Pharmacovigilance Programme of 

India (PvPI)

for

 Assuring Drug Safety

Central Drugs Standard Control Organization,

Directorate General of Health Services, Ministry of Health & Family Welfare

Government of India

in collaboration with  

Indian Pharmacopoeia Commission, Ghaziabad, U.P.

Contents
1. Introduction
2. Pharmacovigilance Programme of India
3. Steering Committee
4. Goals and Objectives
5. Governance Structure
6. Programme Roadmap
7. Targets
8. Collaboration with World Health Organization and The Uppsala Monitoring Centre (WHO-UMC)
9. Programme Systems and Procedures
10. Operational Aspects
11. Functions of the Stakeholders in the Programme
12. Safety Database
13. Risk Management
14. Programme Communications
15. Monitoring Evaluation

1.                1. Introduction  

The Pharmaceutical industry in India is valued at Rs. 90,000 Crore and is growing at the rate of 12 – 14 % per annum. Exports are growing at 25 % Compound Annual Growth Rate (CAGR) every year. The total export of Pharma products is to the extent of Rs. 40,000 Crore. India is now being recognized as the ‘Global pharmacy of Generic Drugs’ & has distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub of Global Clinical trials & a destination for Drug Discovery & Development.

Further, more & more  new drugs are being introduced into the country which include New Chemical Entities (NCE), high tech pharma products, vaccines  as well as new dosage forms, new routes of drug administrations and new therapeutic claims of existing drugs. This is reflected in the fact that total number of applications received & processed have more than doubled from around 10,000 in the Year 2005 to 22,806 in Year 2009 at CDSCO, HQ, New Delhi. This includes increase in New Drug Applications, Global Clinical Trials, Market Authorization of Vaccine & Biotech products from 1200 ,100 ,10 in Year 2005 to 1753, 262 & 137 in the Year 2009 respectively. 

 Such rapid induction of NCEs and High tech Pharma products in the market throw up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base.All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any new information available in relation to their safety profile. In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programme for the nation.  Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines is the rationale to institute this program for India.

Since, there are considerable social and economic consequences of ADRs there is a need to engage health-care professionals, in a well structured programme to build synergies for monitoring ADRs. The purpose of the Pharmacovigilance Program of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public

2.            Pharmacovigilance Programme of India (PvPI)

 The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia commission, Ghaziabad is initiating a nation-wide Pharmacovigilance programme for protecting the health of the patients by assuring drug safety. The programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will operate under the supervision of a Steering Committee.

  3.            Steering Committee

 4.             Goal and Objectives

4.1       Goal

To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the Indian population.

 4.2       Objectives 

                 ·         To monitor Adverse Drug Reactions (ADRs) in Indian population

·         To create awareness amongst health care professionals about the importance of  ADR reporting in India

·         To monitor benefit-risk profile of medicines

·         Generate independent, evidence based recommendations on the safety of medicines

·         Support the CDSCO for formulating safety related regulatory decisions for medicines

·         Communicate findings with all key stakeholders

·         Create a national centre of excellence at par with global drug safety monitoring standards

 4.3       Programme governance and reporting structures

 The Pharmacovigilance Programme of India will be administered and monitored by the following two committees.  

                      I.        Steering Committee

                    II.        Strategic Advisory Committee  

Technical support will be provided by the following committees:

                      I.        Signal Review Panel

                    II.        Core Training Panel

                   III.        Quality Review Panel

5.         Governance Structure  

ADR MONITORING CENTRES

6. Programme Roadmap (June 2010- March 2015)

7.         Targets

The targets for each of these five phases are listed below:

8.         Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC)

 WHO and UMC work with and/or provide technical support to more than 94 countries worldwide. The long term objective of the PvPI is to establish a ‘Centre of Excellence’ for Pharmacovigilance in India.  To achieve this objective, the PvPI National Coordinating Centre will collaborate with the WHO Collaborating Centre - Uppsala Monitoring Centre (UMC) based in Sweden.

• Training of the staff at the PvPI national coordinating centre at IPC Ghaziabad, the ADR Monitoring centers in medical colleges across the country

•      Usage of UMC’s Vigiflow software (for medicines) and Paniflow (for vaccines) at no cost to PvPI. 

•       Access to Vigibase, which contains worldwide medicines safety data

•  Access to early information about potential safety hazards of medicines (worldwide data)

•  Technical collaboration for Pharmacovigilance Programme of India

•  Technical collaboration for a regular publication that will be issued by the PvPI National Coordinating Centre for distribution to the ADR Monitoring centers and other stakeholders.

CDSCO Headquarters has held several meetings with UMC over the past few years to discuss the potential role and approach for technical collaboration. 

9.         Programme Systems and Procedures

 Selection of ADR Monitoring centers

 A.  Medical Colleges - A ‘Letter of Intent’ will be invited from the Head of Pharmacology, duly forwarded by the Principal/Director/Head of each of the participating medical colleges. In the FY 2010-11, 40 ADR monitoring centers will be enrolled. An additional 60 centers will be enrolled in the FY 2011-12 and an incremental addition of 100 each respectively for FY 2012-13 and 2013-14 will be done, resulting in 300 enrolled centers.   

The Pharmacovigilance Centers in each Medical college enrolled under the project will be provided technical, administrative, & financial support by the respective Zonal /Sub Zonal Offices of CDSCO under whose jurisdiction the respective medical Colleges fall.

   B.    Medical institutes/central institutes/autonomous institutes like ICMR will also be inducted into the programme as AMCs on voluntary basis, and will not be provided any support from CDSCO.

 C.   Public and corporate hospitals will be inducted on a voluntary basis, and will not be provided any support from CDSCO.

10.       Operational Aspects

Appropriate systems and procedures will be instituted to ensure that uniform processes are followed. These processes will largely cover the following aspects:

      I.        Roles and responsibilities of different personnel in PvPI

    II.        Training of programme personnel (including post training assessments & certifications)

   III.        Centre management (including infrastructure, manpower, status reports)

  IV.        Processing and reporting of suspected adverse drug reactions

    V.        Compliance and quality assurance in the programme

  VI.        Regulatory decision making

 VII.        Communication amongst various stakeholders

Continuous monitoring of the above mentioned processes will be done and appropriate revisions undertaken by the Pharmacovigilance Center at CDSCO, HQ.  

11.       Functions of the stakeholders in the Programme

12.       Safety Database  

Vigiflow software provided by WHO-Uppsala Monitoring Centre will be utilized as the safety database, where all data originating from India will be maintained in a secure and confidential manner.

13.       Risk Management

 13.1     Ensure availability and management of funds:

 The contingency fund and salary of the technical associates appointed at the ADR monitoring centre should reach in time. This will be coordinated by CDSCO headquarters through its Zonal and Sub-zonal offices.  

13.2     Conduct frequent training and awareness of Pharmacovigilance:  

ADR Monitoring Centers (AMCs) coordinator must organize at least two meetings with  in their areas. Expenses should be met from the contingency fund. Coordinator should be the resource person for such meetings.  

13.3     Detect and respond to under reporting of Adverse Drug Reactions:  

Periodic sensitization of Health Care Professionals through various modes viz posters, pamphlets, SMSes, etc. by the center coordinator will improve AE reporting.  

13.4     Ensure quality of filled ADR forms:  

The Quality Review Panel will ensure quality of reports during their visit to AMC and also at the PvPI National Coordinating Centre (NCC).  

13.5     Proper supervision of functioning of the centers:  

A Quality Review Panel shall visit a sample set of AMCs as defined in the SOP, at least once a year to monitor functioning of these centers.  If functioning of the Centre is found unsatisfactory or not working as per SOPs, an appropriate warning shall be issued. In case there is a training requirement the same will be imparted. The report should decide the status of the centre. If performing well, the AMC shall be given due recognition for its achievements.  

13.6     Feed back to the Health Care Professionals:

 AMC coordinator will circulate the reports generated by the PvPI National Coordinating Centre and give feedback of the programme progress to the Health Care Professionals.  

14.       Programme Communications

 Effective communication channels are the key to a successful PvPI. The following chart depicts the movement of information between the key stakeholders and ensures the continuous bidirectional nature of the transfer of data, information, and knowledge

Communication Channel Descriptors      Program Communications ADR Reporting Administrative Reporting Interaction with professional bodies from Medical Professionals, Industry etc

15.       Monitoring & Evaluation:

To ensure the PvPI operates effectively and achieves its objectives, the centre will establish key indicators to measure the efficiency of (i) process (ii) outcome and (iii) impact of the PvPI.  

i.      Process Indicators:

The following indicators will be measured:

a.    Number of ADR monitoring centers participating in the PvPI

b.    Number of AMC personnel trained in a year

c.    Funds budgeted for PvPI and funds spent

d.    AMC Personnel working full-time for PvPI

ii.     Outcome Indicators:

a.    Software platform established

b.    Number of ADR reports received in a year

c.    Number of ADR reports processed in a year

d.    Number of ADR reports submitted to Vigiflow

iii.     Impact Indicators:

a.    Number of signals generated and confirmed

b.    Number of safety related alerts issued by CDSCO