Medyur Pharmaceuticals Limited

BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL

GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

1.1 Detailed description of Pharmacovigilance and Risk Management System

S
Pharmacovigilance System

At present we have the manual system for compilation of safety information, risk identification and reports
generation. Our risk minimization plan includes use of following tools for providing additional educational
material about the medicine and its use through-
through

Patient Information Brochures

Physician prescribing material-updated
material based
ed on risk identification
Package insert-Periodically
Periodically updated based on the risk identification.

The process of Pharmacovigilance procedure starting from data collection till final reports generation is
depicted in the following chart.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

THE ORGANIZATIONAL DIAGRAM PHARMACOVIGILANCE THE HOLDER OF THE

REGISTRATION CERTIFICATE

Doctors Pharmacists Institutions Patients Patients

 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

1. The description of the organization’s internal Pharmacovigilance department

Organization

Medyur Pharmaceuticals Limited, India

Address:

14 Milestone, Rudrapur-Kashipur
Rudrapur Road,

Gadarpur, U.S.Nagar-263152,
U.S.Nagar Uttarakhand-India.

2. Pharmacovigilance head:
This person is Qualified Person Responsible for Pharmacovigilance, responsible for all kind of studies,
surveys and collecting data and then access properly to give positive results. This person supervises all
the data and their responses.

3. Pharmacovigilance
Pharmacovi Senior Executives:

These persons supervise all the kind of studies, surveys, accessing of all signals and properly respond to
the signals.

4. Pharmacovigilance Executives:

These persons guide Marketing team so that they can effectively collect and give responses to the
information or signals from market. These persons sometimes go in the market alone or with marketing
team members whenever it is required.

They move into the actual market (i.e. to the institutions, doctors, consumer of the drugs and pharmacist)
for collecting data on the response of the drug. After collecting data from market they send these to the
office where this data is studied by their seniors for further actions.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

2. A document confirming presence of QPPV on the territory of RK

RK flow of information of
adverse reaction towards Pharmacovigilance department
The flow of reception of adverse reaction:
1. Information regarding adverse effects is collected from Doctors, Pharmacist, Patients, Institutions
and the new researches
2. After analysis
alysis of received information from sources like doctors, pharmacists, institutions &
Patients improved reports are prepared by executives of Pharmacovigilance department and these reports
then transferred to Senior Pharmacovigilance Executives.
3. Re-analysis
ysis of the generated data is performed by Senior Pharmacovigilance Executives and
finally submittedto Pharmacovigilance head i.e. QPPA (Qualified Person for Pharmacovigilance).
4. The QPPA finally analyze and if require, prepare the report for submission to regional and/or
Zonal Pharmacovigilance authorities.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

FLOW OF INFORMATION

Regional and/or Zonal Authorities

Pharmacovigilance QA
Head

Senior Senior
Pharmacovigilance Pharmacovigilance
Executive Executive

Marketing Team Pharmacovigilance Marketing Team Pharmacovigilance

Executive Executive

Doctors Pharmacists Institutions Patients New Clinical trials,

publications &
researches
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

a. RECEPTION OF MESSAGES
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

ADVICE ABOUT REPORTING

Report adverse experiences with medications

Report serious adverse reactions: A reaction is serious when the outcome is:
Death
Life
Life-threatening (real risk of dying)
Hospitalization (initial or prolonged)
Disability (significant, persistent or permanent)
Congenital anomalies
Required intervention to prevent permanent impairment or damage

1. Report even if:

You’re not certain the product caused adverse reaction
You don’t have all the details although point nos. 1, 5, 7, 8, 11, 15, 16 & 18 are essentially required.

2. Report can be given by:

Any health care professional (Doctors includingDentists, Nurses and Pharmacists).

3. Person should Report to:

After completing, please return this form to the same Pharmacovigilance Centre whose address is
mention on the form.

4. What happens to the submitted information:

Information provided in this form is handled in strict confidence. After accessing, if Pharmacovigilance
department found new and remarkable adverse reactions then the Company’s Pharmacovigilance
Pharmacov Centre
will forward this information to the Peripheral and then Regional Pharmacovigilance Centers, where the
causality analysis is carried out.
Data is periodically reviewed by the National Pharmacovigilance Advisory Committee. The Committee
is entrusted
ntrusted with responsibility to review the data and suggest any interventions that may be required.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

3. REVEALING OF SIGNALS
The information obtained from report will be used to promote safe use of medicines in the local, national
natio
and international levels. The report will be entered into the national database of adverse drug reactions and
be analyzed by expert reviewers on a regular basis.
A well - completed and duly submitted ADR reported may result in:
Appropriate changes in the package insert.
Change the
th schedule of the medicine.
Enhancing educational initiatives to improve the safe use of that Medicine.
Other regulatory and health promotion interventions as the situation may warrant including withdrawal /
recall. Other promotional strategies that may be considered include:
Posters.
Leaflets for patients / doctors.
Pharmacovigilance--related
related articles in the newspapers/health journals.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

4. PROCEDURE OF DOCUMENTING

Regional and/or Zonal Authorities

The QPPA finally analyze and if require, prepare the report for submission to regional
and/or Zonal Pharmacovigilance authorities.

Pharmacovigilance QA
Head

Reanalysis of the generated data and final submission to Pharmacovigilance head i.e.
QPPA (Qualified Person for Pharmacovigilance).

Senior Senior
Pharmacovigilance Pharmacovigilance
Executive Executive

• After analysis of received information from sources like doctors, pharmacists, institutions &
Patients an improved reports with the data as per product, batch number of product, area
type of patients, type of dosage schedule, type of route of administration, type of overdosage,
type of age group of patients, type of sex of patients, period of treatment
treatment & type of severity of
adverse reactions are prepared and these reports then transferred to Senior
Pharmacovigilance Executives.
• Analysis of Adverse reactions whether they are newly identified or already discussed during
the launching of product in publications, literatures, product manuals, product inserts & other
product informative documents.
• If found any particular batch of the product is responsible for described adverse reactions then
make arrangements for the quality control analysis of aforesaid
afores batch number.

Information regarding adverse effects are collected as per pre – approved format.

Doctors
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

5. A DATABASE FOR PHARMACOVIGILANCE

Main database used for Pharmacovigilance purposes (e.g. compilation of safety reports, expedited/electronic
reporting, signal detection, sharing and accessing global safety information) are provided with a statement
regarding the validation status of the database systems.
A statement is regarding the compliance of the systems with the
the internationally agreed standards for
electronic submission of adverse reaction reports.
Database is also used to identify potential signals and analyze data in order to clarify the risk factors and
apparent changes in reporting profiles.
Database functionally
onally enables us to search and retrieve data to facilitate cumulative data review, signal
detection and trend analysis.

1. TRAINING OF EMPLOYEES
To ensure harmonized implementation of the Programmed efforts at a uniform understanding of the
operational systems,
ms, along with standardized formats to document and analyze ADRs. An induction training
program is arranged for all persons after joining the division.
Intensive interaction / training sessions is organized for not only staff within the Pharmacovigilance units
u
but also staff who may receive or process safety reports, such as sales personnel or clinical research staff to:
2. CLEARLY DEFINE THEIR INDIVIDUAL AND TEAM ROLES AND RESPONSIBILITIES
ii. Set operational benchmarks e.g.
1. Each Pharmacovigilance Executive
a. to collate and scrutinize the data received
b. to perform the analysis of all forms received every month.
c. to submit a monthly report.
d. to report any alarming or critical ADR along with supportingevidence

2. Each Senior Pharmacovigilance

Pharmacovigila Executive
a. to collate the data received from Pharmacovigilance Executive.
b. to verify / validate the analysis.
c. to pass on the final data to QPPV.

iii. Evolve SOPs for generating and forwarding ADR data.

 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

iv. Impart relevant skills for carrying out ADR data capture namely.

1. Appropriate communication skills to elicit ADR related information

2. For recording ADR information through hands-on

hands on training

3. For careful collation and completeness of data

These training programs and interaction meetings
meetings are used to be held every 6 months after the initial
training.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

7. THE LIST OF DOCUMENTS OF PHARMACOVIGILANCE

Different types of documents used in the Pharmacovigilance department are as follows:

1. Suspected Adverse Drug Reaction Reporting Form

2. Expedited Report
3. Electronic Report
4. Periodic Safety Update Reports (PSURs)
5. Risk Management Assessment
6. Internal Audit Reports
7. Training Manuals

8. A CONTROL SYSTEM OF QUALITY PHARMACOVIGILANCE

For the Quality Management, Pharmacovigilance department or authorized Persons perform their activities
as per described responsibilities and these responsibilities are audited time to time.
Quality management of Pharmacovigilance is generally based on:-
on:

• Acquiring complete data from adverse effects generation points.

point

• Complete assessment of acquired data of adverse effects.

• Transfer of necessary information to higher authorities of Pharmacovigilance department in the

favor of safety of particular medicines.

• To fulfill the responsibility to make aware with found adverse effects to all related medical
professionals and to give corrective & preventive actions.

• To take required safety measures and Call-back

Call back products which are already in market, if found
serious adverse event or guided by higher authorities.

• Preparation
ion and submission of adverse events reports and related documents like PSURs, Risk
Management systems etc. to the regional and zonal Pharmacovigilance Authorities for further study and
analyses.
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

Approved By:

Dr. N K Nagrani
Head, Pharmaco-vigilance

Medyur Pharmaceuticals Limited, India.

India
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL

Document confirming presence of qualified person responsible for pharmacovigilance for

collection and registration of adverse reactions detection on the territory of Republic of Uzbekistan
===Attached Herewith===
 Medyur Pharmaceuticals Limited
BRAND NAME: CITICOLINE SODIUM ORAL DROPS 100 mg/mL
GENERIC NAME: Citicoline Sodium Oral Drops 100 mg/mL
NAME : Dr. N K Nagrani
PERSONAL DETAILS:
Name : N K Nagrani
Date of birth : March 12, 1960
Place of birth : Lucknow, India
Nationality : Indian
Address :
14 Milestone, Rudrapur-Kashipur Road,

Gadarpur, U.S.Nagar-263152, Uttarakhand-India.

India.

PROFESSIONAL EXPERIENCE
Working as::
Head of Department (CLINICAL AND
Aug. 2002 Onwards BIOLOGICAL)in
Medyur Pharmaceuticals Limited, India.
India
Engaged in private practice in own clinic as
Jan 98 – July 2002 Consultant Physician.

MEDICAL EDUCATION & TRAINING

Sept. 96 – Aug. 98
Certification, Clinical Research (CRA), INDIA
Internship and Residency in Medicine,
DelhiUniversity, Delhi, India
Nov. 93 – Oct.95

MD physician,
Sept. 91 – Oct. 93 Era’s Medical College
Lucknow, UP
Medical Degree MBBS,
July 85 – May 91 Era’s Medical College
Lucknow, UP