vascular diseases. In 2011, about 2/3rd of trials are phase-3, 20% are phase-2, lot of phase-1 trials are outsourced. Moreover, the market is getting boost from improved IPR protection and also from reduced taxes and duties on CROs engaged with clinical trials. Unethical practices, falsified data, frauding trial subjects, noncompliance of GCP guidelines and conduction of trials without DCGI approval are some discrepancies going on converting boon to bane. There are several reports on exploitation and fatalities of trial participant alarming the need of strict vigilance. In India, it is easy to conduct clinical trial than in North America or Europe due to strict legislation. In India, trial participants are exploited because of illiteracy, poverty, unawareness of their rights. These all discrepancies may produce the future challenges which may prevent the smooth conducting of clinical trials in India. These challenges include need of trained educated work power, efficient clinical data management, following of SOPs and Ethics Committee regulations, obtaining proper informed consent, compliance with protocol, maintenance of confidentiality. This review aims to provide comprehensive information about present scenario and challenges in clinical trials.

P-07

Drug Discovery in Clinical Research Focusing on Discovery of Newer Proton Pump Inhibitors

Nidhi Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi,

Sec-3 Pushp vihar, New Delhi-110017, India

Abstract:

Drug Discovery is the process by which new drugs are created and developed unlike basic Research, which seeks to better understand the underlying cause of diseases. The drug discovery process involves several distinct steps such as Target Identification, Target validation, Lead screening and Lead optimisation. By summarising these steps we focus on the Discovery and Development of Proton Pump Inhibitors .In the year 1975 Timoprazole was found to inhibit acid secretion but with toxic effects. A derivative of Timoprazole, Omeprazole was discovered in 1979 and was the first of a new class of drug that control acid secretion in the stomach, a proton pump inhibitor (PPI). In 1980 an Investigational New Drug (IND) application was filled and Omiprazole was taken into phase III human trails in 1982. A new approach for the treatment of acid related disease was introduced. Omiprazole was quickly shown to be clinically superior to many other Drugs. Losec became the worlds biggest ever selling Pharmaceutical and by 2004 over 800 million patients had been treated with the Drug worldwide. During 1980s about 40 other companies entered the PPI area but few achieved market success Takela with lansoprazole, Byk gulwith pentoprazole and Eaisic with rabeprazole, all of which were analogue of Omeprazole. Despite the fact that PPI have revolution the treatment of GERD there is still room of Drug for Development better efficacy and fulfil the unmet medical desires. Therefore a new class of PPI, Potassium competitive acid blockers and acid pump antagonist, have been under development and will most likely be the next generation of drug that suppress gastric activity. We also focus on the recent



49

technologies used in the Drug Discovery stages such as Combinatorial chemistry (the technique which have been used for the synthesis of defined compound having screened for pharmacological activity) in the lead identification process, High Throughput Screening (a modern technique allowing the rapid screening of large compound collection against a variety of pulative drug targets) in the Lead optimisation process.

P-08

Current Scenario of Vaccines in Indian MarketNidhi Choudhary and S K Gupta*

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi,Sec-3 Pushp vihar, New Delhi-110017, India

Abstract:

With growing population, scare of new pandemics and highly prevailing infectious and non infectious diseases ,India has emerged as a key vaccine manufacturer . India is the major supplier of Vaccines to UNICEF which in turn supplies 40% of the total vaccine demand for childhood vaccination in more than 100 countries. In the recent developments, during the outbreak of H1N1 (swine flu), within a year' Zydus Cadilla, the Ahmedabad-based drug company was first to launch the H1N1 vaccine in 2010-11. The current Indian vaccine market is estimated to be about $900 million, with a potential to touch $4.6 billion by 2017. Major key vaccine manufacturers in India are The Haffkine Institute, Biological E., Serum Institute of India, Santha Biotechnics Ltd., Bharat Biotech and Panacea Biotech. The key drivers for the vaccine market are low cost of clinical trials, relatively low cost of manufacturing and huge demand in local market.

Vaccine development is tightly regulated by a hierarchy of regulatory bodies. Guidelines provided by the Indian Council of Medical Research (ICMR) set the rules of conduct for clinical trials from Phase I to IV studies as well as studies on combination vaccines. These guidelines address ethical issues that arise during a vaccine study. A network of Adverse Drug Reaction (ADR) monitoring centers along with the Adverse Events Following Immunization (AEFI) monitoring program provide the machinery for vaccine pharmacovigilance.

As a therapeutic class, vaccines are extremely cost-effective agents. In addition, they are one of the few public health for agents in this class, researchers must consider costs interventions that may directly lower medical costs. In conducting pharmacoeconomic analyses incurred at both the health system and societal levels, as well as cost savings realized through the prevention of disease.

P-09

Pharmacoeconomics: Analysis Tool for Health CarePratyush Lohani*, Pratibha Nand, Neelam Vashist

Maharaja Surajmal Institute of Pharmacy, Guru Gobind Singh Indraprastha University,New Delhi

Abstract:

The top two health care concerns of the public today are rising costs and a lack of access to adequate health care. In fact, health care costs can even qualify as the chief economic worry for the governments across the globe. With the rising health care cost and the quality of health coverage declining, pharmacoeconomics and outcomes research can provide the necessary tools to bring about the much needed fundamental changes in the health care system across the globe. Pharmacoeconomics is a branch of health economics that deals with the description and analysis of the costs of drug therapy to the health care system and society. Pharmacoeconomics research identifies, measures, and compares the cost and consequences of pharmaceutical products and services. Pharmacoeconomics analysis uses tools for examining the impact of alternative drug therapies and other medical interventions. It can provide answers to important questions like the



50

drug of choice for the particular disease,best drug for the pharmaceutical manufacturer to develop, the drugs to be included in the hospital formulary, the quality of patient life being improved by a drug therapy and the patients outcome for various treatment modalities. Pharmacoeconomics is still an evolving field and the challenges in this field are also enormous. The biggest challenge is the use of correct methodologies and perspectives for the evaluations of the costs and consequences of drug therapy. However, the correct use of this field having a mix of art and science by the healthcare professionals can help in providing efficient and adequate health care services to the very poor.

P-10

The Role of Education Imparted to Enhance Patent Awareness in IndiaIndu Shrivastava, K.K. Sharma, Dilip Saxena, Pranav Pandey

Department of Clinical Research, School of Allied Health Sciences,Sharda University, Greater Noida-201 306

Abstract:

The country is falling short of trained professionals in Patents. The government agencies, educational institutions and the industries in India are striving to train individuals to produce skilled professionals with the required practical understanding of Intellectual Property rights (IPR) in relation to the development of the existing systems in the area of IP.

In the paper, an effort will be made to briefly discuss the history of patents in India. The focus of the paper is to discuss and portray a comprehensive and comparative report of the institutions in India currently imparting the relevant education to become an adept in the field of Patents. The scope of a career in Patents and the Salary of trained individuals with a degree/Diploma in Patenting in India will also be discussed. Based on this scenario, measures could be taken to boost the educational awareness for individuals who are seeking exciting opportunities within the pharmaceutical industry and research institutions. It will also serve to fill the gap of trained Patent Professionals in the country to further strengthen the economy and research relevant to pharmaceutical growth and drug development to stay ahead in the international markets.

Keywords: IPR; Patents; Scope and role of education and academia in patents, patent professionals.

P-11

Quality of Life of the Breast Cancer SurvivorsParameshwar Pillai

Dept. of Pharmacology, Jaipur College of Pharmacy, Jaipur

Abstract:

Introduction: There are only small amount of information available about the Quality of life of breast cancer survivors in India, but due to continuously developing treatment regimens and different treatment approach, number of breast cancer survivors are increasing, in such situations this seems to be necessary to evaluate the impact of cancer on the Quality of life of these groupsMethod: we have identified 70 women patients in the test group who have survived 5 or more than five years after the breast cancer treatments (i.e. those patients treated for breast cancer during 2005-2007) similarly in control group 70 healthy women who never had any cancer but with the same age, educational and other attainments. We have applied the EQ-D-5L questionnaire to both of these cohorts. We are doing this research at Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan. Ethical clearing has been obtained.



51

P-12

Health Technology Assessment: Need of the HourSachin Kumar

Delhi Institute of Pharmaceutical Sciences & Research, Sec III, Pushp Vihar, New Delhi-110017

Abstract:

Technological innovation has yielded in the improvement in health care delivery and patient outcome. But, healthcare technology proliferation most of the time results in increase of health care cost. While in developed countries, cost is not a deterrent in utilization of a state of art technology for healthcare but in developing countries price is of great concern. Culprit or not, technology can be managed in ways that improve patient access and health outcomes, while continuing to encourage innovation.

Health Technology Assessment (HTA) considered the effectiveness, appropriateness and cost of technologies by finding the answer of four questions, does this technology work, for whom, at what cost and how does it compare with alternatives. HTA addresses the direct and intended consequences along with indirect and unintended consequences of a technology to the policy makers.

India is growing so does its market. Various health care providers and insurers are either already entered or preparing to enter the market. Therefore, it is the need of the hour that India should incorporate HTA in its health related policies. HTA contributes in many ways to the knowledge base for improving the quality of health care, especially to support development and updating of a wide spectrum of standards, guidelines, and other health care policies.

P-13

Ceiling Price for Essential DrugsShewade DG, Stanley A,

Department of Pharmacology, JIPMER, Puducherry 605006.

Abstract:

National Pharmaceutical Pricing Authority (NPPA) is having control over fixing the price for 76 bulk drugs and formulations according to the Drug (Price control) order,1995. As per the order, the fixation of price is cost-based. In cost based system the retail price of the drug is calculated by the formula,R.P= (M.C + C.C + P.M + P.C) x (1 + MAPE/100) + E.D; where R.P - Retail Price, M.C - Manufacturing Cost, C.C - Conversion Cost, P.M - Packing Material, P.C - Packing Charges, MAPE - Maximum Allowable Post-manufacturing Expenses (%) and E.D - Exercise Duty. MAPE should not exceed 100 percent for indigenously manufactured scheduled formulations. So the market price should not exceed more than two times the cost of production.

P-14

Estimation of the Long Term Cardiovascular Events Using UKPDS Risk Engine in a Representative Western Indian Population Suffering From Metabolic Syndrome

Shiva Kumar V, Ghosh P, Visnagri A, Kandhare AD, Rajmane AR, Adil M, Bodhankar SLDepartment of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune,

Maharashtra, 411038. India

Abstract:

Introduction: Long term cardiovascular complications in metabolic syndrome is a major cause of mortality and morbidity in India and forecasted estimates in this domain of research are scarcely reported in literature.



52

Objective: To estimate the cardiovascular events associated with a representative Indian population of patients suffering from metabolic syndrome using UKPDS risk engine.

Material and Methods: Patient level data was collated from 567 patients suffering from metabolic syndrome through structured interviews and physician records regarding the input variables which were entered into the UKPDS risk engine. The patients of metabolic syndrome were selected according to guidelines of National Cholesterol Education Program-Adult Treatment Panel III (NCEP ATP III), modified NCEP ATP III and International Diabetes Federation (IDF) criteria. A projection for 10 simulated years was run on the engine and output determined. The data for each patient was processed using the UKPDS risk engine to calculate an estimate of the forecasted value for the cardiovascular complications after a period of 10 years.

Results: The absolute risk (95% CI) for CHD, fatal CHD, stroke and fatal stroke for 10 years for CHD, fatal CHD, stroke and fatal stroke was 3.79(1.5-3.2), 9.6(6.8-10.7), 7.91(6.5-9.9) and 3.57 (2.3-4.5)respectively. The relative risk (95% CI) for CHD, fatal CHD, stroke and fatal stroke was 17.8(12.98-19.99), 7(6.7-7.2), 5.9(4.0-6.6) and 4.7(3.2-5.7) respectively.

Conclusions: Simulated projections of metabolic syndrome patients predict serious life threatening cardiovascular consequences in the representative cohort of metabolic syndrome patients in western India.

P-15

Risk Management in PharmacovigilanceShubhika Kwatra*, Aastha Ahuja, Archana

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi, New Delhi. *Email: [email protected]

Abstract:

This paper discusses Risk assessment of medicines and its role in Pharmacovigilance. Pharmacovigilance is defined as the 'science and technology relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems'. Risk management system (RMS) is a set of pharmacovigilance activities designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those activities.All the safety information on new drugs from development to post-approval stages is collected, compiled, evaluated and managed to give guidance to companies on effective post-marketing surveillance. Therisks of the drug are summarised; benefit of the medicine is weighed against its risks;and the risks are communicated to the health professionals and the publicto ensure safety of the drug. The Risk Management Plan (RMP) consists of seven parts: Product(s) Overview, Safety Specification, Pharmacovigilance Plan, Plans for post-authorisation efficacy studies, Risk minimisation measures, Summary of the RMP and Annexes.Risk ManagementinvolvesconductingPharmacovigilance training and awareness programs; detecting and reporting Adverse Drug Reactions (ADR); proper supervision of functioning of the ADR Monitoring Centres; and adopting Risk minimisation measures.It ensures safety management of drug, prevents withdrawal of new drugs at early stages and protects the patients especially at early stage of marketing.Risk management basically puts forward the framework for the Pharmacovigilance Plan and is its essential component.

KEYWORDS: Pharmacovigilance, Risk Management, Safety, Adverse Drug Reactions.



53

P-16

Cost Estimation of Asthma Management in a Residential University in Northern IndiaPareek R.P., Siddhartha V., Singh A., Pandey M. M.

Department of Pharmacy, Birla Institute of Technology & Science, Pilani

Abstract:

Introduction: Pharmacoeconomics is the description and analysis of costs of drug therapy to healthcare systems & society. Asthma is a chronic inflammatory disorder of the airways, with varying prevalence in different countries ranging from 7% to 20%. Hence, the morbidity and mortality associated with asthma are a ponderous burden to developing countries like India. In this article, we will present the direct medical costs of various brands that are associated with the disease treatment for one calendar year in a residential university.

Materials & Methods: Data of one calendar year was obtained from medical store of the residential university in northern India. We calculated the expenditure for purchasing the medicines of diverse categories and brands for asthma management and also evaluated the total amount charged for all the prescriptions using retrospective analysis for that year.

Results: The direct economic burden of asthma to people in a residential university was calculated from the data obtained from medical centre. We calculated the percentage expenditure for asthma treatment among entire cost of prescriptions that year. The obtained results showed that asthma imposed a significant economic burden.

Summary: Our findings may be of interest to physicians and others interested in outcomes and cost of prescriptions. The percentage of the expenditure spent on asthma relative to total prescription gives a glimpse of economic burden of asthma relative to other prevalent non-communicable diseases in the university. Since the university is comprised of diverse people, we can extrapolate the obtained results to entire population living in similar weather as asthma majorly depends on environmental factors.

P-17

Evergreening - A Controversial Issue in Pharma IndustrySurbhi Rohatgi,

Delhi Institute of Pharmaceutical Sciences & Research, New Delhi-110017

Abstract:

A patent is a set of exclusive market monopoly granted by the national government (state) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention for the benefit of mankind. Though patents are effective tools for promoting innovation and protecting intellectual property in the pharmaceutical sciences, there has been growing concern that patents can have a negative effect on patient care and the practice of medicine. Evergreening or Line Extension involves "patent life cycle enhancement techniques" employed by the pharmaceutical organizations to take advantages of the loopholes in regulatory systems to extend the market monopoly by obtaining multiple patents that cover different aspects of the same product. This provides the innovator companies sufficient time to recover their estimated R&D costs. A fine balance is needed between investment in research and accessibility of protected inventions to the public. Evergreening is a manipulation of the patent system that impedes the introduction of generic medications, limits options available to patients, increase the cost of health care delivery, and make cooperative research more difficult.



54

P-18

Need For Pharmacovigilance of Ayurvedic MedicinesVasudha,

Delhi Institute of Pharmaceutical Sciences and Research, New Delhi-110017

Abstract:

The use of Ayurvedic medicines is growing rapidly among the people. Associated with this use are growing concerns about the safety of these medicines. There is a strong belief that these medicines are devoid of adverse effects and thus, detection of these adverse effects is a big challenge. There is a large number of spurious drugs, manufacturing conditions are not controlled, lack of quality assurance, signal detection is difficult, multi-ingredient formulations are made- all leading to inaccurate identification of adverse events of Ayurvedic medicines. To prevent this, there is a need to introduce the pharmacovigilance concept in herbal curriculum, making reporting of adverse reactions to regulatory authorities mandatory, training of Ayurvedic experts in pharmacovigilance and encouraging better communication between patients and health professionals. Thus it is the need of hour to have pharmacovigilance of Ayurvedic medicines in order to prevent the adverse reactions and have a safer and wiser use of these medicines.

P-19

Pharmacoeconomics and Its Role in Clinical ResearchVishal Yadav, S. K. Gupta

Delhi Institute of Pharmaceutical Sciences and Research,Sector 3, Pushp Vihar, New Delhi 110017

Abstract:

Increasing health care cost is a major concern in the developing world and has increased the individual economical burden for a common man. In India majority of healthcare spending is done by patients out of their own pockets, unlike medical insurance policies in most developed countries. Therefore, the concepts of pharmacoeconomics are essential for physicians to prescribe individualized drug therapy based on essential drug concept. Since development of new drugs is long, costly and risky, and decisions must be made how to allocate considerable research and development (R&D) resources. Pharmacoeconomics also has an essential role in informing internal decision-making (within a company) during drug development. The use of pharmacoeconomics in early development phases is likely to enhance the efficiency of R&D resource use and also provides a solid foundation for communicating product value to external decision-makers further downstream, increasing the likelihood of regulatory approval and commercial success. The poster provides an introduction of pharmacoeconomics, its various methods of evaluations such as cost minimization analysis (CMA), cost benefit analysis (CBA), cost utility analysis (CUA), cost effectiveness analysis (CEA) and guidelines to delivering quality care cost effectively. Pharmacoeconomic researches should be introduced strongly in India and should be performed from the clinical trial onwards so that the government can ensure that money spends in the right direction and also reduce the financial burden on patients.

P-20

Validation: An Essential Quality Assurance Tool in PharmaceuticalsAnoosha, Sarika Madan*, B. P. Srinivasan

Delhi Institute of Pharmaceutical Sciences and Research, Formerly College of Pharmacy(University of Delhi), Pushp Vihar, Sec-III, New Delhi-110017, India

Email: [email protected]

Abstract:

Validation involves a series of activities taking place over the lifecycle of the product and process development. A validated process is one which has been demonstrated to provide a high degree of



55

assurance that uniform results will be obtained to meet the required specifications and has therefore been formally approved.

Validation as per US FDA guidelines is defined as "Establishing documented evidence, which provides a high degree of assurance that a specific process (such as manufacture of pharmaceutical dosage forms/APIs) will consistently produce a product meeting with its pre-determined specifications and quality characteristics." Validation is an integral part of quality assurance involving systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as desired. Process validation is mandatory as per the Current Good Manufacturing Practices (cGMP) regulations for finished pharmaceuticals and components, 21 CFR parts 210 and 211.

There are several significant reasons for validating a product and/or a process. First, manufacturers are abided by law to conform to the "predicate rules" of cGMP regulations. Second, good business dictates that manufacturers avoid the possibility of rejected or recalled batches. Third, validation helps to ensure product uniformity, reproducibility and quality. Thus, validation is to optimize pharmaceutical productions and supporting processes including raw materials, cleaning process, analytical methods, finished products and packaging materials with an option of prospective, retrospective, concurrent and revalidation.

P-21

To Find Upper Limit of Reference Value of QT Interval in Healthy Young Indian Men Using Bootstrap Method

Akhil Gupta, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)(University of Delhi), Pushp Vihar, Sec-III, New Delhi-110017, India

Abstract:

A retrospective study was done based on ECG data of 900 healthy young Indian men from August 2009 to May 2010. Relationship between QT (dependent) and RR (independent) intervals was assessed using linear and exponential regression equations. RR set was broken down into 9 equal subsets. Sampling with replacement (using bootstrap technique) was done for QT intervals falling in each RR subset to increase the reliability of the results. The procedure was repeated 1000 times. Point estimates of QT [Mean ± 1.96 (Standard deviation)] were derived for each RR subset. Linear and exponential regression equations were obtained between point estimates of QT and central values of each RR subset. As lower error was found to be associated with linear equation, it was used to derive upper limit of QT interval as 421.44 millisecond, for RR = 1 second. The outcome of the study was that upper limit of QT interval for healthy young Indian men was found to be lower as compared to that suggested in literature.

P-22

Reporting of Adverse Drug Reactions in India: Current ScenarioAastha Ahuja, Shubhika Kwatra, Archana Arora

Email id : [email protected] Institute of Pharmaceutical Science and Research, New Delhi

Abstract:

Despite stringent and comprehensive phases of clinical trials and surveillance efforts ,unexpected and serious ADRs repeatedly occur after the drug is marketed. Adverse drug reactions enhance suffering of patients and increase morbidity and mortality. Reporting of these ADRs is of paramount importance in the success of a pharmacovigilance programme of a country. Ideally, all reactions, but

S. K. Gupta, Deepak Chilkoti



56

certainly serious, severe, unusual and unexpected reactions particularly with new drugs must be reported.

While major advancements in the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India. India has the second largest population in the world ,however it rates below 1% in terms of ADR reporting against the world rate of 5%. The National Pharmacovigilance program of India rolled out in November 2004 with support from the World Bank has established several centres around the country, where these ADRs can be reported. Unfortunately, inspite of the presence of five well organised centres for drug monitoring in the country, the number of reports sent annually are dismal. This calls for the urgent need to reinforce the monitoring of adverse reactions to drugs.

This article gives a systematic review of the pharmacovigilance in India and also discusses the various strategies and proposals to build, maintain and implement an appropriate system for reporting of adverse drug reactions.

KEY WORDS: Adverse drug reactions (ADRs), ADR reporting, pharmacovigilance

P-23

An Overview of Generic Vs Branded DrugsMeenakshi Vats, Prof B.P.Srinivasan and S.K.Gupta*

Department of Pharmaceutical Management, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi,

Push Vihar, Sec-3, New Delhi-110017, India

Abstract:

The pharmaceutical industry of India has matured over the years into a major producer of bulk drugs, rated among the top five in the world. This 'generic capability' of India has attracted worldwide attention. The generic pharmaceuticals sector in India have come of age, their future sustainable growth depends on ensuring competitive markets. The Indian generic drug market is surrounded by some key developments that offer huge opportunities as well as threats. Increasing influence of foreign multinationals has become a cause of concern for authorities and market players. At the same time, patent expiries may turn out to be a growth booster. Rising complexity due to more generic "mature" products is placing new stress on the supply chain. Pricing pressure from generic companies, gaining share in cost-conscious developed markets and financially strapped developing economies, continue to intensify. Together, these industry dynamics add to the urgency of developing new marketing strategies for branded companies. Difference in price-to-patient index is high enough for generic drugs as compared to their branded versions with same quality. Generic companies have responded to challenges through vigorous Merger & Acquisition activity and partnership, driven by need for backward integration into active pharmaceutical ingredients, rapid geographic expansion into smaller and emerging markets and aggressive portfolio build-outs in niche, specialty, and biologic products. For e.g. Ranbaxy was acquired by Daiichi Sankyo, a Japanese innovator drug company. Daiichi Sankyo's reasons for the acquisition included not only ownership of the eventual revenue driver of generic ,Atorvastatin in the United States, but also gaining Ranbaxy's access to the rapidly growing Indian pharmaceutical market as well as its low-cost manufacturing and research capabilities. In India, generic substitution is legally not allowed so patients' awareness about generics is limited and doctors and patients do not want pharmacist to change the trade name written by doctor. Hence, consumer awareness for the generics is important and generic capabilities of Indian pharmaceutical market should be explored to the most.



57



P-24

Test of Indian Patent Rules:Threat to western Drug-maker & potential for Indian EconomyDr. SK Gupta,

Delhi Institute of Pharmaceutical Sciences and Research(University of Delhi), Pushp Vihar, Sec-III, New Delhi-110017, India

AbstractthIndia drug patent is only seven years old. India ranks 68 on the Intellectual property Protection out

thof 142 countries with a value of 3.5 on 1-7 point scale whereas that of United States is at 28 position with a value of 5 (Dutta S and Osrio B, 2012). Although the low value of IPR in India is due to lack of Infrastructure and brain drain, the rank of India on IPR protection can be advocated on the fact that recent rulings by the Supreme Court and IPAB (Intellectual Property Appellate Board) against several multinational drug makers like Novartis (Glivec), Bayer (Nexaver), Roche (Tarceva, Pegasys), Merck (Pegintron), BMS, Eli Lilly, Gilead (Viread) etc. has raised concern in the international arena for India not being compliant to the TRIPS obligations of WTO. These decisions are based on the interpretation and appreciation of Section 3D (Doesn't considers an incremental innovations of the existing molecule or substance novel unless there is substantial/unanticipated increase in efficacy) and Section 84 (inventions are worked in India on a commercial scale and to the fullest extent without any undue delay) of Indian Patent Act 1970, Amended 2005. The legitimacy of these rules and its exercise can be explained by the DOHA Declaration 2001 and TRIPS flexibilities.

India is the supplier of generic products to nearly 200 countries and contributes to 90% of its total market. Indian drugs cost seven to ten percentage of US or Europe price to decreasing the cost to 98% (Mahapatra R, 2004). Indian GDP will to remain between 4% to 6% well above most emerging countries. With rising incomes and rates of chronic disease, India may push drug sales from $12 billion in 2010 to $74 billion in 2020 (The Economist, 2012). This has hungrily eyed the foreign drug makers. The exercise of these rulings can have detrimental effect on the manufacturer economy unless suitable steps are taken by multinational in the view of judiciary and the government stand on IPR enforcement looking into the socioeconomic condition of about 60% of its citizens. As far as least developed countries (LDC's) are concerned, they will only be obliged to enforce IPR Protection from 2016 onwards which will keep Indian economy green as supplier to these countries are Indian manufacturers.

Taking all these into consideration, many acquisitions can be seen in Indian sub-continent to enter into Indian generic market and its market penetration. These can be realized from acquisition and mergers of Piramal Healthcare by Abott, Ranbaxy by Daiichi Sankyo, Japan, Matrix by Mylan, USA etc. Not only this, leading generics players have started their manufacturing units in India like Teva Pharmaceuticals (API unit at Indore) etc. Moreover, other generic company like Cipla, Cadila etc have grown exponentially in the last decade. Nacto Pharma has taken advantage of litigating various IPR matters and have opened the market for generics either by filling ANDA (Abbreviated New Drug Application) or by being granted Compulsory Licence. The performance of companies in terms of revenue is steeper for those with dense ANDA filings than with no or few ANDA filings; Indian pharmaceutical Industry having greater density in ANDA applications (Lupin, Sun Pharma, Dr. Reddy, Ranbaxy etc.) (ICRA March, 2012).

In the light of all these India is moving towards healthy patent regime by not allowing the frivolous and malicious protection/monopoly and thereby being obliged to IPR protection only to real Novel Innovations, protecting the interest of non-insured Indian Citizens. Therefore, in order to take advantage of inevitable growing Indian Pharma Economy, ignorance to these facts is either linear or fatal.

Keywords: Intellectual Property Rghts (IPR), ANDA, Economy, WTO, DOHA, GDP, Mergers & Acquisitions

RK Gupta, S. Dongare

58

P-25

Retrospective study to determine the prevalence, clinical and pathological features of triple-negative (estrogen receptor, progesterone receptor, and human epidermal growth factor-2 receptor negative) breast cancer (TNBC) and its relationship to obesity in Indian

womenPrem Lata, Dr. SK Gupta

Delhi Institute of Pharmaceutical Sciences and Research(University of Delhi), Pushp Vihar, Sec-III, New Delhi-110017, India

Abstract:

Methods: Study involved 310 patients with invasive breast cancer who were admitted to surgical oncology department from May 2009 to April 2011. Hospital medical and pathology records provided the age at diagnosis, tumor histologic type, tumor size, grade, nodal status, and receptor status. Study population was divided into triple-negative (TN) and non- triple-negative (NTN) group. Body mass index was calculated and a value of =25 kg/m2 was considered indicative of obesity.

Results: TN tumors occurred in 62 (20%) of the 308 patients, most often in association with invasive ductal carcinomas. There were 32.51% patients with NTN tumors who were diagnosed at age <50 years compared with only 25.81% of TN patients. The mean age of patients was 55.38; the mean age of TN tumor patients at diagnosis was 56.2 ± 0.19 and of NTN patients was 55.2 ± 0.05. Lymph node-positive patients had larger tumors size (3.36 ± 0.15 vs 2.98 ± 0.14 cm) than those without lymph node involvement. TN tumors (77.04%) were more common in those patients who were classified as obese. Obesity was associated with T2 tumors, 28.77 ± 0.03 but not T3 tumors.Conclusions: Breast cancers occurred in younger women, with later stage at diagnosis, and in association with obesity and infiltrating ductal carcinoma being the commonest histologic type.

P-26

Epidemiology, Patient Burden And Related Costs Of Obesity In India1 2 2 3 4 1 1 1 1Wojciechowski P , Metz L , Mapari J , Jain M , Neoh K , Caban A , Gaweska M , Gomulka A , Plisko R , Wladysiuk

1 1M , Rys P1 2 3HTA Consulting, Krakow, Poland, Johnson & Johnson Medical Asia-Pacific, Singapore, Singapore, Johnson &

4Johnson Medical, New Delhi, India, Johnson & Johnson Medical Asia-Pacific, Petaling Jaya, Malaysia

Abstract

Objectives: Recent changes in lifestyle has triggered an increased prevalence of obesity even in developing countries such as India. Obesity is known to be correlated with increased risk of Type 2 Diabetes and Cardiovascular diseases. The burden of obesity may be underestimated as Indians are at higher risk of comorbidities with comparatively lower BMI. The aim of our research was to assess the epidemiology and burden of obesity in India.

Methods: International and Indian medical databases (MEDLINE, EMBASE, dmri.in) as well as Indian medical journals (nmji.in, japi.in) were searched to collect information regarding epidemiology and burden of obesity.

Results: The prevalence of obesity (BMI=25kg/m2) among Indian adults was setting-dependent. In rural areas, obesity was diagnosed in 5.6% - 8.5% and 5.9% - 12.7% of men and women, respectively. In urbanized regions 15.9% - 38.2% of men and 23.5% - 42.4% of women were obese. Evidence for burden of obesity was sparse and based on single trial reporting a significant correlation between increasing prevalence of obesity and growing burden of hypertension (p=0.008 and p=0,001 in men and women respectively),metabolic syndrome (p=0,005 in men) and diabetes. Obesity and diabetes place a significant economic burden on society mainly due to indirect costs including productivity loss, decreased household earnings and higher dependence



59

on welfare. According to WHO, the losses of India's national income from heart disease, stroke and diabetes reached $9 billion in 2005 and it was projected that between 2005 and 2015, India will lose $237 billion due to these conditions, which account for 1.5% of GDP.

Conclusions: Obesity and diabetes burden the constrained healthcare system of India and the entire society, leading to lost productivity and decreased household incomes. With the rising prevalence, this burden will only worsen unless effective measures to address the same are put in place.

P-27

Bariatric And Metabolic Surgery In India - Efficacy And Safety Of Minimally Invasive Procedures

1 2 2 3 4 1 1 1 1Wojciechowski P , Metz L , Mapari J , Jain M , Neoh K , Caban A , Gaweska M , Gomulka A , Plisko R , Wladysiuk 1 1M , Rys P

1 2 3HTA Consulting, Krakow, Poland, Johnson & Johnson Medical Asia-Pacific, Singapore, Singapore, Johnson & 4Johnson Medical, New Delhi, India, Johnson & Johnson Medical Asia-Pacific, Petaling Jaya, Malaysia

Abstract

Objectives: Obesity and type 2 diabetes mellitus (T2DM) are major health issues in developing countries contributing to increased morbidity and mortality. Bariatric surgery is an effective procedure leading to durable weight loss in morbidly obese patients, while metabolic surgery aims at resolving T2DM. The objective of our study was to assess the efficacy and safety of those procedures in Indians.

Methods: A comprehensive search was performed in PUBMED and websites of Indian medical databases and journals (www.indmed.org, www.dmri.in, www.nmji.in, www.japi.in). Studies met the inclusion criteria if they enrolled Indian patients with or without T2DM undergoing following laparoscopic procedures: sleeve gastrectomy, Roux-en-Y gastric bypass, adjustable gastric banding, single-incision sleeve gastrectomy.

Results: Our search retrieved nine studies including morbidly-obese subjects (978 patients) of which three enrolled exclusively T2DM patients (N = 91). One study assessing diabetics with non-morbid obesity(15 patients) was also retrieved.Bariatric surgery in patients with morbid obesityresults inpostoperative excess weight loss ranging from 59% to 80% after 12-months depending on procedure. One year following surgery T2DM resolved in 73%-100% patients, dyslipidemia was resolved in 30-100% patients and hypertension was improved in 60-95% individuals. Moreover, at the same time joint pain was reduced in 57-97% patients and sleep apnea in 100% subjects. The incidence of asthma and depression were also reduced following bariatric/metabolic surgery. Rates of postoperative complications were generally low and only one death was reported due to pulmonary embolism. In non-morbidly obese patients metabolic surgery leadsto a complete T2DM resolution within three months, significant reduction of systolic blood pressure (-20 mmHg, p<0.001) and total cholesterol (-40 mg/dL, p<0.001) together with noticeably increase of good cholesterol - HDL (+13mg/dL; p<0.001).

Conclusions: Bariatric and metabolic procedures are effective in both weight reduction as well as improvement or resolution of T2DM. Those procedures are safe and beneficial in patients with morbid- as well as non-morbid obesity, particularly with T2DM.

P-28

What Can Radio Frequency Identification (RFID) Do for Pharmaceutical?Vaibhav Gupta,

Delhi Institute of Pharmaceutical Sciences and Research, New Delhi



60

Abstract:

The needs to reduce medication errors, improve patient compliance, and minimize counterfeiting have boosted interest in automatic identification technology among regulators and manufacturers. Although bar coding offers many benefits and will no doubt be more widely used as pharmaceutical companies improve product tracking and tracing capability, another technology, radio frequency identification (RFID), waits in the wings. RFID tags consist of a chip to carry the data and an antenna to transmit it. Tags can be passive or active. Passive tags rely on a radio frequency field generated by a reader to transmit data, and active tags include a power source so the tag can transmit information continuously or at preset intervals. Software is required to organize the data collected and to link to other systems such as patient care, warehouse management, transportation management, or enterprise resource planning (ERP). This poster will give an overview of just how RFID will play such a big role in the pharmaceutical world and how it will be implemented. Also about some of the companies those have already started using RFID and their results. Concluding with the future of RFID in this world.

P-29

Roles & Responsibilities of Ethics Committee for Clinical TrialAbhay Srivastava, S.K. Gupta*

Department of Clinical Research, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi, Pushp Vihar, Sec-3, New Delhi-110017, India

Abstract:

As per WHO definition, a Clinical Trial is any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome. The four main principles of Biomedical Ethics are:-Autonomy, Non-Maleficence, Beneficence & Justice. Revised ICMR Code is the statement of Ethical Guidelines for Biomedical Research on Human Participants.To safeguard the welfare and the rights of the participants, it is mandatory that all proposals on biomedical research involving human participants should be cleared by an appropriately constituted Institutional Ethics Committee (IEC), also referred to as Institutional Review Board (IRB). The chief objectives of every IEC protocol review are to verify the ethics of the research. It also promotes fully-informed and voluntary participation by subjects, who are capable of making such choices (in case that is not possible, informed permission is obtained by a person authorized to act on behalf of the subject), and ensure maximum safety of subjects. Responsibilities of IEC are to protect the dignity, rights and well-being of the potential research participants, to ensure that universal ethical values and international scientific standards are expressed and to assist in the development and the education of a research community responsive to local health care requirements. It also specifies that special attention should be given to trials including vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension. The primary ethical principles in subject review are outlined in the Belmont Report. The selection of subjects should be consistent with fair or just distribution of risks and benefits. The Quorum, (as per revised Schedule Y of Drugs & Cosmetics Act, 1940)constitutes one basic medical scientist (pharmacologist),one clinician, one legal expert or retired judge, one social scientist/ representative of non-governmental organization/Philosopher/ ethicist/ theologian or a similar person & one lay person from the community. IECs are generally used for research in the fields of health, social sciences, and psychology.

P-30

Novel Transfersomal Carrier for Treating OsteoarthritisSetareh Barani and Saima Amin*

*Assistant Professor, Dept. of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi-110062. Email: [email protected]



61

Abstract:

Introduction: Transfersomes are the ultra flexible lipid vesicles for systemic absorption of poorly water soluble drugs such as piroxicam through skin.

Materials and Method: Transfersomes of piroxicam were prepared by conventional rotary evaporation sonication method for enhanced skin absorption. Soya phosphatidyl choline (75-95mg) was melted, dissolved in the solvent and sodium cholate (5-25 mg) was then added. The resulting solution was added to 2 ml mixture of methanol and chloroform (1:1). The solvent was removed at 40oC under reduced pressure until a thin film was obtained. The resulting film was then dried over night for complete removal of solvent. The film was then hydrated with 5 ml of 0.02 M phosphate buffer (pH 6.5) for 1 h in the rotary evaporator that gave transfersomal suspension system.

Results: Piroxicam transefersome showed 100.18% entrapment efficiency, vesicle size of 91.4 nm and the spherical shape. The transferosomal gel prepared by dispersion method showed uniform content dispersion, good spreadability and homogeneity, was non skin irritant and had good skin retention. The gel revealed a flux of 73.16µg/cm2/h and permeability coefficient of 3.656×102 cm/h with 14 folds increase in transdermal flux than the marked gel. The enhancement in transdermal permeation was attributed to hydration gradient built up across the skin as well as thinning of the epidermis due to formulation components. The prepared formulation showed efficacy against iodoacetate induced knee osteoarthritis in albino wistar rat model.

Summary: Piroxicam transfersomal formulation holds promise for non invasive systemic absorption for treatment of osteoarthritis.

P-31

The Role of Quantitative Sensory Testing in Asymptomatic Diabetic Neuropathy and its relationship with HbA1c

Sakshi Popli, Dr. S. K. Gupta, Dr. Sujeet Jha, Dr. Swati WaghdhareDelhi Institute of Pharmaceutical Sciences and Research, Pushp Vihar, Sec-3, New Delhi-110017

Abstract:

Objective: Patients' with diabetic neuropathy may or may not show symptoms. If its progression is not stopped at the earliest, it may lead to foot ulceration and amputation. This study was conducted to assess the role of Quantitative Sensory Testing (QST) in detection of diabetic neuropathy. Glycated hemoglobin (HbA1c) and age are two of the major risk factors for diabetic neuropathy. So, relationship of thermal thresholds was seen with HbA1c as well as age.

Methodology: This was a retrospective observational study conducted on type 2 diabetic patients above 18 years who underwent QST using computer-driven Medoc TSA II NeuroSensory Analyzer system from a period of October 2011 to May 2012. The results of QST were compared to those of monofilament test.

Results: 99 patients (73 males, 26 females) with an average age 51.49±11.07 years (range: 18-76 years) were recruited in the study. The sensitivity and specificity of QST to determine warm sensation threshold, cold sensation threshold, heat pain threshold and cold pain threshold in comparison to monofilament test was found to be maximum in case of warm sensation threshold (86% and 94.5%, respectively). Cold sensation threshold was found to be inversely proportional to HbA1c (correlation= -0.0909) as well as age (correlation= -0.4395). It was also seen that cold sensation threshold was inversely proportional to age (correlation= -0.2143) and heat pain threshold was directly proportional to age (correlation=0.2698).

Conclusion: Taking into consideration, the high sensitivity and specificity of quantitative sensory testing in case of warm sensation threshold and limitations of our study, we conclude that quantitative sensory testing can be of use in detecting diabetic peripheral neuropathy if used in proper way.



62

P-32

Regulatory Trends in Nutraceuticals and Value based Pricing of Nutraceuticals v/s Pharmaceuticals

Divya Ahuja, Prof D.P. PathakDepartment of Pharmaceutical Chemistry, Delhi Institute of Pharmaceutical Sciences and Research, Pushp vihar

Sec-3, M.B Road Delhi-17

Nutraceutical, a combination of the words “nutrition” and “pharmaceutical”, is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease. Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages. India accounts for less than 0.9% of the world nutraceuticals market. In USA, only those nutraceuticals products that claim to cure, mitigate or prevent a disease are regulated by Food, Drug and Cosmetic Act of USA else nutraceuticals products can be marketed as dietary supplement as a OTC product. In the absence of clear guidelines certain nutraceuticals are categorized as drugs or foods in India. Vitamin supplements that have ingredients of a drug also come under the purview of Drugs and Cosmetics act since there is no quality or price control for such supplements outside the act .This lead to ambiguity and so many companies are marketing vitamins under different prices ,under separate licenses of dietary supplements and drugs. Medicine whether in the form of health supplements or pharmaceuticals is big business indeed. The pricing of certain nutraceutical products is very high and hence many such products are beyond the range of average consumer. The present survey compares certain nutraceutical products to the product containing the same ingredient marketed in the form of pharmaceutical and concludes that nutraceutical products are much costlier than same as a pharmaceutical product.

TRANSDERMAL DRUG DELIVERY VIA PRONIOSOMAL GEL SYSTEM

DR. Meenakshi K. Chauhan, Ashwani Singh Rawat, Anubha Mahajan*, ArunaDelhi Institute of Pharmaceutical Sciences and Research, PushpVihar, Delhi-17

Abstract

Skin is one of the key sites for non-invasive delivery of drugs into the body but the major hindrance to the route is its impermeability. Studies have shown that compounds with a molecular weight of 500 Da cannot cross the skin. Various novel methods have been developed to enhance the transport of such large molecular weight drugs into or through the skin including vesicular systems (niosomes, liposomes). But the main drawback with their development is their instability at both industrial and clinical level. New evolving concept of provesicular system is one way to edge over this problem. They have high entrapment efficiency over other conventional systems. Proniosomal gel is a compact semi-solid liquid crystalline gel made of non-ionic surfactants. It is formed by dissolving the surfactant in small amount of suitable solvent and aqueous phase. The so formed crystalline gel, on hydration readily transforms into niosomes. The poster gives a complete outline of proniosomal gel as a drug carrier through transdermal route.

Keywords: Provesicular systems, drug delivery, niosomes, transdermal delivery

Abstract

P-33



63

Patron

President

President Elect

Vice Presidents

Secretary

Joint Secretary

Treasurer

Ranjit Roy ChaudharyUNESCO Professor, New Delhi

Suresh K. Gupta DIPSAR, New Delhi

Jawahar S. BapnaSMS Medical College, Jaipur

Yogendra K. GuptaAIIMS, New Delhi

Chandrashekhar Potkar

Pfizer Inc., Mumbai

Anita KotwaniVP Chest Institute, New Delhi

Pramil TiwariNIPER, Mohali

Nirmal K. GurbaniIIHMR, Jaipur

ISPOR India ChapterISPOR India Chapter

CIEO TS Y L FA ON R O PI HT AA RN MRET CNI O• ECH OC NR A OE MSE ICR SS AE NM DO C OT U

AExecutive Committee

Past President

Deepak G. Shewade, Puducherry

Divya Mishra, Mumbai

Subhash C. Mandal, Kolkata

Trupti K. Swain, Cuttack

Ambrish Joshi, Bangalore

Urmila Thatte, Mumbai

Sanjiv Saxena, Hyderabad

Nirmala Rege, Mumbai

Nayanabhirama Udupa, Manipal

Harish Narula, Mumbai

SUPPORTING ORGANISATIONS

Department of Science & Technology, Govt. of India

Indian Council of Medical Research

Society for Promotional of health & Environment

Indian Pharmacological Society, Delhi Branch

International Academy of Cardiovascular Sciences

Hospital Pharmacy Foundation

Alliance for the Prudent Use of Antibiotics - India

HOSPITAL

FOUNDATIONPHARMACY

PRIN

T M

EDIA

- 01

1-26

2221

42, 9

8107

9229

4

"Educational grant received from Pfizer Ltd., Indiais gratefully acknowledged"

PROGRAM AND SCHEDULE OF EVENTS Mehdi, Additional Professor, PGI, Chandigarh Assuring Quality in...

Documents

Transcript of PROGRAM AND SCHEDULE OF EVENTS Mehdi, Additional Professor, PGI, Chandigarh Assuring Quality in...