pharmacovigilance in india-by dr.nagaraja Prasad.s

1. PHARMACOVIGILANCE IN
INDIA-PRESENT & FUTURE
PROSPECTS
DR.NAGARAJA PRASAD.S
ASSISTANT PROFESSOR
DEPT OF PHARMACOLOGY
S.I.M.S,SHIMOGA.

2. • PHARMACOVIGILANCE :
“SCIENCE & ACTIVITIES RELATING TO THE
DETECTION, ASSESSMENT, UNDERSTANDING
& PREVENTION OF ADVERSE EFFECTS OF
DRUGS OR ANY OTHER DRUG RELATED
PROBLEM”.

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.

5. • 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.

6. • 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”.

7. • 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.

8. • 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.

9. • 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.

11. • 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.

12. 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.

13. VISION
• TO IMPROVE PATIENT SAFETY & WELFARE IN
THE INDIAN POPULATION BY MONITORING
THE DRUG SAFETY & THEREBY REDUCING THE
RISK ASSOCIATED WITH USE OF MEDICINES.

14. 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.

15. 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.

16. 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.

19. The programme will be administered &
monitored by the following two committees:
• Steering committee.
• Strategic advisory committee.

20. Technical support will be provided by the
following panels:
• Signal review panel
• Core training panel
• Quality review panel.

23. ROADMAP FOR PvPI

24. The ADR reports will be collected from the
following centres:
• MCI approved medical colleges & hospitals
• Private hospitals
• Public health programmes
• Autonomous institutions(ICMR etc).

26. 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.

27. 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.

28.  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.

29.  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.

30. 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.

31. Who can report?
Any health care professional
• doctors
• dentists
• nurses
• pharmacists.

32. Where to report?
Completed ADR reporting forms shall be
returned to Pvg centre from where it was
received.

33. 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.

34. 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.

35. Minimum Requirements to report
ADR
• An identifiable pt
• A suspect medicinal product
• An identifiable reporting source
• An event or outcome

38. PVPI, NCC GHAZIABAD,INDIA.

39. 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.

40. 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.

41. 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.

42. • 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.

43. FUTURE PROSPECTS
&
DEVELOPMENTS

44. 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.

45. 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.

50. THANK YOU