pharmacovigilance in india-by dr.nagaraja prasad.s
INDIA-PRESENT & FUTURE
DEPT OF PHARMACOLOGY
• PHARMACOVIGILANCE :
“SCIENCE & ACTIVITIES RELATING TO THE
DETECTION, ASSESSMENT, UNDERSTANDING
& PREVENTION OF ADVERSE EFFECTS OF
DRUGS OR ANY OTHER DRUG RELATED
• 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.
• FORMAL PVG ACTIVITIES WERE INITIATED IN
INDIA AROUND 1986.
• IN 1997 INDIA JOINED THE ADVERSE DRUG
REACTION MONITORING PROGRAMME OF
• THE NATIONAL PHARMACOVIGILANCE
PROGRAMME (NPP) WAS LAUNCHED BY
CDSCO ON NOV 23,2004 WHICH BECAME
OPERATIONAL FROM JAN 1,2005.
• 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”.
• UNDER THE NPP A NPAC WAS CREATED
UNDER THE CHAIRMANSHIP OF DCGI &
APPROVED BY MINISTRY OF HEALTH & FAMILY
WELFARE VIDE ORDERS DATED 12TH MARCH
• HOWEVER DUE TO SOME TECHNICAL
DIFFICULTIES THE NPP HAD TO BE CLOSED IN
• 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.
• UNDER THE PvPI- AIIMS, NEW DELHI WAS THE
NATIONAL CO-ORDINATING CENTRE; WITH
TWO ZONAL CENTRES ; FIVE REGIONAL
CENTRES & AN INCREASING NUMBER OF
• 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.
• TO SAFEGUARD THE HEALTH OF THE INDIAN
POPULATION BY ENSURING THAT THE
BENEFITS OF USE OF MEDICINES OUTWEIGH
THE RISKS ASSOCIATED WITH ITS USE.
• TO IMPROVE PATIENT SAFETY & WELFARE IN
THE INDIAN POPULATION BY MONITORING
THE DRUG SAFETY & THEREBY REDUCING THE
RISK ASSOCIATED WITH USE OF MEDICINES.
• 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
• 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.
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
• Collection of case reports & data.
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
• To develop reporting culture amongst
• To make ADR reporting mandatory for
The programme will be administered &
monitored by the following two committees:
• Steering committee.
• Strategic advisory committee.
Technical support will be provided by the
• Signal review panel
• Core training panel
• Quality review panel.
The ADR reports will be collected from the
• MCI approved medical colleges & hospitals
• Private hospitals
• Public health programmes
• Autonomous institutions(ICMR etc).
Composition of the working group
Pharmacovigilance programme of
Secretary cum scientific director-
Indian pharmacopoeia commission
Head of department, department of
pharmacology, AIIMS, New Delhi-
Prof y. k. gupta ; member.
Three nominees of drugs controller
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;
3)Dr.Bikas Medhi; Dept of pharmacology;
A nominee from a medical institution run by central
government (to be nominated by the chairperson, steering
• 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
• Dr.Nandhini; Head, Dept of pharmacology; madras medical
• Dr.Urmila Thatte, Dept of Clinical Pharmacology;
Seth G Medical College & KEM hospital, panvel , Mumbai.
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.
What to report?
• All adverse events suspected to be caused by new drugs &
drugs of current interest(published by CDSCO from time to
• All suspected drug interactions
• Any Drug or adverse event leading to:
Life threatening reaction
required intervention to prevent permanent impairment or
Who can report?
Any health care professional
Where to report?
Completed ADR reporting forms shall be
returned to Pvg centre from where it was
What happens to the information
• Information shall be handled in strict
• 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.
Also it can lead to the following:
• Follow up investigations
• Appropriate package insert changes
• Educational initiatives on proper use of
• Changes in the scheduling or manufacture of
medicine to make them safer.
Minimum Requirements to report
• An identifiable pt
• A suspect medicinal product
• An identifiable reporting source
• An event or outcome
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-
• Number of ADRs under assessment of NCC- 4308.
• Number of reports reverted back to AMCs- 37.
• Total number of ADRs under PvPI- 39353.
NUMBER OF ADR MONITORING
• 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 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.
• JSS Medical College Hospital- Dr.Parthasarathi G
• Belgaum Institute Of Medical Sciences- Dr.Basavaraj
• Karnataka Institute Of Medical Sciences-
• Vijayanagara Institute of Medical Sciences-
• Mandya Institute of Medical Sciences-
• Bidar Institute of Medical Sciences-
Dr. B.O. Hanumanthappa.
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.
• 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.