PHARMACOVIGILANCE IN
INDIA-PRESENT & FUTURE
PROSPECTS
DR.NAGARAJA PRASAD.S
ASSISTANT PROFESSOR
DEPT OF PHARMACOLOGY
S.I.M....
• PHARMACOVIGILANCE :
“SCIENCE & ACTIVITIES RELATING TO THE
DETECTION, ASSESSMENT, UNDERSTANDING
& PREVENTION OF ADVERSE E...
INTRODUCTION
• INDIA DID NOT HAVE ANY FORMAL PVG
SYSTEM IN THE PAST TO DETECT ADVERSE
REACTIONS TO DRUGS AS ONLY FEW DRUGS...
• FORMAL PVG ACTIVITIES WERE INITIATED IN
INDIA AROUND 1986.
• IN 1997 INDIA JOINED THE ADVERSE DRUG
REACTION MONITORING P...
• THE NPP WAS BASED ON THE
RECOMMENDATIONS MADE IN THE WHO
DOCUMENT TITLED “ SAFETY MONITORING
OF MEDICINAL PRODUCTS-GUIDE...
• UNDER THE NPP A NPAC WAS CREATED
UNDER THE CHAIRMANSHIP OF DCGI &
APPROVED BY MINISTRY OF HEALTH & FAMILY
WELFARE VIDE O...
• HOWEVER DUE TO SOME TECHNICAL
DIFFICULTIES THE NPP HAD TO BE CLOSED IN
2008.
• IT WAS AGAIN RESURRECTED AS THE
PHARMACOV...
• UNDER THE PvPI- AIIMS, NEW DELHI WAS THE
NATIONAL CO-ORDINATING CENTRE; WITH
TWO ZONAL CENTRES ; FIVE REGIONAL
CENTRES &...
• IN ORDER TO ENSURE IMPLEMENTATION OF
THE PROGRAMME IN A MORE EFFFECTIVE
WAY THE NCC AT AIIMS NEW DELHI WAS
SHIFTED TO IN...
MISSION
• TO SAFEGUARD THE HEALTH OF THE INDIAN
POPULATION BY ENSURING THAT THE
BENEFITS OF USE OF MEDICINES OUTWEIGH
THE ...
VISION
• TO IMPROVE PATIENT SAFETY & WELFARE IN
THE INDIAN POPULATION BY MONITORING
THE DRUG SAFETY & THEREBY REDUCING THE...
OBJECTIVES
• To create a nation-wide system for patient safety reporting.
• To identify & analyse the new signal(ADR) from...
SHORT TERM GOALS
• To develop & implement pharmacovigilance
system in india.
• To enrol initially all MCI approved medical...
LONG TERM GOALS
• To expand the pvg programme to all hospitals
(govt & private) & centres of public health
programmes loca...
The programme will be administered &
monitored by the following two committees:
• Steering committee.
• Strategic advisor...
Technical support will be provided by the
following panels:
• Signal review panel
• Core training panel
• Quality review ...
ROADMAP FOR PvPI
The ADR reports will be collected from the
following centres:
• MCI approved medical colleges & hospitals
• Private hospi...
Composition of the working group
Pharmacovigilance programme of
india
Secretary cum scientific director-
Indian pharmacop...
Three nominees of drugs controller
general(india)-members
1)Mr.A.K.Pradhan; Dy.drugs controller; CDSCO
headquarter, FDA b...
 A nominee from a medical institution run by central
government (to be nominated by the chairperson, steering
committee)-...
 A nominee from a pharmacy institution ( to be nominated
by the chairperson, steering committee)
• Dr.sanjay singh; Profe...
What to report?
• All adverse events suspected to be caused by new drugs &
drugs of current interest(published by CDSCO fr...
Who can report?
Any health care professional
• doctors
• dentists
• nurses
• pharmacists.
Where to report?
Completed ADR reporting forms shall be
returned to Pvg centre from where it was
received.
What happens to the information
submitted?
• Information shall be handled in strict
confidence.
• Shall be Forwarded to hi...
Also it can lead to the following:
• Follow up investigations
• Appropriate package insert changes
• Educational initiati...
Minimum Requirements to report
ADR
• An identifiable pt
• A suspect medicinal product
• An identifiable reporting source
•...
PVPI, NCC GHAZIABAD,INDIA.
CURRENT STATUS OF PvPI
• Total number of ADR monitoring centres: 90.
• Total number of proposed ADR monitoring
centres: - ...
NUMBER OF ADR MONITORING
CENTRES
• SOUTH ZONE-25 AMC’S
• NORTH ZONE-28 AMC’S
• WEST ZONE-20 AMC’S
• EAST ZONE-17 AMC’S.
IN KARNATAKA THE RECOGINISED ADR
MONITORING CENTRES ARE AS FOLLOWS:
• St.Johns medical college:Dr.PadminiDevi
• Bangalore...
• JSS Medical College Hospital- Dr.Parthasarathi G
• Belgaum Institute Of Medical Sciences- Dr.Basavaraj
Kotintot.
• Karna...
FUTURE PROSPECTS
&
DEVELOPMENTS
HEAMOVIGILANCE & BIOVIGILANCE
• Was launched on 10th dec 2012
• NIB is the co-ordinating centre for BvPI .
• The programme...
Defn-HEMOVIGILANCE
• A set of surveillance procedures covering the
whole transfusion chain ( from collection of
blood & it...
THANK YOU
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
pharmacovigilance in india-by dr.nagaraja prasad.s
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pharmacovigilance in india-by dr.nagaraja prasad.s

  1. 1. PHARMACOVIGILANCE IN INDIA-PRESENT & FUTURE PROSPECTS DR.NAGARAJA PRASAD.S ASSISTANT PROFESSOR DEPT OF PHARMACOLOGY S.I.M.S,SHIMOGA.
  2. 2. • PHARMACOVIGILANCE : “SCIENCE & ACTIVITIES RELATING TO THE DETECTION, ASSESSMENT, UNDERSTANDING & PREVENTION OF ADVERSE EFFECTS OF DRUGS OR ANY OTHER DRUG RELATED PROBLEM”.
  3. 3. INTRODUCTION • INDIA DID NOT HAVE ANY FORMAL PVG SYSTEM IN THE PAST TO DETECT ADVERSE REACTIONS TO DRUGS AS ONLY FEW DRUGS WERE DISCOVERED IN INDIA • INDIA’S REGULATORY AGENCIES BASED THEIR SAFETY ASSESSMENT OF DRUGS ON DATA DERIVED FROM LONG TERM USE IN US, EUROPE & JAPANESE MARKETS.
  4. 4. • FORMAL PVG ACTIVITIES WERE INITIATED IN INDIA AROUND 1986. • IN 1997 INDIA JOINED THE ADVERSE DRUG REACTION MONITORING PROGRAMME OF WHO. • THE NATIONAL PHARMACOVIGILANCE PROGRAMME (NPP) WAS LAUNCHED BY CDSCO ON NOV 23,2004 WHICH BECAME OPERATIONAL FROM JAN 1,2005.
  5. 5. • THE NPP WAS BASED ON THE RECOMMENDATIONS MADE IN THE WHO DOCUMENT TITLED “ SAFETY MONITORING OF MEDICINAL PRODUCTS-GUIDELINES FOR SETTING UP & RUNNING A PVG CENTRE”.
  6. 6. • UNDER THE NPP A NPAC WAS CREATED UNDER THE CHAIRMANSHIP OF DCGI & APPROVED BY MINISTRY OF HEALTH & FAMILY WELFARE VIDE ORDERS DATED 12TH MARCH 2004.
  7. 7. • HOWEVER DUE TO SOME TECHNICAL DIFFICULTIES THE NPP HAD TO BE CLOSED IN 2008. • IT WAS AGAIN RESURRECTED AS THE PHARMACOVIGILANCE PROGRAMME OF INDIA(PvPI) IN 14/07/2010 DUE TO THE DEDICATED EFFORTS OF PERSONNEL WORKING IN THIS FIELD.
  8. 8. • UNDER THE PvPI- AIIMS, NEW DELHI WAS THE NATIONAL CO-ORDINATING CENTRE; WITH TWO ZONAL CENTRES ; FIVE REGIONAL CENTRES & AN INCREASING NUMBER OF PERIPHERAL CENTRES.
  9. 9. • IN ORDER TO ENSURE IMPLEMENTATION OF THE PROGRAMME IN A MORE EFFFECTIVE WAY THE NCC AT AIIMS NEW DELHI WAS SHIFTED TO INDIAN PHARMACOPOEIA COMMISSION, GHAZIABAD ON 15/04/2011.
  10. 10. MISSION • TO SAFEGUARD THE HEALTH OF THE INDIAN POPULATION BY ENSURING THAT THE BENEFITS OF USE OF MEDICINES OUTWEIGH THE RISKS ASSOCIATED WITH ITS USE.
  11. 11. VISION • TO IMPROVE PATIENT SAFETY & WELFARE IN THE INDIAN POPULATION BY MONITORING THE DRUG SAFETY & THEREBY REDUCING THE RISK ASSOCIATED WITH USE OF MEDICINES.
  12. 12. OBJECTIVES • To create a nation-wide system for patient safety reporting. • To identify & analyse the new signal(ADR) from the reported cases. • To analyse the benefit risk ratio of marketed medications. • To generate evidence based information on safety of medicines. • To support the regulatory agencies in the decision making process on use of medicines. • To communicate the safety information on use of medicines to various stakeholders to minimise the risk. • To emerge as a national centre of excellence for pharmacovigilance activities. • To collaborate with other national centres for the exchange of information & data management. • To provide training & consultancy support to other national pharmacovigilance centres located across globe.
  13. 13. SHORT TERM GOALS • To develop & implement pharmacovigilance system in india. • To enrol initially all MCI approved medical colleges in the programme covering north, south, east & west of india. • To encourage healthcare professionals in reporting of adverse reaction to drugs, vaccines, medical devices & biological products. • Collection of case reports & data.
  14. 14. LONG TERM GOALS • To expand the pvg programme to all hospitals (govt & private) & centres of public health programmes located across india. • To develop & implement electronic reporting system( e-reporting). • To develop reporting culture amongst healthcare professionals. • To make ADR reporting mandatory for healthcare professionals.
  15. 15. The programme will be administered & monitored by the following two committees: • Steering committee. • Strategic advisory committee.
  16. 16. Technical support will be provided by the following panels: • Signal review panel • Core training panel • Quality review panel.
  17. 17. ROADMAP FOR PvPI
  18. 18. The ADR reports will be collected from the following centres: • MCI approved medical colleges & hospitals • Private hospitals • Public health programmes • Autonomous institutions(ICMR etc).
  19. 19. Composition of the working group Pharmacovigilance programme of india Secretary cum scientific director- Indian pharmacopoeia commission Ghaziabad(U.P)----Dr. G.N.Singh; Chairman ex-officio. Head of department, department of pharmacology, AIIMS, New Delhi- Prof y. k. gupta ; member.
  20. 20. Three nominees of drugs controller general(india)-members 1)Mr.A.K.Pradhan; Dy.drugs controller; CDSCO headquarter, FDA bhawan, new delhi. 2)Dr.G.Parthasarathy, Professor & Head Pharmacy practices; JSS college of pharmacy; Mysore. 3)Dr.Bikas Medhi; Dept of pharmacology; PGIMER Chandigarh.
  21. 21.  A nominee from a medical institution run by central government (to be nominated by the chairperson, steering committee)-member • Dr. shakthi kumar gupta; HOD, Hospital administration & MS; AIIMS new delhi.  Two nominees from medical institutions run by the state government(to be nominated by chairperson, steering committee)-members. • Dr.Nandhini; Head, Dept of pharmacology; madras medical college Chennai. • Dr.Urmila Thatte, Dept of Clinical Pharmacology; Seth G Medical College & KEM hospital, panvel , Mumbai.
  22. 22.  A nominee from a pharmacy institution ( to be nominated by the chairperson, steering committee) • Dr.sanjay singh; Professor of pharmaceutics; Institute of technology; Banaras hindu university, Varanasi; member  A nominee from a nursing institution ( to be nominated by chairperson, steering committee) • Shri t.dileep kumar ; President; Indian nursing council ; kotla road, new delhi; member.  Officer incharge (pharmacovigilance cell) Indian pharmacopoeia commission( to be nominated by chairperson working group) • Dr.jai prakash;Principal scientific officer; Member secretary.
  23. 23. What to report? • All adverse events suspected to be caused by new drugs & drugs of current interest(published by CDSCO from time to time) • All suspected drug interactions • Any Drug or adverse event leading to:  Death  Life threatening reaction  Hospitalisation  disability  Congenital anomaly  required intervention to prevent permanent impairment or damage.
  24. 24. Who can report? Any health care professional • doctors • dentists • nurses • pharmacists.
  25. 25. Where to report? Completed ADR reporting forms shall be returned to Pvg centre from where it was received.
  26. 26. What happens to the information submitted? • Information shall be handled in strict confidence. • Shall be Forwarded to higher pvg centres where causality analysis shall be done, data analysed statistically & forwarded to global pvg database managed by WHO Uppsala monitoring centre in Sweden.
  27. 27. Also it can lead to the following: • Follow up investigations • Appropriate package insert changes • Educational initiatives on proper use of medicines. • Changes in the scheduling or manufacture of medicine to make them safer.
  28. 28. Minimum Requirements to report ADR • An identifiable pt • A suspect medicinal product • An identifiable reporting source • An event or outcome
  29. 29. PVPI, NCC GHAZIABAD,INDIA.
  30. 30. CURRENT STATUS OF PvPI • Total number of ADR monitoring centres: 90. • Total number of proposed ADR monitoring centres: - 47(govt-27; private-20) • Number of ADRs committed by NCC to WHO- UMC- 35,008. • Number of ADRs under assessment of NCC- 4308. • Number of reports reverted back to AMCs- 37. • Total number of ADRs under PvPI- 39353.
  31. 31. NUMBER OF ADR MONITORING CENTRES • SOUTH ZONE-25 AMC’S • NORTH ZONE-28 AMC’S • WEST ZONE-20 AMC’S • EAST ZONE-17 AMC’S.
  32. 32. IN KARNATAKA THE RECOGINISED ADR MONITORING CENTRES ARE AS FOLLOWS: • St.Johns medical college:Dr.PadminiDevi • Bangalore Medical college & research institute- Dr. C.R. Jayanthi. • Kasturba Medical college, Manipal- Dr.K.L.Bairy. • Vydehi institute of medical sciences & research centre - Dr.Prathibha Nadig. • SDS tuberculosis research centre & Rajiv Gandhi institute of chest diseases- Dr.Shashidhar buggi.
  33. 33. • JSS Medical College Hospital- Dr.Parthasarathi G • Belgaum Institute Of Medical Sciences- Dr.Basavaraj Kotintot. • Karnataka Institute Of Medical Sciences- Dr.Janaki.R.Torvi. • Vijayanagara Institute of Medical Sciences- Dr.Laxminarayana. • Mandya Institute of Medical Sciences- Dr.Nagabhushan. • Bidar Institute of Medical Sciences- Dr. B.O. Hanumanthappa.
  34. 34. FUTURE PROSPECTS & DEVELOPMENTS
  35. 35. HEAMOVIGILANCE & BIOVIGILANCE • Was launched on 10th dec 2012 • NIB is the co-ordinating centre for BvPI . • The programme has currently 60 medical colleges in its network & is growing further.
  36. 36. Defn-HEMOVIGILANCE • A set of surveillance procedures covering the whole transfusion chain ( from collection of blood & its components to the follow up of recipients) intended to collect & assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products & to prevent their occurrence or recurrence.
  37. 37. THANK YOU
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