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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 Zonal Pharmacovigilance centre (covering *
regions)
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
Zonal
centres will be the tertiary 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 zonal 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.
Zonal
Centre is expected to carry out the following tasks:
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S.
No.
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Task
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1.
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The
coordinator designated by CDSCO for the Zonal Centre for the
program would ensure conformity of his functioning with the
protocols of National Pharmacovigilance program.
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2.
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Interact
with regional centres allocated to the zone, provide them
with technical
support, coordinate and monitor their functions
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3.
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Collect,
collate and computerize the data reported by the regional
institutions and by its own center.
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4.
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Monitor
quality of data reported by regional and peripheral centres
by carrying out technical audits to ensure compliance, take
corrective measures and ensure implementation of corrective
measures.
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5.
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Carry
out (and/or review) data causality analysis of all ADEs
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6.
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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.
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7.
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Carryout
special projects on drug safety at the request of the CDSCO.
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8.
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Wider
dissemination of information on ADE including technical
support for ADE monitoring to institutions outside the
National Pharmacovigilance Program.
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9.
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Receive
funds from CDSCO
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10.
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Maintain
the accounts as per the project requirements and as per your
institution’s systems; to review the account statements
received from regional centers and submission of audited
statement of accounts within 3 months of completion of the
financial year to National Centre at CDSCO H.Q.
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11.
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To
receive blank ADE forms form National Pharmacovigilance
Centre and acknowledge the receipt
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12.
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To
maintain log of all ADE forms and ADE notification forms
received and forwarded
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13.
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To
fill or get filled minimum 100 ADE forms from their own
center.
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14.
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Collect
& collate Adverse Drug notifications from Regional as
well as own centers [those generated at the same centre and
those received from immediate lower-level centre] and forward
all duly-filled ADE forms as well as periodic reports to
National Pharmacovigilance Centre at CDSCO H.Q.
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15.
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Organize
training programmes / interactive meetings for all regional
and peripheral centres falling under the respective zonal
pharmacovigilance centers and attend other such meetings
organized under the program
by CDSCO.
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16.
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To
provide updates, reports and such other information as may be
required by the National Pharmacovigilance Advisory Committee
and to attend their meetings.
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17.
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To
conduct special pharmacovigilance projects on various drugs
which may be of special concern or interest to CDSCO /
Government of India
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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:
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S.
No.
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Task
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Time
Schedule
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1.
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The
coordinator designated by CDSCO for the Zonal Centre for the
program would ensure conformity of his functioning with the
protocols of National Pharmacovigilance program.
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One
month from the date of appointment.
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Interact
with regional centres allocated to the zone, provide them
with general technical support, coordinate and monitor their
functions
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One
month from the date of appointment.
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3
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Collect,
collate and computerize the data reported by the regional
institutions and by its own center
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Monthly
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4
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Monitor
quality of data reported by regional and peripheral centres
by carrying out technical audits to ensure compliance, take
corrective measures and monitor the implementation for
corrective measures
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Quarterly
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5
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Carry
out (and/or review) data causality analysis of all ADEs
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Monthly
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6
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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.
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Ongoing
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7
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Carryout
special projects on drug safety at the request of the CDSCO.
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Ongoing
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8
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Wider
dissemination of information on ADE including technical
support for ADE monitoring to institutions outside the
National Pharmacovigilance Program.
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Ongoing
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9
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Receive funds from CDSCO
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Ongoing
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10
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Maintain
the accounts as per the project requirements and as per your
institution’s systems; to review the account statements
received from regional centers and submission of audited
statement of accounts within 3 months of completion of the
financial year to National Centre at CDSCO H.Q.
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Ongoing
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11
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To
receive blank ADE forms form National Pharmacovigilance
Centre and acknowledge the receipt
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Ongoing
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12
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To
maintain log of all ADE forms and ADE notification forms
received and forwarded
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Ongoing
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13
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To
fill or get filled minimum 100 ADE forms from their own
center.
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Monthly
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14
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Collect
& collate Adverse Drug notifications from Regional as
well as own centers [those generated at the same centre and
those received from immediate lower-level centre] and forward
all duly-filled ADE forms as well as periodic reports to
National Pharmacovigilance Centre at CDSCO
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Monthly
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15
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Organize
training programmes / interactive meetings for all regional
and peripheral centres falling under the respective zonal
pharmacovigilance centers and attend other such meetings
organized under the program
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Six
months in addition to induction training
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16
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To
provide updates, reports and such other information as may be
required by the National Pharmacovigilance Advisory Committee
and to attend their meetings
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Ongoing
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17
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To
conduct special pharmacovigilance projects on various drugs
which may be of special concern or interest to CDSCO /
Government of India
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Ongoing
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5.
Data Services and Facilities to be provided by CDSCO
CDSCO
shall coordinate the programme and arrange for training for
those professionals who are participating in the programme.
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, Manpower and Facilities to be provided
by National Pharmacovigilance Centre at CDSCO H.Q.
The
following financial support and manpower shall be provided by
CDSCO:
1. One post of
Pharmacologist: Minimum qualification: M.Pharm, Desired
Qualification: M.Pharm. with pharmacology or clinical pharmacy.
Maximum remuneration of Rs. 15,000.00 (fixed) per month
2. One post of Computer
Operator/Data Manager: Graduate
in any discipline with at least one year computer diploma,
experienced in data handling and updation. Maximum remuneration
of Rs. 8,500.00 (fixed) per month
All
staff members shall be identified and retained by the zonal
centres on contract on year-to-year basis with the approval of
DCG(I).
3. Office Operation
Suport for Zonal center Rs.
25,000.00 p.a.
4. 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:
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Chairperson
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Director General Health Services
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Member Secretary
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DCG(I)
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1. ICMR
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D. G., ICMR, New Delhi
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2. AIIMS, New Delhi, Zonal
Centre
Coordinator
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Dr. S. K. Gupta, Head of the Department of Pharmacology, AIIMS, New
Delhi
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3. SGC Medical College,
Mumbai, Zonal Centre Coordinator
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Dr. Nilima Kshirsagar, SGS Medical College (Mumbai)
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4. Member, Pharmacology
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Dr. Ranjit Roy Choudhary, NII, New Delhi
Dr. C. Adithan, Prof. Pharmacology JIPMER, Pondicherry
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5. Forensic Medicine
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Dr. T. D. Dogra, (AIIMS, New Delhi)
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6. General Medicine
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Dr. A. K. Agarwal (RML, New Delhi)
Dr. Anoop Mishra (AIIMS, New Delhi)
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7. Clinical Pharmacology
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Dr. S. D. Seth, Chair-in Clinical Pharmacology (ICMR, New Delhi)
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8. Member, Pharmacy
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Mr. Brijesh Regal, WHO Consultant New Delhi
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9. Member, Toxicology
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Dr. Y. K. Gupta, Director, (ITRC, Lucknow)
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10. Member, Epidemiology
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Dr. M. D. Gupte (ICMR Institute of Epidemiology, Chennai)
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11. Member, Pathology
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Dr. Kusum Verma Member Secretary, (AIIMS Ethics Committee, New Delhi)
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12. Member, Drug Information
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Dr. Pramil Tiwari (NIPER, Mohali)
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13. Member, Phytotherapy
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Dr. Urmila Thatte, Head of the Department of Pharmacology, B. L. Nair
Medical College Hospital, Mumbai
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9.
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.
Total no.
of AE forms received from Regional Centre in which causality
assessments has been made
10.
Number of
AE forms received from Regional Centre in which causality
assessment has been verified / reassessed
11.
Number of
forms archived
12.
Monitoring
activities done
13.
No. of
notifications / reports received from each centre
14.
No. of
reports filled in inappropriately by respective Regional Centres
15.
Actions
taken / recommended
16.
Acknowledgements
sent in time
17.
CME
awareness activities if any
18.
Any other
observations
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