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GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Global Clinical Research & Pharmacovigilance
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GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Global Clinical Research & Pharmacovigilance






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GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Global Clinical Research & Pharmacovigilance GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Global Clinical Research & Pharmacovigilance Presentation Transcript

  • GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Global Clinical Research & Pharmacovigilance
  • Overview…
    • Benefits of developing PV in India
    • Analyzing the current and the future of PV in India
    • Demand for efficient PV
  • Benefits of developing pharmacovigilance in India
  • Incredible India…
    • Over a billion population & growing
    • Indian Economy growing at 9%
    • 2 nd largest English speaking Population in the world
    • Clinical Research Hub
    • Regulatory Overhaul
    • Disease burden of the world eg. Diabetes, CV, Oncology etc
    • Fourth largest exporter by volume of drugs and biologics, especially generics, to the US.
    • USFDA office in Delhi, Mumbai next
  • India Today…
    • Pharmacovigilance is still in its infancy in India
    • Major advancements have taken place in the Western countries, not much has been achieved in India.
    • More clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product.
    • Enable integration of good pharmacovigilance practice in the processes and procedures
      • regulatory compliance and
      • enhance clinical trial safety and postmarketing surveillance.
  • Challenges…
    • the problems of a large population that is predominantly rural,
    • extensive use of traditional medicines,
    • poor spontaneous reporting,
    • lack of physician and consumer awareness,
    • rapid introduction of several new molecules, and
    • inadequate post marketing surveillance.
  • Challenges…
    • There is a surfeit of drug brands-more than 6,000 licensed drug manufacturers and over 60,000 branded formulations.
    • All medicines have potential risks as well as benefits.
    aim : is to protect public health by identifying, evaluating and minimizing safety issues
  • Analyzing the current & future of PV In India
  • Live Mint 27 Jul 2008
  • PHARMACOVIGILANCE IN INDIA 1986 ADR Monitoring System which contained 12 regional centers was proposed 1997 - India joined the World Health Organization (WHO) Adverse Drug Reaction Monitoring Program based in Uppsala, Sweden. -National Pharmacovigilance Centre (AIIMS, New Delhi) -WHO centre (KEM Hospital, Mumbai) -WHO centre (JLN Hospital, Aligarh Muslim University Unsuccessful attempt 01 Jan 2005 - the WHO-sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational.
    • Objectives
    • the short-term objective is to foster a reporting culture, the intermediate objective is to involve a large number of healthcare professionals in the systems in information dissemination and
    • the long-term objective is for the program to be a benchmark for global drug monitoring.
    Hence from 1986 – Till Date, things have definitely changed for the better but at a very slow pace. the questions that arise are whether the strategy should be changed and if so, how? ?
  • National Pharmacovigilance Programme
    • Zonal Centers : 2
    • Regional Centers :5
    • Peripheral Centers : 28
  • Asian J of Pharmaceutical & Clinical Research 2009;2(2): 10 - 14
  • Asian J of Pharmaceutical & Clinical Research 2009;2(2): 10 - 14
  • IJP 2008;40(1): S31- 34 From BJ Medical College, A’bad
  • Ground reality in ADR detection
    • Lack of training and emphasis on ADR during undergraduate program
    • Diagnosis and management of diseases a priority for practicing doctors
    • Lack of time in busy schedule
    • Parents report ADE that may not be true and is often ignored or drug changed
    • Denial for fear of allegation
    • No mechanism for reporting even if detected
    Courtesy : Dr YK Amdekar (IDMA PV Conf, 2009 Mumbai)
  • Where does fault lie?
    • Increasing availability of drugs
      • Too many drugs and irrational combinations
      • Aggressive marketing
    • Irrational practice
      • Treatment without provisional diagnosis
      • Wrong choice and incorrect dose
      • Lack of documentation
      • Resultant medical errors leading to ADEs and not necessarily ADRs
      • Lack of culture of rational practice and following protocols in spite of legal threat
    Courtesy : Dr YK Amdekar (IDMA PV Conf, 2009 Mumbai)
  • Where does fault lie?
    • Adequate sharing of information between stakeholders – Poor
    • No rapport with practising Physicians & Peripheral centers
    Courtesy : Dr YK Amdekar (IDMA PV Conf, 2009 Mumbai)
  • Solutions to minimise ADRs
    • Health authority’s role to make compulsory recertification of medical practitioners with standardised CMEs of practical utility
    • Academia’s role to implement the program
    • Drug regulatory authority’s role to weed off irrational drugs
    • Manufacturer’s role to monitor and moderate marketing practices
    Courtesy : Dr YK Amdekar (IDMA PV Conf, 2009 Mumbai)
  • Robust PV System in India
    • With more and more clinical research now being conducted in India, it will be worthwhile for the DCGI to invest in a robust pharmacovigilance system , which will enable assessors and decision makers to analyze safety data and take regulatory decisions without the need to depend on other countries.
    • DCGI should take some tough decisions and make commitments to make pharmacovigilance mandatory and start the culture of pharmacovigilance inspections.
    • Pharmaceutical companies will need to show both regulators and consumers that they are doing everything possible to assure drug safety, while finding more effective approaches to manage drug safety data.
    • An integrated approach to AE data systems and pharmacovigilance along with appropriate business processes need to be developed and put in place.
    • The companies need to be reassured that by reporting AEs and continuously monitoring for signals and developing risk management plans for products, they can actually still keep marketing their product.
    • Reporting of ADRs after marketing should be actively encouraged and should involve all those concerned including doctors, pharmacists, nurses, patients and pharmaceutical companies.
    • To enhance and facilitate this, a culture of learning about pharmacovigilance should start early in the professional training of healthcare students . This will help healthcare professionals to understand the subject and also create awareness by giving adequate information to patients at the start of any treatment about the potential benefits and risks of the therapy.
    • Healthcare professionals, consumer groups, NGOs and hospitals should appreciate that there is now a system in place to collect and analyze adverse event data.
  • Soliciting ADR reporting from private practitioners
    • Semi-voluntary strategy
    • Enlist volunteers for ADR monitoring
    • Short training for ADR detection and reporting with simple module
    • Restrict to commonly used few drugs
    • Role of IMA & other professional bodies
    Courtesy : Dr YK Amdekar (IDMA PV Conf, 2009 Mumbai)
    • Building and strengthening a robust PV system
    • Mandatory Reporting and introducing PV Inspections
    • High level discussions with various stakeholders
    • Strengthen the DCGI office with trained scientific and medical assessors for pharmacovigilance
    • Creating a single country-specific adverse event reporting form to be used by all
    • Creating a clinical trial and post-marketing database for SAEs / SUSARs and ADRs for signal detection and access to all relevant data from various stakeholders
    • List all new drugs / indications by maintaining a standard database for every pharmaceutical company
    • Training programs – HCP, medical students, nursing and pharmacy graduates , Workers in rural areas
    • A uniform format for data collection and reporting needs to be designed
    • Active participation from industry, both domestic and multinational, in the drug safety monitoring during clinical trials and post marketing must be ensured.
    • Collaborating with pharmacovigilance organizations in enhancing drug safety
    • Building a network of pharmacovigilance and pharmaco-epidemiologists in India
    • A national database
  • Use of Media & Organizations
    • Education to public
    • Seminars, CMEs For Physicians
    • Role Of SoPI, ISCR,IDMA, OPPI
    • Media Workshop
  • THANK YOU !!!