Terms of Reference for engagement of Zonal 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 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:

S. No.	Task
1.	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.
2.	Interact with regional centres allocated to the zone, provide them with technical support, coordinate and monitor their functions
3.	Collect, collate and computerize the data reported by the regional institutions and by its own center.
4.	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.
5.	Carry out (and/or review) data causality analysis of all ADEs
6.	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.
7.	Carryout special projects on drug safety at the request of the CDSCO.
8.	Wider dissemination of information on ADE including technical support for ADE monitoring to institutions outside the National Pharmacovigilance Program.
9.	Receive funds from CDSCO
10.	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.
11.	To receive blank ADE forms form National Pharmacovigilance Centre and acknowledge the receipt
12.	To maintain log of all ADE forms and ADE notification forms received and forwarded
13.	To fill or get filled minimum 100 ADE forms from their own center.
14.	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.
15.	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.
16.	To provide updates, reports and such other information as may be required by the National Pharmacovigilance Advisory Committee and to attend their meetings.
17.	To conduct special pharmacovigilance projects on various drugs which may be of special concern or interest to CDSCO / Government of India

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 Zonal Centre for the program would ensure conformity of his functioning with the protocols of National Pharmacovigilance program.	One month from the date of appointment.
2	Interact with regional centres allocated to the zone, provide them with general technical support, coordinate and monitor their functions	One month from the date of appointment.
3	Collect, collate and computerize the data reported by the regional institutions and by its own center	Monthly
4	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	Quarterly
5	Carry out (and/or review) data causality analysis of all ADEs	Monthly
6	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
7	Carryout special projects on drug safety at the request of the CDSCO.	Ongoing
8	Wider dissemination of information on ADE including technical support for ADE monitoring to institutions outside the National Pharmacovigilance Program.	Ongoing
9	Receive funds from CDSCO	Ongoing
10	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.	Ongoing
11	To receive blank ADE forms form National Pharmacovigilance Centre and acknowledge the receipt	Ongoing
12	To maintain log of all ADE forms and ADE notification forms received and forwarded	Ongoing
13	To fill or get filled minimum 100 ADE forms from their own center.	Monthly
14	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	Monthly
15	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	Six months in addition to induction training
16	To provide updates, reports and such other information as may be required by the National Pharmacovigilance Advisory Committee and to attend their meetings	Ongoing
17	To conduct special pharmacovigilance projects on various drugs which may be of special concern or interest to CDSCO / Government of India	Ongoing

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:

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

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