PHARMACOVIGILANCE IN INDIA-PRESENT & FUTURE

PROSPECTSDR.NAGARAJA PRASAD.SASSISTANT PROFESSOR

DEPT OF PHARMACOLOGYS.I.M.S,SHIMOGA.

• PHARMACOVIGILANCE : “SCIENCE & ACTIVITIES RELATING TO THE

DETECTION, ASSESSMENT, UNDERSTANDING & PREVENTION OF ADVERSE EFFECTS OF DRUGS OR ANY OTHER DRUG RELATED PROBLEM”.

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.

• 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.

• 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 2004.

• 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.

• 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.

• 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.

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.

VISION

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

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.

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.

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.

The programme will be administered & monitored by the following two committees:

• Steering committee.• Strategic advisory committee.

Technical support will be provided by the following panels:

• Signal review panel• Core training panel• Quality review panel.

ROADMAP FOR PvPI

The ADR reports will be collected from the following centres:

• MCI approved medical colleges & hospitals• Private hospitals• Public health programmes• Autonomous institutions(ICMR etc).

Composition of the working groupPharmacovigilance 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.

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.

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.

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 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.

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 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

medicines.• Changes in the scheduling or manufacture of

medicine to make them safer.

Minimum Requirements to report ADR

• An identifiable pt• A suspect medicinal product• An identifiable reporting source• An event or outcome

PVPI, NCC GHAZIABAD,INDIA.

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.

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 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

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.

FUTURE PROSPECTS & DEVELOPMENTS

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.

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.

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