Terms of Reference for engagement of Regional 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 Regional 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 appropriateregulatory interventions

2.      To create awareness about ADR monitoring in India

 

Regional centres will be the secondary 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 regional 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.

 

 

Regional Centre is expected to carry out the following tasks:

 

 

S. No.

Task

  1.  

The coordinator designated by CDSCO for the Regional Centre for the program would ensure conformity of his functioning with the protocols of National Pharmacovigilance program.
  1.  

Correspond with Peripheral Centres, provide them with technical support, coordinate and monitor their functioning.
  1.  

Collect & collate Adverse Drug notifications from Peripheral as well as own centers [those generated at the same centre and those received from peripheral centres] and forward all duly-filled ADE forms to Zonal Centre

  1.  

Ensure quality of data reported by peripheral centres by carrying out technical audits to ensure compliance, take corrective measures and monitor the implementation for corrective measures.
  1.  

Organize and attend training programmes / interactive meetings for all peripheral centres falling under the respective regional pharmacovigilance centers

  1.  

Carryout special projects on drug safety at the request of the CDSCO.
  1.  

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.
  1.  

Carry out (and/or review) data causality analysis of all ADEs

  1.  

To receive blank ADE forms form Zonal or National Centre and acknowledge the receipt

  1.  

To maintain log of all ADE forms and ADE notification forms received and forwarded
  1.  

To fill or get filled minimum 50 ADE forms from their own center.
  1.  

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.
  1.  

Receive funds from CDSCO
  1.  

Maintain the accounts as per the project requirements and as per your institution’s systems; to review and consolidate the account statements of the peripheral centers and complied the statement of account of their own centre and ensure duly audited of statement of accounts to zonal center.

 

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 Regional Centre for the program would ensure conformity of his functioning with the protocols of National Pharmacovigilance program.

One month from date of appointment

2.

Correspond with Peripheral Centres, provide them with general technical support, coordinate and monitor their functioning.

One month from date of appointment

3.

Collect & collate Adverse Drug notifications from Peripheral as well as own centers [those generated at the same centre and those received from peripheral centres] and forward all duly-filled ADE forms to Zonal Centre

Monthly

4.

Monitor quality of data reported by peripheral centres by carrying out technical audits to ensure compliance, take corrective measures and monitor the implementation for corrective measures.

Quarterly

5.

Organize and attend training programmes / interactive meetings for all peripheral centres falling under the respective regional pharmacovigilance centers

Six months in addition to induction training.

6.

Carryout special projects on drug safety at the request of the CDSCO.

Ongoing

7.

To provide updates, reports and such other information as may be required by the National Pharmacovigilance Advisory Committee and to attend their meetings when called

Ongoing

8.

Carry out (and/or review) data causality analysis of all ADEs

Monthly

9.

To receive blank ADE forms form Zonal or National Centre and acknowledge the receipt

Ongoing

10.

To maintain log of all ADE forms and ADE notification forms received and forwarded

Ongoing

11.

To fill or get filled minimum 50 ADE forms from their own center.

Monthly

12.

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

13.

Receive funds from CDSCO

Ongoing

14.

Maintain the accounts as per the project requirements and as per your institution’s systems; to review and consolidate the account statements of the peripheral centers and complied the statement of account of their own centre and ensure duly audited of statement of accounts to zonal center.

Quarterly

 

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

 

The personnel for above post shall be identified and retained by the Regional centres on contract on year-to-year basis with the approval of DCG(I).

 

2.Office Operation Suport for Zonal center Rs. 25,000.00 p.a.

 

3.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 Regional Centre to Zonal Centre

 

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 Peripheral Pharmacovigilance centres for new peripheral pharmacovigilance centre

9.                  Total no. of AE forms received from Peripheral Centre in which causality assessments has been made

10.             Number of AE forms received from Peripheral 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 Peripheral Centres

15.             Actions taken / recommended

16.             Acknowledgements sent in time

17.             CME awareness activities if any

18.             Any other observations