Terms
of Reference for engagement of Peripheral Pharmacovigilance Centre under the
National Pharmacovigilance Programme
1.
Background
The
Government of India with the assistance of World Bank has initiated the
National Pharmacovigilance Programme. The
Central Drugs Standard Control Organization (CDSCO) is coordinating the
country-wide Pharmacovigilance programme under the aegis of DGHS, Ministry of
Health & Family Welfare, New Delhi.
With
the number of new drugs being regularly approved for marketing in India, there
is a need for a vibrant Pharmacovigilance system in the country to protect our
population from the potential harms that may be caused by some of these new
drugs. Besides, with the patent regime coming in force from 2005, it is widely
believed that India would become the global hub for new drug trials. These
situations make it pertinent for the Indian central drugs regulatory authority
to have a vibrant Pharmacovigilance system in the country.
The
programme shall be coordinated by CDSCO under the supervision of a National
Pharmacovigilance Advisory Committee which would monitor the program and also
recommend regulatory interventions based on the generated Adverse Drug
Reaction (ADR) data.
2.
Objective of the Assignment
Assignment: To manage the Peripheral Pharmacovigilance centre
The
overall objective as per the National Pharmacovigilance Programme will be:
1. To
monitor safety of the drugs and provide structured inputs for appropriate
regulatory interventions
2.
To create awareness about ADR monitoring in India
Peripheral centres will be the primary pharmacovigilance centres under the
National Pharmacovigilance Programme.
To
carry out the functions as envisaged in the “Protocol for the National
Pharmacovigilance Programme” a Coordinator will have to be designated who
will be in-charge of the pharmacovigilance activities at the designated
peripheral centre.
By accepting to participate
in the National Pharmacovigilance Programme all centres explicitly agree that
all pharmacovigilance activities at their institutions shall be performed in
strict consonance with the National Pharmacovigilance Programme appended here
(Coordinators of the centres and heads of the institutions are advised to
carefully go through the Protocol prior to joining the programme).
3.
Outline of tasks to be carried out
The National Pharmacovigilance Programme encourages the reporting of
all suspected
adverse reaction to drugs and other medicinal substances including
herbal, traditional or
alternative remedies. The reporting of seemingly insignificant or common
adverse reactions
would
be important since it may highlight a wide spread prescribing problem.
Peripheral
Centre is expected to carry out the following tasks:
|
S.
No. |
Task
|
|
1.
|
The
coordinator designated by CDSCO for the Peripheral Centre for the
program would ensure conformity of his functioning with the protocols
of National Pharmacovigilance program. |
|
2.
|
Collect
& collate minimum 30 Adverse Drug notifications and forward all
duly-filled ADE forms to Regional Centre |
|
3.
|
Carryout
special projects on drug safety at the request of the CDSCO. |
|
4.
|
Receive
funds from CDSCO |
|
5.
|
Maintain
the accounts as per the project requirements and as per your
institution’s systems and submission of audited statement of
accounts to Regional center. |
|
6.
|
Carry
out (and/or review) data causality analysis of all ADEs |
|
7.
|
To
receive blank ADE forms form Zonal or National Centre and acknowledge
the receipt |
|
8.
|
To
maintain log of all ADE forms and ADE notification forms received and
forwarded |
|
9.
|
Inculcate
/ foster the culture of ADE reporting / notification in health care
professionals by acknowledging the cooperation by the notifier and
share with the notifier relevant feedback. |
|
10.
|
Organize
and attend training programmes / interactive meetings of the National
Pharmacovigilance Programme. |
|
11.
|
To
provide updates, reports and such other information as may be required
by the National Pharmacovigilance Advisory Committee and to attend
their meetings when required. |
4.
Schedule of Performance of Tasks
The
duration of the assignment is four year (with a review at the end of every
year). The time schedule for performance of various tasks is detailed below:
|
S.
No. |
Task
|
Time
Schedule |
|
1.
|
The
coordinator designated by CDSCO for the Peripheral Centre for the
program would ensure conformity of his functioning with the protocols
of National Pharmacovigilance program. |
One
month from date of appointment |
|
2.
|
Collect
& collate minimum 30 Adverse Drug notifications and forward all
duly-filled ADE forms to Regional Centre |
Monthly |
|
3.
|
Carryout
special projects on drug safety at the request of the CDSCO. |
Ongoing |
|
4.
|
Receive
funds from CDSCO |
Ongoing |
|
5.
|
Maintain
the accounts as per the project requirements and as per your
institution’s systems and submission of audited statement of
accounts to Regional center. |
Quarterly |
|
6.
|
Carry
out (and/or review) data causality analysis of all ADEs |
Monthly |
|
7.
|
To
receive blank ADE forms form Zonal or National Centre and acknowledge
the receipt |
Monthly |
|
8.
|
To
maintain log of all ADE forms and ADE notification forms received and
forwarded |
Ongoing |
|
9.
|
Inculcate
/ foster the culture of ADE reporting / notification in health care
professionals by acknowledging the cooperation by the notifier and
share with the notifier relevant feedback. |
Ongoing |
|
10.
|
Organize
and attend training programmes / interactive meetings of the National
Pharmacovigilance Programme. |
6
months in addition to induction training |
|
11.
|
To
provide updates, reports and such other information as may be required
by the National Pharmacovigilance Advisory Committee and to attend
their meetings when required. |
Ongoing |
5.
Data services and Facilities to be provided by CDSCO
6.
Final Output that will be required
a)
Structured pharmacovigilance data based on the ADE forms collected
under the
program participants.
b)
A structured annual report describing smooth and efficient operation of
the program, in accordance with the Protocol.
7.
Financial support and Facilities to be provided by National
Pharmacovigilance Centre at CDSCO H.Q.
The
following financial support shall be provided by CDSCO:
1.
Expenditure on office operation for Peripheral center Rs. 15,000/- p.a.
2 AE Reporting
forms, various books and periodicals, MIS reporting forms shall
be
provided by
the CDSCO, which will also provide funds for zonal / regional /
peripheral
interaction
meetings twice a year.
8.
Review Committee
The
National Pharmacovigilance Advisory Committee (NPAC) will oversee the
performance of various Zonal, Regional and Peripheral Centres and will perform
the functions of “Review Committee” for this program.
The NPAC will also recommend possible regulatory measures based on
pharmacovigilance data received from various centres. The composition of the
NPAC is as under:
|
Chairperson |
Director
General Health Services |
|
Member
Secretary |
DCG(I) |
|
1.
ICMR |
D.
G., ICMR, New Delhi |
|
2.
AIIMS, New Delhi, Zonal Centre Coordinator |
Dr.
S. K. Gupta, Head of the Department of Pharmacology, AIIMS, New Delhi |
|
3.
SGC Medical College, Mumbai, Zonal Centre Coordinator |
Dr.
Nilima Kshirsagar, SGS Medical College (Mumbai) |
|
4.
Member, Pharmacology |
Dr.
Ranjit Roy Choudhary, NII, New Delhi Dr.
C. Adithan, Prof. Pharmacology JIPMER, Pondicherry |
|
5.
Forensic Medicine |
Dr.
T. D. Dogra, (AIIMS, New Delhi) |
|
6.
General Medicine |
Dr.
A. K. Agarwal (RML, New Delhi) Dr.
Anoop Mishra (AIIMS, New Delhi) |
|
7.
Clinical Pharmacology |
Dr.
S. D. Seth, Chair-in Clinical Pharmacology (ICMR, New Delhi) |
|
8.
Member, Pharmacy |
Mr.
Brijesh Regal, WHO Consultant New Delhi |
|
9.
Member, Toxicology |
Dr.
Y. K. Gupta, Director, (ITRC, Lucknow) |
|
10.
Member, Epidemiology |
Dr.
M. D. Gupte (ICMR Institute of Epidemiology, Chennai) |
|
11.
Member, Pathology |
Dr.
Kusum Verma Member Secretary, (AIIMS Ethics Committee, New Delhi) |
|
12.
Member, Drug Information |
Dr.
Pramil Tiwari (NIPER, Mohali) |
|
13.
Member, Phytotherapy |
Dr.
Urmila Thatte, Head of the Department of Pharmacology, B. L. Nair
Medical College Hospital, Mumbai |
7.
MIS Formats for Reporting by Zonal Centre to CDSCO
1.
Period of Report
2.
Number of notifications received in the preceding period
3.
Number of Reports made and number of serious or suspected serious AEs
reports, if any
4.
Number of serious or suspected serious AE reports forwarded with in the
specified time
5.
Number of serious or suspected serious AE reports not forwarded with in
the specified time along with the reasons for delay
6.
Important happenings or development (events that happened other than
the way they should have happened or the events that did not happen other than
the way they should have happened)
7.
Total number of AEs forms received
8.
Number of recommendations from Regional Pharmacovigilance centres for
new peripheral pharmacovigilance centre
9.
Number of forms archived
10.
Monitoring activities done
11.
No. of notifications / reports received from each centre
12.
No. of reports filled in inappropriately by respective Peripheral
Centre
13.
Actions taken / recommended
14.
Acknowledgements sent in time
15.
CME awareness activities if any
16.
Any other observations