Bhavdiya

Institute of Pharmaceutical Sciences and Research

Ayodhya (U.P.)

A Project Report
On

The recent development and future of Pharmacovigilance

Programme of India
Submitted to
Dr.APJ Abdul Kalam Technical University, Lucknow
For The Partial Fulfillment of the Requirement for Degree
Of
Bachelor of Pharmacy
2021-2022

Under the Supervision of

Mr. Ran Vijay Singh
Associate Professor/HOD
Affiliated to

DR. A.P.J Abdul Kalam Technical University, Lucknow (U.P.)

Submitted By

Nida Parveen
B.Pharm Final Year
Roll No- 1885150049
 A
Project Report on

The recent development and future prospects of

Pharmacovigilance Programme of India

By: Nida Parveen

University Roll No.:1885150049

Project submitted to DR. A.P.J Abdul Kalam Technical University,

Lucknow For the partial fulfillment of the award of degree of

Bachelor of Pharmacy

Under the guidance of

Mr. Ran Vijay Singh

(Head of Department)

FACULTY OF PHARMACY
BHAVDIYA INSTITUTE OF PHARMACEUTICAL SCIENCES
&
RESEARCH SEWAR SOHAWAL AYODHYA
 CERTIFICATE

This to certify that Nida Parveen has carried out project work present
in this project entitled “The recent development and future prospects
of Pharmacovigilance Programme of India” for the award of Degree
of Bachelor of Pharmacy from Dr. A. P. J. Abdul Kalam Technical
University, Lucknow under my supervision. The project report
embodies result of original work and studies carried out by the
student herself and content of the project report do not from the
basic for the award of any other degree to the candidate.

Supervisor
Mr. Ran Vijay Singh
Associate Professor/HOD
 CERTIFICATE

This is to certify that the work embodied in this project entitle “The

recent development and future prospects of Pharmacovigilance

Programme of India” has been carried out by Miss. Nida Parveen

under supervision of Mr. Ran Vijay Singh (Associate

Professor/HOD). He has fulfilled all the requirements of Dr. A. P. J.

Abdul Kalam Technical University, Lucknow, regarding the nature

of work for the award of Bachelor Degree. The work included in this

project, unless otherwise stated, is all original and the data presented

in this volume are based on author’s observations.

Date: - Director
Dr. Sanjay Kushwaha
 DECLARATION CERTIFICATE

This is certify that I, Nida Parveen has carried out the project work
presented in the project report entitled “The recent development
and future Prospect of Pharmacovigilance Programme of India ”
submitted to Dr. A. P. J Abdul Kalam Technical University
Lucknow in the partial fulfillment of the requirement for the degree
of B. Pharm is an authentic record of project done by me during the
B. Pharma. The supervision of Mr. Ran Vijay Singh (Associate
Professor/HOD) at Bhavdiya Institute of Pharmaceutical Sciences
& Research. It is also declared that the present report in part or full
has not been submitted to this University or any other
university/institute for the award of degree to candidates.

Date: Nida Parveen

Place: B.Pharm Final Year
 ACKNOWLEDGEMENT

It is matter to great rejoice to prepare a project “The recent development and future
prospects of Pharmacovigilance Programme of India”. This project was made as per Dr.
A.P.J Abdul Kalam Technical University syllabus. The detection of adverse drug reaction
and toxicity of the drug and safety of the drug keeping this fact in mind.
I wish to express my sincere and special thanks to May God with who bless, I completed my
project.
It makes me privilege to do work under inspiring guidance Mr. Ran Vijay Singh (HOD
BIPSR) is knowledge obviously provided to get moving focus that enables my vigor &
ability to complete my project. I am highly grateful to him for his kind & valuable guidance,
supervision, inspiration, co-operation & for providing required suggestions.
I express my sincere thanks to Dr. Sanjay Kushwaha (Director BIPSR), Mr. Prem Prasad
Kushwaha (Associate Prof.), Mr. Vipul Singh (Associate Prof.), Mrs. Jyoti Verma
(Associate Prof.), Miss. Pooja Kumari (Assistant Prof.), Mr. Jagdeesh Prasad, (Assistant
Prof.), Ms. Jyoti Vaish (Lecturer), Ms. Anupam Pandey (Lecturer), Mr. Rakesh K.
Pandey (Lecturer), Bhavdiya Institute of Pharmaceutical Sciences and Research for their
timely advice and cooperation.
I wish to express my sincere thanks to store incharge Mr. Anuj Singh lab technician Mr.
Dileep Verma, who help me to provide the chemical that help me to complete my project.
I also thank my friends Miss. Amreen Bano, Miss. Saumya Dwivedi, Miss. Afreen Naaz,
for providing support and friendship that I needed.
I would like also acknowledgement to my parents Mr. Parvez Ahmad, Mrs. Taiseem
Bano, and my family member Suheb Ahmad, Naziya Bano & Humaira who help me
directly & indirectly to complete this project.
Thanking again
Nida Parveen
B.Pharm Final Year
Roll No- 1885150049
 Content

SR.NO TITLE PAGE NO

1 Abstract 1
2 Introduction 2-3
3 Establishing Culture of 3-4
Adverse Drug Reaction
Reporting
4 Completeness Score for 5
Indian Individual Case Safety
Reports
5 Coordination of Indian 6-7
Pharmacopoeia Commission
with other organizations
6 Integration of 8
Pharmacovigilance
Programme of India and
Revised National
Tuberculosis Control
Programme
7 Collaboration with Adverse 9
Events Following
Immunization
8 Collaboration with Central 9-10
Drugs Standard Control
Organization
9 Material & Method 10-14
10 Result and Discussion 15
11 Conclusion 16
12 Reference 17