PHARMACOVIGILANCE IN INDIA : AN INSIGHT

Presented by Dr. Pratistha SinghClinical Research Fellow student , AAPS, Toronto, Canada2015-2016

Clinical Research and Pharmacovigilance Program DirectorProf. Peivand Pirouzi

TABLE OF CONTENTS

Introduction

Clinical Trials in India

Pharmacovigilance in India

The Challenges Of Pharmacovigilance In India

Conclusion

References

INTRODUCTION

Pharmacovigilance - the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

“Pharmacovigilance” - officially introduced in Dec 1961 by W. McBride , an Australian doctor.

The term PV - in the mid-70s by a French group of pharmacologists and toxicologists.

In 1968, the World Health Organization (WHO) promoted the “Program for International Drug Monitoring”, a pilot project aimed to centralize world data on adverse drug reactions (ADRs).

CLINICAL TRIALS IN INDIA

As per a recent report from Federation of Indian Chambers of Commerce and Industry (FICCI) :-

• scientific feasibility, • medical infrastructure, • competent workforce, • clinical trial experience, • regulations, • commercialization potential and • cost competitiveness

SWOT ANALYSIS OF INDIAN CLINICAL TRIAL SECTOR

Strengths• Large population of over 1.2 billion, about 16% of the

world’s population.• Huge pharmaceutical and biotech industry base with

availability of skilled persons.• Third largest players in the world with 500 different

active pharmaceutical ingredients.• Currently accounts for 8% of global pharmaceutical

production, being fourth in the world.• Conducive initiatives to harness India's innovation

capability by the government.• Huge data mining related to safety profile of drugs

possibilities due to large population.

Weaknesses• As per 2009-10 estimates, expenditure on health sector was

2.1% of the total budget and 0.35% of the Gross domestic product (GDP) of India while developed countries like United States, France, Switzerland and Germany, spent around 16%, 11%, 10.8% and 10.4% of their GDP respectively.

• Less funding available for implementation of programs and issues of national importance such as PV.

Opportunities• The Indian population is the largest source of human

biodiversity.

SWOT ANALYSIS

SWOT ANALYSIS

• Consists of 4635 culturally and anthropologically well-defined populations, representing a perfect model to study efficacy, disease susceptibility, etiology, molecular pathology, and safety profile of drugs with respect to genetic diversity.

• Excellent potential for skilled human resources required for an effective PV system due to >300 medical, >230 dental,> 830 pharmacy and >650 recognized nursing colleges in India .

Threats• Under reporting of ADRs.• Low availability of funds.• Less ADRs monitoring centers.

A G E N C I E S I N VO LV E D F O R C L I N I C A L R E S E A R C H R E G U L AT I O N I N I N D I A

Regulatory body in India – DCGI (Drug Controller General of India) which operates under Central Drug Standard Control Organisation (CDSCO)

Indian Council of Medical Research (ICMR) – Brought out the policy on ethical considerations involved in research on human subjects.

Central Bureau of Narcotics (CBN)

National Pharmacovigilance Advisory Committee (NPAC) - To collate, analyze and archive ADR data for creating healthy environment for the regulatory authorities to analyze the drug to be marketed in India.

PHARMACOVIGILANCE IN INDIA

Schedule Y of the Drugs and Cosmetics Act 1945 deals with the guidance related with

Legislative requirements of PV in India

regulations relating to pre-clinical and clinical studies for development of a new drug and

clinical trial requirements for import, manufacture, and obtaining marketing approval for a new drug in India

Schedule Y was revised and amended on 20 January 2005 as a continued commitment of the Drugs Controller General of India (DCGI) to ensure adequate compliance of PV obligations of pharmaceutical companies.

PHARMACOVIGILANCE PRO GRAM S IN INDIA

Up till now four programs have been launched in India.

1. 1986 – due to call of few physicians(academic institutions) for greater attention to the potential adverse effects of prescription medicines and rational prescribing of medicines, first ADR monitoring program was formulated which consisted 12 regional centers, each covering a population of 50 million, but was unsuccessful.

2. A decade later, India joined the WHO Adverse Drug Reaction Monitoring Program based in Uppsala, Sweden in 1997. 3 centers for ADR monitoring were identified.-AIIMS & 2 WHO special centers in Mumbai and Aligarh. These centers were to report ADRs to the drug regulatory authority of India. The major role of these centers was to monitor ADRs to medicines marketed in India.

This attempt was unsuccessful too as information about the need to report ADRs and about the functions of these monitoring centers never reached the prescribers and there was lack of funding from the government.

3. From 1 January 2005, the WHO-sponsored and World Bank-funded National Pharmacovigilance Program (NPVP) for India was formulated. The program had three broad objectives. The short-term objective was to foster a reporting culture, the intermediate objective was to involve large number of healthcare professionals in the system in information dissemination, and the long-term objective was for the program to be a benchmark for global drug monitoring. However, this program also failed.

PV PROGRAMS IN INDIA

4 . CURRENT PHARMACOVIGILANCE PROGRAM IN INDIA (PVPI )

In a brainstorming workshop jointly organized by AIIMS and CDSCO in late 2009, the framework of the new and current program was formulated.

On 14th July 2010 - The program, now rechristened as the Pharmacovigilance Program of India (PVPI) was initiated by the Government of India with the AIIMS, New Delhi as the National Coordination Centre (NCC) for monitoring ADRs in the country for safe-guarding public health.

In the year 2010 - 22 ADR monitoring centers including AIIMS, New Delhi was set up under this program.

On 15th April 2011 - To ensure implementation of this program in a more effective way, the NCC was shifted from the AIIMS, New Delhi to the Indian Pharmacopoeia Commission (IPC), Ghaziabad, UP.

The main aim of the NCC at IPC is to generate an independent data on the safety of medicines, which will be at par with global drug safety monitoring standards.

PVPI

The program was envisaged to be rolled out in three phases.:-

Phase I would include 40 ADR monitoring centers (AMC) to be rolled out in 2010.

Phase II - the program would be expanded in to include up to 140 MCI recognized medical colleges by 2011.

Phase III would ultimately cover the entire healthcare system by 2013.

The AMCs get operational and logistic support from the respective zonal CDSCO centers situated at Ghaziabad, Kolkata, Mumbai, and Chennai. The zonal CDSCO centers will be under administrative control of the CDSCO headquarters at New Delhi.

Following chart explains the flow of data at regional, national and international level:

HAEMOVIGILANCE PROGRAM

IPC, in collaboration with the National Institute of Biologicals (NIB) at Noida, launched Haemovigilance Program of India (HVPI) under PVPI.

It has two main objectives

1. To track adverse reactions/events and incidence associated with blood transfusion and blood product administration, and

2. To help identify trends, recommend best practices and interventions required to improve patient care and safety, while reducing overall cost of the healthcare system .

CURRENT STATUS OF PVPI

Iniitiated with 22 AMCs in the country, 150 AMCs have been established under this program and categorized into four zones i.e., North, South, East and West.

In the coming years, there will be 350 AMCs across the country. Under previous National Pharmacovigilance Program, 11633 ICSRs were reported from January 2006 to December 2008 whereas under PVPI, till June 2014, 78672 ICSRs were reported. Thus, it can be observed that the rate of reporting has been increased under PVPI.

In year 2013, India's contribution to WHO–UMC's global drug safety database (Vigibase) was 2%. India was 7th in position among top 10 counties contributing to global drug safety database.

Among Asian countries, India is the only country having about 1 lakhs ICSRs in Vigibase.

According to WHO-UMC Documentation Grading-Completeness Score, the average completeness score of India in 3rd quarter of 2014 was 0.94 out of 1. Thus, from this completeness score it can be predicted that AMCs of PVPI are collecting all the necessary information required for ADR reporting.

THE CHA LLE NGE S OF PHA RMA COVIGILA NCE IN INDIA

1) The biggest challenge facing the PVPI is the gross underreporting of adverse effects, which is due to lack of resources and inadequate nationwide awareness of PV,

2) Conservative infrastructure,

3) Wide time interval between guidelines and laws,

4) Orthodox attitude to new drug research, and

5) Regulatory inspections which are almost non-existent.

CONCLUSION

India now understands that the benefit-risk ratio of pharmaceutical products is a dynamic variable and that it has to be continuously monitored.

Indian pharmaceutical companies with international presence have understood the pharmacovigilance in the global scenario and are also starting to apply the same strategies in India too.

Signal detection and risk management have added new dimensions to the field of Indian pharmacovigilance and as evolving disciplines, they require ongoing refinement in order to increase their applicability and add value to the public health aspect in India.

PVPI is currently restricted to the govt. medical college hospitals, public health programs, and autonomous institutes like the Indian Council of Medical Research (ICMR).

The data received by PVPI is shared with the WHO but not shared with the concerned pharmaceutical companies.

REFERENCES

www.ipc.gov.in

www.ncb.nlm.nih.gov

www.chemtech-online.com