lMobile App for instant ADR

reporting to PvPI
lHealthcare professional can
access the tool on mobile
devices for reporting of ADRs
lOne touch access to
reporting ADRs in India

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

E d i t o r i a l Te a m

Mess a ge

from
Joint Secretary (Regulation), MoHFW

Dear Readers,
I am excited to reach you all
through this newsletter. I am
proud of the valued contributions
of some of the readers to PvPI.
Please accept my heartiest
congratulations!
The pharmacovigilance system
in India has evolved over the years through your
active cooperation. From establishment of ADR
monitoring system, reporting system, usage of data
communication and supporting Indian regulators for
making decision to protect patients safety, the Indian
Pharmacovigilance system has it all. My belief as
many of the readers would share, is that the scope
for improvement, active surveillance and innovation
in this programme is unprecedented. The system has
much more to offer than what we are currently able to
tap. I appeal to all healthcare providers to adopt the
culture of adverse events reporting and make it an
integral part of our process. I wish the stakeholders
and the employees of IPC, all the best to succeed in
their endeavours to achieve the milestones of patient
safety.
I hope you will enjoy reading this newsletter.

(K L Sharma)
Joint Secretary (Regulation)
Ministry of Health & Family Welfare
Government of India

Chief Editor
Dr. G. N. Singh
Secretary-cum-Scientific Director, IPC, Ghaziabad.
PvPI Advisor
Dr. S. K. Gupta
Emeritus Professor & HOD
Clinical Research, DIPSAR, New Delhi.
National Scientific Coordinator
Dr. Y. K. Gupta
Professor & HOD Pharmacology, AIIMS, New Delhi
Editor
Dr. V. Kalaiselvan
Principal Scientific Officer, IPC, Ghaziabad.
Associate Editor(s)
Dr. Mita Nandy
Consultant (New drugs), CDSCO, New Delhi.
Dr. Prasad Thota
Scientific Assistant, IPC, Ghaziabad.
Editorial Assistant(s)
Ms. Renuka Bhoi
Technical Associate, IPC, Ghaziabad.
Dr. Nagakishore Cheemakurthi
Technical Associate, IPC, Ghaziabad.

Advisory Board
Dr. C. Adithan
Senior Professor & Head, Dept. of Clinical Pharmacology,
JIPMER, Puducherry.
Dr. G. Parthasarathi
Dean Faculty of Pharmacy, Professor, Pharmacy Practice
JSS University, Mysore.
Mr. A.K. Pradhan
DDC, CDSCO (NZ), Ghaziabad
Dr. Bikash Medhi
Additional Professor, Dept. of Pharmacology,
PGIMER, Chandigarh.
Dr. Madhur Gupta
Technical Officer, WHO-Country Office (India).
Dr. Sushma Srivastava
Research Scientist, Delhi Institute of Pharmaceutical Sciences
and Research, New Delhi.
Mr. S. S. Venkatakrishnan
Former State Drugs Controller, Kerala.
Dr. Sabita Mohapatra
Professor & HOD, Dept. of Pharmacology,
VSS Medical College, Burla, Odisha.
Dr. Sachin Kuchya
Associate Professor, Dept. of Pharmacology,
NSCB Medical College, Jabalpur.
Dr. Dhriti K. Brahma
Associate Professor, Dept. of Pharmacology,
NEIGRIHMS, Shillong, Meghalaya.
Dr. Anuradha Joshi
Associate Professor, Dept. of Pharmacology,
PMCSKH, Anand, Gujarat.

Pharmacovigilantes
Qualities and Skills
P

harmacovigilantes (PVLs) are the

professionals engaged in detection,
assessment, understanding and prevention of adverse drug reactions (ADRs). The
PVLs are the specialized, extra committed
and dedicated professionals acting as
the main link between patients and other
healthcare providers for better outcome in
promoting safety of drugs.
The budding PVLs must have qualities
to set the highest professionals
standards and to bring the phase of
transformation in Pharmacovigilance
(PV). They must know the ethics and
good PV practices and should also
have the basic knowledge of concepts,
methodologies of PV, drug regulation
etc. so that they can be competent
enough to handling the issues like case
narrating and processing, causality
assessment, identifying new signals,
benefit risk assessment. They should
also be able to understand and device
strategies for risk management and
risk minimization plan. At the same
time, they must act in the interests of

the patients by applying their unique

skills and knowledge in drug therapy,
prescription etc which are well enough
to prevent adverse effects. PV is also
technology driven because information
technology (IT) is involved in all most
all sections ranging from data entry to
signal detection. Therefore, the PVLs
should be able to apply the IT tools
in their practice and also need to be
updated with the innovative newer
technologies to reach out the messages
in rapid and effective way.
PV is one of the profession which requires
utmost commitment and dedication
patients care delivery is involved.
Therefore there is no time limit for PVLs
to work in a day. They cannot stick to the
official working hours; they have to be
vigilant round the clock because ADRs to
the patients cannot be expected to occur
only during working hours. PV is the only
profession in healthcare to coordinate
with maximum number of stakeholders
such as pharmaceutical manufacturers,
doctors, pharmacists, nurses, patients,

regulators, media etc. Therefore, PVLs

should have command over management
and organizational skills. They should
also have capacity to guide colleagues
and lead the team. Since PV is a global
network and the activities cannot be
limited to one country; hence they also
required to be updated with the national
and international drug legislations, PV
affairs etc.
The purpose of PV is defeated if the
PVLs fails to communicate the findings
to the stakeholders on timely basis.
Therefore, they should be fluent in
English and Hindi too. It is justified
because around 41% population in
India speaks Hindi. If the PVLs are
posted in ADR monitoring centre of
non Hindi speaking states such as
Tamil Nadu, Karnataka, Kerala etc
they must have capacity to understand
local languages to communicate with
the patients. The PVLs should know
media ethics while communicating to
the Media. Usually the PVLs working
in the system are not supposed to

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

communicate the findings to the media

unless otherwise competent authority
is authorized to speak.

In addition to these, the PVLs should

have the following qualities to create the
excellence in PV:

Another important quality is they should

evoke a practice of sufficient and timely
feedback to the stakeholders, besides
redefining their expectations in order
to take them in to confidence in all PV
activities and also to seek their continuous
support.

a. Creating professional bonding with

the stakeholders
b. Maintaining the mutual relationship
with the colleagues and similarly
placed organizations (both national
and international)

c. Providing innovative ideas in PV

The PVLs should be proud of entering in
to the noble and wonderful profession
of PV and for being a partner of
patients care. The dynamic PVLs take
this opportunity seriously for their
career growth and also enhance their
respective organizations quality PV
business.

Important Events of PvPI

Mobile App for
ADRs Reporting
an Effective Tool:
Secretary Health

he current needs in pharmacovigilance

systems in developed countries have
almost reached the target because
healthcare professionals and marketing
authorization holders are well connected
with the system. Whereas, in developing
countries like India under reporting
of ADR remains serious concern. In
India IT is becoming a great facilitator
for promoting public health. India is
cementing its place IT sector through
mobile connections to reach every
individual in a population of 1.27 billion
where approximately 77.58% population
is already using mobile phones. Hence
it is more rationale to introduce the
concept of PvPI to stakeholders via

mobile phones. NCC-PvPI in technical

collaboration with NSCB Medical College,
Jabalpur developed a mobile application
for the healthcare professionals to
promote easy and instant reporting of
ADR. This facility was launched by Shri
B P Sharma, Secretary Health, Ministry
of Health & Family Welfare, Government
of India on 22nd May 2015 at Nirman
Bhawan, New Delhi. During the launch
Shri Sharma mentioned that this mobile
application is unique facility which will
bring strong network among healthcare
providers for promoting patients safety
in the country. He also expressed that
this application is poised to meet the
expectation of stakeholders specially
clinicians by saving the valuable time
in reporting ADR. He also reviewed the
progress of PvPI and appreciated the
employees of PvPI for their efforts.

Secretary & DG (CGHS), Dr. G N Singh

DCG(I) and other higher officials from
the ministry were also present on the
occasion.

Joint Secretary
Interacted with PvPI
Team to Focus on the
Future Action Plan

Padmashree Dr. Jagadish Prasad, DG,

DGHS, Shri K L Sharma, Joint Secretary,
Shri Navreet Singh Kang, Additional
Shri K L Sharma, JS(R) reviewing PvPI activities with Dr. G.N. Singh, DCG(I), Dr. Surinder
Singh, Director, NIB and IPC officials

Shri. B P Sharma, Secretary Health and higher officials of MoHFW, Govt. of India during the meeting
to review the progress of PvPI and launching the Mobile Apps for ADR reporting held on 22nd May
2015 at Nirman Bhawan, New Delhi

Shri K L Sharma, Joint Secretary

(Regulation), MoHFW, Government of
India, visited IPC on 4th June 2015 to
address the induction training for the
Assistant Drugs Controller (ADC), CDSCO.
He stressed that since regulations
are playing vital role in ensuring the
quality of medicines, they should
understand their responsibilities in
delivering quality services. He also
interacted with technical staff of PvPI

4 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

and emphasized that PvPI is striving in

the right direction to ensure healthcare
delivery system in the country. He
also reviewed the functioning of ICSR
processing, helpline and others activities
of PvPI.
He narrated the importance of effective
communication among the stakeholders
for the strengthening of PvPI. The
commitment of PvPI staff and progress
made was well appreciated by him.

MvPI Launched: DCG(I)

Urges Stakeholders
Commitments
Materiovigilance Programme of India
(MvPI) to monitor the safety of medical
devices in the country launched on 6th
July, 2015 by Dr. G N Singh, DCG(I) at IPC,
Ghaziabad. He emphasized that safety of
medical devices cannot be ignored and
should be monitored critically; therefore,
every stakeholder and health care
providers should be committed for the
cause. He also urged the pool of scientific
fraternity in the country to come forward
to protect the health of Indian population
by generating science based evidences,
which could be set as a gold standard for
rest of the world.

taken inspirational initiatives to make

PvPI helpline number 1800-180-3024
available in all In Patients Department
(IPD) & Out Patients Department (OPD)
prescription forms to the patients where
the main beneficiaries and one of the
main stakeholders of PvPI.

Experts during launch of Materiovigilance

Programme of India (MvPI) at IPC, Ghaziabad
on 6th July 2015

safety of medical devices. He expressed

his support in implementing all necessary
activities at his institute to function as a
National Collaborative Centre for MvPI.

IGIMS Patna Model

to Promote Patient
Safety
Indira Gandhi Institute of Medical
Sciences (IGIMS), Patna, Bihar as an
ADR monitoring centre under PvPI has

RRCTTS: More
Scope for Skill
Development
Currently four Regional Resource Centres
for Training and Technical Support
(RRCTTS) namely JSS Medical College &
Hospital, Mysuru (South zone), Seth GS
Medical College & KEM Hospital Mumbai
(West zone), PGIMER, Chandigarh (North
zone), IPGMER, Kolkata (East zone) are
functioning under PvPI to provide the
training and technical support to the
stakeholders of the respective region.
There has been a continuous requisite to
identify more RRCTTS to provide uniform
training to all AMC(s) teams in an
effective way as the PvPI is continuously
expanding by the enrolment of new
AMCs, RNTCP & ART centres under PvPI.

He stated that IPC as a National

Coordination Centre for MvPI, will provide
all support for effective implementation
and the technical support will be provided
by National Health System Resource
Centre (NHSRC), New Delhi. He
congratulated Sree Chitra Tirunal Institute
of Medical Sciences & Technology
(SCTIMST), Thiruvananthapuram for
becoming National Collaborating Centre
for MvPI. The medical devices in India are
regulated by the Central Drug Standards
Control Organization (CDSCO) which is
part of the Ministry of Health and Family
Welfare.
Dr. D S Nagesh, Scientist- G, SCTIMST,
Thiruvananthapuram narrated the vast
experiences of his institutions role and
commitment in science based approach
for promoting the quality of medical
devices. He lauded the effort of IPC for
implementing MvPI further to monitor the

PvPI-Helpline number in the Prescription form used by IGIMS Patna

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

In a significant move, the core training

panel of PvPI recommended to add five

more RRCTTS in addition to the existing

as follows:

Existing RRCTTS

States under purview

PGIMER, Chandigarh

Jammu and Kashmir

Himachal Pradesh
Uttarakhand
Punjab
Haryana
Delhi
Maharashtra
Goa
Kerala
Karnataka
Puducherry
Tamil Nadu
West Bengal

Seth GS Medical College & KEM, Mumbai

JSS Medical College & Hospital, Mysuru

IPGMER, Kolkata

Odisha
Jharkhand

New RRCTTS

States under purview

All India Institute of Medical Sciences, Madhya Pradesh

Bhopal, Madhya Pradesh
Chhattisgarh
B J Medical College, Ahmedabad, Gujarat
Gujarat
Rajasthan
Institute of Medical Sciences, Varanasi, Uttar Uttar Pradesh
Pradesh
Bihar
Nizams
Institute of Medical Sciences, Telangana
Hyderabad
Andhra Pradesh
Silchar Medical College & Hospital, Silchar, Assam
Assam
Arunachal Pradesh
Manipur
Meghalaya
Mizoram
Nagaland
Tripura
Sikkim

The initiative to recognize more RRCTTS

not only will enhance skill development
for PvPI personnel but also strengthen
the AMCs status. This will also reduces
the travel cost and time of participants.
NCC-PvPI provides technical and
financial support to RRCTTS for the
smooth functioning.

69th Independence
Day Celebrations and
Award Distribution
The 69th Independence Day was
celebrated in IPC, NCC-PvPI with zeal
and enthusiasm on 15th August 2015.
During the occasion, Dr G. N. Singh,
Secretary-cum-Scientific
Director,
IPC hoisted the tricolour flag and
paid homage to the leaders who
sacrificed their life for the independence.
He also addressed IPC officials with
his motivating words and emphasized
on working with full dedication and
commitment to achieve the goals.
During the occasion based on the
significant contribution, development
of innovative methods for ADR reporting
and expansion of PvPI, the best AMCs
were awarded. The coordinators of
the selected AMC received award and
certificate. In order to motivate the
Technical Associates working in various
AMCs they were also appreciated for
their contributions.

BEST AMCs Coordinators & Technical Associates AWARDS

Dr. Sachin Kuchya

Associate Professor & Deputy Coordinator

NSCB Medical College, Jabalpur

Notable Contributions
~~ Developing and promoting mobile android application for ADR reporting
~~ This is an unique facility for the healthcare professionals for reporting ADRs

6 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

Dr. Asha Pathak

Associate Professor & Coordinator

UPRIMS, Etawah

Notable Contributions
~~ Engaging ADR monitoring and reporting from all the departments of UPRIMS, Etawah
~~ One of the leading AMC in UP for reporting ADRs
~~ Promoting PvPI activities in near by tertiary care hospitals as well as other districts

Dr. Ramachandra Bhat

HOD & Coordinator

Govt Kilpauk Medical College, Chennai

Notable Contributions
~~ Commitment to promote the safety of vulnerable population
~~ Identification of Erythema Multiforme due to Rabies vaccine A new safety alert drawn the
attention of global community

Dr. Harihar Dikshit

Sub-Dean, Professor & Coordinator

IGIMS, Patna

Notable Contributions
~~ Creating the concept of PvPI to healthcare professionals in elaborative method
~~ Inclusion of PvPI helpline number in all OPD and IPD prescriptions of IGIMS
~~ Working for patient safety on top priority basis

Mr. Shambhu Dokania

Technical Associate, IGIMS, Patna

Notable Contributions
~~Assisted in the process of PvPI helpline number to appear in the prescriptions of IGIMS
~~ Promoting PvPI helpline through media
~~ Organizing CMEs on Pharmacovigilance

Mr. Adusumilli Pramod Kumar

Technical Associate, JSS, Mysuru

Notable Contributions
~~ Encouraged community pharmacist and nursing professionals in Mysuru about ADR reporting
and its importance
~~ More focus on reporting ADRs of vulnerable population
~~ Quality and Quantity reports submitted
Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

Mr. Mohammad Rafi

Technical Associate, SAIMS, Indore

Notable Contributions
~~ Published two case reports and one research article in reputed journals
~~ Installation of drop box in IPD and OPD
~~ Effective communication of PvPI resource material to the stakeholders
Mrs. Upasana Sharma

Technical Associate, HIMS, Dehradun

Notable Contributions
~~ Contribution in Identifying new drug safety alert
~~ Publication on Pharmacovigilance in reputed journals
~~ Sustaining good quality ICSRs (completeness score: 0.98)

Vaccines Safety Initiatives

Recommendation to
AEFI Rota vaccineIntussusception

CC-PvPI received several reports on

intussusception due to rota vaccine
from the various centres. The ICSRs
have been shared with Immunization
Technical Support Unit (ITSU) and regular
coordination meeting with Adverse Event
Following Immunization (AEFI) division of
Universal Immunization Programme is
going on to arrive conclusion. The AEFI
committee meeting which was held on
20th May 2015 at Chennai, National
Technical Advisory Group on Immunization
(NTAGI) had already limited rollout of
rotavirus vaccine adverse events. The
National AEFI committee is committed to
provide support, as and when the need
arises to pilot rotavirus vaccine rollout in
the country.

AMCs Find a Place

at State Level AEFI
Committee
The proposal by NCC-PvPI to include
coordinators of AMCs in the state level
AEFI committee was discussed in the

national level AEFI committee meeting

on 3-4th August 2015 at Patna, Bihar
and approved.

Rabies Vaccine
Associated Risk of
Erythema Multiforme
Rabies vaccine is used to treat active
immunization against rabies virus,
including pre-exposure immunization,
and post-exposure treatment following
exposure to rabies virus. In the event of
bite with a suspected rabid animal, the
same vaccine should be administered
according to the schedule.
The mild systemic Adverse Event
Following
Immunizations
(AEFIs)
reported are headache, malaise, nausea
and fever. Pain and/or swelling may
occur at the site of injection, particularly

following intradermal administration.

Serious AEFIs mainly of allergic or
neurological nature rarely occur. To
ensure the safety of Rabies vaccine, it
is also equally important to protect the
vulnerable populations safety. In India,
till August 2015 NCC-PvPI has received
two reports where rabies vaccine may
have contributed to Erythema Multiforme
(EM). This is only preliminary evaluation
report based on ICSRs received from
different AMCs under PvPI.
These cases were communicated to
Immunization Technical Support Unit
of Universal Immunization Programme,
MoHFW for further follow up with the
patients and for causality assessment.
Both the reports were not serious. The
time of reaction varies from one to
four days. Reactions were developed
after first dose of vaccination. In both
the cases, patient recovered from the
reaction.

Rabies vaccine may cause EM related life threatening

reaction since this is a new ADR associated with Rabies
vaccine, healthcare professionals are advised to monitor
and the possibility of EM in patients treated with Rabies
vaccine.

8 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

Drug Safety Information

Artemether/
Lumefantrine:
Stevens Johnson
Syndrome

Package Inserts

he 5thSignal Review Panel (SRP)

meeting held on 9th May 2015 at
CDSCO, East Zone, Kolkata with an
objective to detect signal from Indian
database and promote patient safety.
In this meeting, the ICSRs of potential
signals were evaluated and with following
outcomes:
Stevens - Johnson syndrome shall
be regarded as the potential signal
for Artemether /Lumefantrine. Apart
from SRP recommendation, WHO-UMC
also suggested for the same.

In view of the strong causal relationship

and published literature, the SRP
recommended to insert the adverse
reaction to the corresponding package
insert of following medicinal products.
~~ Mannitol Hypokalaemia
~~ Piperacillin and Tazobactam
Hypokalaemia
~~ Piperacillin and Tazobactam
Bronchospasm
~~ Rota Vaccine Intussusception
Further SRP recommends CDSCO,
to
instruct
concerned
Marketing
Authorization Holders (MAHs) to comply
the above adverse drug reactions in their
package insert.

Fig-1 Reactions Based on SOCs

Gastro-intestinal system disorders
Skin and appendages disorders
Liver and biliary system disorders
Body as a whole -general disorders
Red blood cell disorders
Urinary system disorders
White cell disorders
Respiratory system disorders
Central & peripherial nervous system disorders
Musculo-skeletal system disorders
0

Fig -2 Gender wise Distribution

of ICSRs
Female
15

Male
18

18
16
14
12
10
8
6
4
2
0

Deferasirox is indicated for the

treatment of chronic iron overload
due to frequent blood transfusions
in patients with beta thalassaemia
major aged 6 years and older.
Gender wise distribution of ICSRs
are shown in Figure 2, distribution of
ICSRs based on age groups are shown
in Figure 3, seriousness criteria and
outcome of reaction of ICSRs are
shown in Figure 4 & 5 respectively.
Graphical representation of Deferasirox
induced ADR based on the system
organ classification (SOCs) are shown
below.

Fig -4 Seriousness Criteria of

ICSRs
12

Yes
4

7
5
2
1
1
1
1
1
2

No 29

10

12

Fig -3 Distribution of ICSRs

Based on Age Groups

Among 33 reports 18 were from male

patients and 15 were from female
patients as shown in Fig- 2.

Deferasirox Induced
ADR in Paediatrics

Fig -5 Outcome of Reaction of

ICSRs
9

18
19
10

Infants

Child

Adolescents

Recovering/resolving
Not recovered/not resolved
Fatal Unknown Recovered/resolved

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

Out of total 33 cases, outcome of

3 reports were fatal, 19 reports were
not recovered, 5 reports were recovered,
9 reports were recovering, and 3 reports
were unknown (Fig. 5). In conclusion
while prescribing and monitoring this
drug we should be alert and forward such
reports to the concerned.
~~ WHO notifies Deferasirox induced
pancreatitis as a signal
~~ PvPI database shows 33 ICSRs
related symptoms of pancreatitis
~~ Healthcare professionals to
be alert while prescribing and
monitoring this drug and forward
such reports to the concerned

DPP-4 Inhibitors:
Risk of Joint Pain/
arthralgia
The U.S. Food and Drug Administration
(FDA) is warning that the type 2 diabetes
mellitus medicines sitagliptin, saxagliptin,
linagliptin, vildagliptin and alogliptin which
belongs to class of dipeptidyl peptidase-4
(DPP-4) inhibitors may cause joint pain
that can be severe and disabling.Patients
should not stop taking their DPP-4
inhibitor medicine, but should contact
their health care professional right away
if they experience severe and persistent
joint pain. Globally 246 ICSRs were found
from VigiBase on sitagliptin induced joint
pain. In India three cases were reported to
NCC- PvPI in which sitagliptin is suspected
to cause joint pain. Patients started having
symptoms of joint pain from 12 days
to two months after they started taking
sitagliptin therapy. Patients recovered from

the joint pain after they discontinued the

DPP-4 inhibitor. Healthcare professionals
are advised to be alert while prescribing
this drug and monitor the patients for
possible ADRs.
Reference - www.fda.gov

Retinopathy
Associated Epoetin
beta in Preterm
Infants
Epoetin beta is approved for the
prevention of anaemia of prematurity
in infants with a birth weight of 0.75 to
1.5 kg and a gestational age of less than
34 weeks. Epoetin beta is identical to
erythropoietin, a hormone that stimulates
the production of red blood cells. Infants
born before 31 weeks of gestation,
particularly those weighing less than 1.25
kg have an underlying risk of retinopathy
of prematurity. An European review
considered the current evidence for
retinopathy associated with Epoetin beta
treatment of anaemia of prematurity. Two
Cochrane systematic reviews assessed
the effectiveness of treatment of anaemia
with erythropoietin in premature and/or
low birth weight infants. Taken together,
the two systematic reviews suggest that
epoetin beta may increase the underlying
risk of retinopathy in premature infants.
Healthcare professionals are advised for
careful consideration of retinopathy with
epoetin beta in premature infants for
preventing anaemia of prematurity.
Reference - MHRA Drug Safety Update
volume 8 issue 10 May 2015: 3

Healthcare professionals are sensitized

to carefully monitor SGLT2 inhibitors
induced
diabetic
ketoacidosis,
DPP-4 inhibitors induced joint pain
andEpoetin beta induced increased
risk of retinopathy in preterm infants.

SGLT2 Inhibitors:
Risk of Diabetic
Ketoacidosis
Sodium-glucose
co-transporter
2
(SGLT2) inhibitors are approved for use
in adults with type 2 diabetes to improve
glycemic control. Pharmacovigilance Risk
Assessment Committee (PRAC) started a
review of canagliflozin, dapagliflozin and
empagliflozin, which belongs to class
of SGLT2 inhibitors used to treat type
2 diabetes. The aim of the review is to
evaluate the risk of diabetic ketoacidosis
with these medicines. Diabetic ketoacidosis
is a serious condition that usually develops
in people with type 1 diabetes when insulin
levels are too low. Healthcare professionals
are advised to keep close monitoring of
diabetic ketoacidosis, in patients treated
with or on treatment with SGLT2 inhibitors,
which will help in early recognition and
prompt withdrawal of the drug resulting in
lesser morbidity.
Reference: http://www.ema.europa.eu/

New Drugs Approved

Status in India
The following drugs were approved
during the period of May- August 2015
by Central Drugs Standards Control
Organization (CDSCO).

Table- 1
1

Empagliflozin Tablet 10mg As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes
mellitus.

Gadobutrol solution for In adult, adolescence and children aged 2 years and older for:
injection
~~ Contrast enhancement in cranial andspinal Magnetic Resonance Imaging (MRI).
~~ Contrast enhancement MRI of other body regions: liver kidneys.
~~ Contrast Enhancement in Magnetic Resonance Angiograpy (CE-MRA).
~~ For MRI of the breast to assess the presence and extent of malignant breast.

Teneligliptin Tablet 20mg For the treatment of type 2 diabetes mellitus as a monotherapy adjunct to diet and exercise.

10 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

Training and
Education

Existing TAs of quality improvement training programme on 20th - 21st July 2015

Quality Improvement
of TAs in AMCs

CC engages periodic refresher

courses for existing personnel
working in PvPI to enhance their
skill developments increase their
competency, boost self confidence
etc. This ultimately increases the
performance of PvPI.

The refresher course for the Technical

Associates working in various AMCs
such as STM Kolkata, IPGMER Kolkata,
VSSMC Burla, SCB Medical College
and Hospital Cuttack, JSS Medical
College & Hospital Mysuru, Sher-iKashmir Institute of Medical Sciences
Srinagar, CMC Vellore, KMC Manipal,
HIMS Dehradun, SAIMS Indore and
RGK Medical College Kolkata had
been organized on 20th-21st July 2015
at IPC, Ghaziabad. In addition to the
refresher course the performance
of Technical Associates were also
assessed.

Induction cum
Training programme
for Newly Recruited
Technical Associates
NCC- PvPI is always focused on skill
development for Technical Associates as
top priority. Since Technical Associates

are the driving force of PvPI, their skill

development is essential to fulfil the
objectives. In order to train the newly
recruited technical associates in PvPI,
NCC organized induction cum training
programme in a more systematic way by
adopting standardized training module
of Pharmacovigilance which consisted of
basic concepts of good pharmacovigilance
practice, effective Pharmacovigilance
system, mode of collecting ADRs, hands
on training VigiFlow etc. The participants
were also trained on AEFI reporting and
management and coordination with
regional RNTCP and ART centres.
First batch training of 28 participants, TAs
from Uttar Pradesh, Himachal Pradesh,
Delhi, Haryana, Chhattisgarh, Rajasthan,
Maharashtra, Gujarat and J&K, had
been organized from 18th to 22nd August
2015. In the second batch, total 26
TAs from Telangana, Andhra Pradesh,
West Bengal, Tamil Nadu, Madhya
Pradesh, Kerala and Arunachal Pradesh
participated in the training organized on
24th to 28th August 2015.
During the training the participants were
given the opportunity to experience the
field level activity of ADR monitoring and
reporting both at the government and
non government set up hospitals. At the
end of the training participants expressed
their confidence in delivering their
services in Pharmacovigilance as per the
expectations of NCC. NCC has conveyed
strong message to the participants that
the concept of PvPI and patient safety
movement should be percolated to the
rural and urban India.

Newly recruited TAs during training programme with PvPI officials

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

11

Field Level Activities

PvPI Sensitization
Programme at VSS
Medical College
Burla

sensitization
programme
was
organized by ADR Monitoring
Centre, Dept. of Pharmacology, VSS
Medical College, Burla, Odisha for the
healthcare professionals on 24th June
2015. Prof Dr. Sabita Mahapatra, Head,
Dept. of Pharmacology, VSS Medical
College, welcomed the participants
and addressed the gathering. Prof. Dr.
Suparna Chatterjee, IPGMER, Kolkata
delivered a talk on highlighting the
relevance and importance of drug safety
monitoring and reporting by clinicians
and students. The recent achievements

of the PvPI like toll free number for ADR

reporting, direct reporting by consumers
and Indias contribution to the global
drug safety database i.e. Vigibase
were elaborated upon. The meeting
ended with a vote of thanks delivered
by Dr Bhabagrahi Rath of the Dept. of
Pharmacology, VSS Medical College.All
the participants highly appreciated the
deliberation.

CME on
Pharmacovigilance
at R.D. Gardi Medical
College, Ujjain

help to maintain, develop, or increase

the knowledge, skills, professional
performance and relationships that a
physician uses to provide services for
patients, the public, or the profession
of Pharmacovigilance. R. D. Gardi
Medical College Ujjain, an AMC under
PvPI organised CME on 22nd August,
2015 for healthcare professionals
working under integrated counselling
and Testing Centre, National AIDS
Control Organization (ICTC-NACO) to
create awareness related to patients
safety and to improve ADR reporting
culture.

Continuing Medical Education (CME)

consists ofeducationalactivities which

UPCOMING EVENTS
Advanced Level
Training on Signal
Detection and Data
Mining
Signal review panel is functioning
under PvPI to identify new drug safety
alerts from the ICSRs of the Indian
Population. The importance of training
for the signal review panel members and
PvPI team was debated in the previous
meetings. NCC approached UMC
Sweden for other technical support on
the area of signal detection and data
mining. The proposal had been agreed
in principal by the Swedish delegation

headed by Dr. Marie Lindquist,

Director, UMC when they visited IPC
on 25th Nov 2014. The UMC extends
their support to strengthen the signal
review process in PvPI, subsequently
several rounds of teleconference
were
organized
and
exchanged
mutual interest. By considering the
overwhelming response from India
by providing quality ICSRs, signal
review team of UMC will be available
to IPC as trainers on 5th - 8th Oct 2015
on signal detection and data mining.
This gesture will enhance the signal
review process and NCC-PvPI expresses
sincere gratitude and acknowledges
entire UMC team for the continued
support.

Date Blocked
for Zone Wise
Coordinator Training
Two days training/ workshop on
pharmacovigilance
and
interactive
session will be organized for the
coordinators of east zone on 26th &
27thNovember, 2015 at IPGMER, Kolkata
and north zone on 8th & 9thDecember,
2015 at PGIMER, Chandigarh.
On first day, training and awareness
programme on pharmacovigilance will
be organised for the stakeholders /
partners of PvPI of respective zone
which includes coordinators, technical

12 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

associates, clinicians, pharmacists,

nurses, regulators/ policy makers &
consumer forums etc. On second day
interactive session for coordinators
and technical associates will be
organised.

WHO-IPC Gets
Ready to Welcome
International
Delegates
In association with World Health
Organisation (WHO) Country Office
(India), NCC-PvPI will be organizing 38th
Annual Meeting of WHO Programme for
International Drug Monitoring (PIDM)
in India. Dr. Nilima Kshirsagar, National

Chair in Clinical Pharmacology, Indian

Council of Medical Research (ICMR),
Government of India will be presiding
over two days workshop on WHO
ATC/DDD methodology and drug
utilization research which will be on
2nd November 2015 and second
workshop Lets talk PV! will be
conducted by UMC professionals on
3rd November 2015. Main meeting
will be held on 4 -6th November 2015.
In this regard IPC in association
with WHO Country Office are
arranging regular meetings to make
the
event
a
grand
success.
Approximately 129 countries will
participate
in
this
programme.
Following link can be accessed
for registration of this meeting.
http://www.whopvindia2015.com/umc.
aspx.

Dr. G N Singh is the

President for 67th
Indian Pharmaceutical
Congress
The 67th Indian Pharmaceutical Congress
(IPC) will be held from 19th to 21st
December, 2015 at JSS University,
Mysuru, Karnataka, Dr. G N Singh, DCG(I)
is being elected as president. This event
is focused to discuss the various issues
and current status on pharmaceutical
manufacturing, standard setting process,
regulatory, medicine safety and pharmacy
education in India as compared to global
scenario. The 67th IPC is also planned
to organise round table meeting on
Pharmacovigilance where global players
will be invited in the discussion.

News Digest
PvPI Mandates
Focussed
Pharma Companies to Pharmacovigilance
Submit ADRs in XML
on Kala-Azar
format
Kala-azar is a vector borne disease and

n order to strengthen the quality

assessment of ICSR/ to case safety,
NCC-PvPI issued an order to submit
ADR reports which is mandatory for all
the pharmaceutical industries. Now
the responses from the industries are
encouraging and their participation is
increasing. Industries have been asked
to submit their ADR reports in XML
E2B (Extensible Mark-up Language is
an electronic format which is directly
imported to our WHO UMC VigiFlow
database) format to PvPI. This format will
enable the NCC to hasten the process
of uploading the ICSRs to VigiFlow. This
message is also expected to enhance
the process of enhancement and signal
detection.

is being monitored and controlled by

National Vector Borne Disease Control
Programme
(NVBDCP).
Kala-azar
affected states are Bihar, Jharkhand,
West Bengal and Eastern Uttar Pradesh.
PvPI began to collaborate with NVBDCP
to monitor the safety of kala-azar drugs.
In this connection, the meeting was
organized by NCC-PvPI on 17th August,
2015 to discuss the work plan and road
map with the NVBDCP, MoHFW.

Working Group
Expressed Serious
Concerns over Non
Performing AMCs

The 6th Working Group (WG) of PvPI

meeting was held on 29th May, 2015
to critically examine the progress of all
the AMCs under PvPI. The members
expressed their satisfaction with the
culture of reporting of ADRs and overall
performance of AMCs. The committee
members expressed their deep concern
over the non performing AMCs. These
AMCs shall be communicated to improve
their performance in due course.

Pharmacovigilance
Preparedness
forBedaquiline
Bedaquilline was approved in India as a
combination therapy with the indication of
pulmonary tuberculosis due to multidrug
resistant Mycobacterium tuberculosis.
Central TB Division conducted a meeting
for Bedaquilline expanded Conditional
Access Programme (BDQ-CAP) for India

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

13

which was held on 21st May, 2015

at Nirman Bhavan New Delhi. In this
meeting, discussions were made about
technical and operational aspects of
BDQ-CAP and to be rolled out in six
DR-TB centres for active surveillance on
Bedaquilline. A national workshop was
conducted on Bedaquline BDQ-CAP
held on 1st to 3rd July, 2015, at New Delhi.
On the 2nd day of the workshop NCC-PvPI,
IPC officials presented national policies
and organization of Pharmacovigilance in
India.

Japanese PMDA
Delegation Visits IPC:
Scope Strengthen
the Bilateral
Relations on Medical
Devices
Japanese delegation from the office of
Standards and Guidelines Development,
Pharmaceuticals and Medical Devices
Agency (PMDA) visited IPC on 28th May
2015 to cooperate with each other in
the areas of monograph development
and medical devices safety monitoring.
Japanese delegations & NCC-PvPI
exchanged their initiatives and future
plans
in
Pharmacovigilance
and
Materiovigilance.

Japanese Delegations visited IPC-PvPI on 28th May 2015

PvPI Extends its

Destination to
Arunachal Pradesh
and Andaman &
Nicobar
As per the recommendations of 6th
WG of PvPI and also recognizing the
expectations of stakeholders, NCC acted
promptly to enhance the network of PvPI

by identifying 29 more AMCs. The new

AMCs include Arunachal Pradesh and
Andaman & Nicobar, Thus PvPI extended
its reach to monitor the drug safety in
this population too. As far as NCC is
concerned, there are lots of factors
that contribute for effective functioning
of these AMCs, including logistics,
technical, skilled manpower and most
importantly pro PV approaches of these
centres. The table shows the details of
new AMCs in PvPI.

SOUTH ZONE
1

Andhra Pradesh

Sri Venkateswara Institute of Medical

Sciences, Sri Padmavathi Medical College
for Women, Tirupati

Dr. Umamaheswara Rao

svimspharmacovigilance@gmail.com

Karnataka

ESIC-MC & PGIMSR

Rajajinagar, Bangaluru

Dr. Suchitra A.D

suchisham@hotmail.com

Sapthagiri Institute of Medical Sciences

and Research Centre, Chikkasandra,
Bangaluru

Dr. Shubha R.

shubhapreksha@gmail.com

A.J. Institute of Medical Sciences,

Kuntikana, Mangaluru,

Dr. Sharath Kumar K.

docsharath@gmail.com

S.S. Institute of Medical Sciences &

Research Centre, Davangere

Dr. Umakant N. Patil

drunpatil@gmail.com

Sri Devaraj Urs Medical College, Tamaka

Dr. Bhuvana K.

drbhuvana_k@yahoo.com

Cochin Medical College, Kalamassery,

Cochin

Dr. S. N. Veenasree

veenabiju73@yahoo.com

Government Medical College, Palakkad

Dr. N. Sunil

docsunil2005@yahoo.com

7
8

Kerala

14 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

Tamilnadu

10

Velammal Medical College Hospital and

Research Institute, Anuppanadi, Madurai

Dr. S. Thamilaras

tamilsoundar@gmail.com

Government Hospital of Thoracic Medicine, Dr. Nalini Jayanthi

Tambaram

nalinijayanthi59@gmail.com
dpstncni@rntcp.org

11

Telangana

Chalmeda Anand Rao Institute of Medical

Sciences, Bommakal, Karimnagar

Dr. Santosh Kumar. B

drsantoshkumar999@gmail.com

12

Andaman &
Nicobar

Andaman & Nicobar Islands Institute of

Medical Sciences, Portblair

Dr. Mangesh Bankar

drmangesh_bankar@yahoo.co.in

NORTH ZONE
13

Uttar Pradesh

Sarojini Naidu (S. N.)Medical College,

Moti Katra, Agra

Dr. Mona Verma

dpsupagr@tbcindia.nic.in
dpsupagr@rntcp.org

14

Chhattisgarh

All India Institute of Medical Sciences,

Tatibandh, Raipur

Dr. Suryaprakash
Dhaneria

dean@aiimsraipur.edu.in

15

Haryana

Faculty of Medicine & Allied Health

Sciences, Shree Guru Gobind Singh
Tricentary University, Budhera, Gurgaon

Dr. Naveen Kumar

nk999999@rediffmail.com

16

Punjab

Government Medical College,

New Lal Bagh, Patiala

Dr. Anita Gupta

drguptaanita@hotmail.com
gmcpharmacologypatiala@gmail.com

17

Delhi

Rajan Babu Institute of Pulmonary

Medicine and Tuberculosis, GTB Nagar,
New Delhi

Dr. Anuj Bhatnagar

anuj1968@gmail.com

National Institute of Tuberculosis and

Respiratory disease (Lala Ram Sarup
Institute of Tuberculosis And Respiratory
Diseases), New Delhi

Dr. Rohit Sarin

drsarin@yahoo.com
r.sarin@nitrd.nic.in

18

EAST ZONE
19

Assam

Assam Medical College and Hospital,

Barbari, Dibrugarh

Dr. Urmi Choudhary

urmichoudhury6@gmail.com

20

Arunachal
Pradesh

Arunachal State Hospital, Naharlagun

Dr. Dohkum Raina

medicalsupt@yahoo.com

Health Training & Research Centre,

Pasighat

Dr. T Tali

drjgibi@yahoo.com

21
22

Bihar

Katihar Medical College, Karimbagh,

Katihar

Dr. C. B Choudhary

drcb_choudhary@yahoo.co.uk

23

Odisha

Kalinga Institute of Medical Sciences and

P.B.M Hospital, KIIT University,
Bhubaneswar

Dr. Manjushree Mohanty

drmm992014@gmail.com

24

West Bengal

Midnapore Medical College & Hospital,

Vidyasagar Road, Paschim Medinipur

Dr. Balaram Ghosh

drbrghosh@gmail.com
amc.mmch@gmail.com

WEST ZONE
25

Rajasthan

Institute of Respiratory Diseases, SMS

Medical College, Subhash Nagar, Jaipur

Dr. Rajendra Singhvi

dpsrjjpr@rntcp.org

26

Gujarat

Gujarat Medical Education and Research

Society (GMERS) Medical College,
Gandhinagar

Dr. J. G. Buch

drjgbuch@hotmail.com
deangmersmcg@gmail.com

27

Maharashtra

Aundh Chest Hospital, Aundh Camp

New Sangavi, Pune

Dr. Smita Sanjeev Shiras

Dr. Mrs. Dhavle

dpsmhpna@rntcp.org

28

N.K.P. Salve Institute of Medical Sciences

& Lata Mangeshkar Hospital, Nagpur

Dr. Archana S. Borkar

drarchana50@gmail.com

29

Pandit Dindayal Upadhyay Institute of

Medical Science, Research and Human
Resources, Gadkari Wada, Nagpur

Dr. Viral Kamdar

drviralkamdar@gmail.com

Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

15

16 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

The draft version of Medicines Side Effect Reporting Form for the consumers in
Marathi (Version 1.0) is available for comments.

MEDICINES SIDE EFFECT REPORTING FORM (FOR CONSUMERS)

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5dpm1.0

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Indian Pharmacopoeia Commission, National Coordination Centre- Pharmacovigilance Programme of India, Ministry of Health & Family
Welfare, Government of India.

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Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

17

Send your report by mail or Fax to/

Sn]Ik_YxNYxNkWtlD2dkZr gWt ^tTtYkOdk

WW/
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D,&t'/
^orZagar,GhaziabadUttar Pradesh
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Email: pvpi.compat@gmail.com
&www.ipc.gov.in

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1800-180-3024

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(Nxa))

(9:00 AM to 5:30 PM, weekdays/

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Confidentiality: The patients identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the reporters identity in
response to a request from the public.

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Instructions to Complete the Reporting Form

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Section 1 - Patient Details

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Thank you for taking the time to complete this form

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18 | Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015

Hkkjrh; Hkskt lafgrk vk;ksx & ,d euks;ksx

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Newsletter: Pharmacovigilance Programme of India (PvPI) | Volume-5 | Issue -12 | 2015 |

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At NCC we take pride in the caliber of young professionals who partner with us in
delivering highest quality service in PvPI. All our team members are highly qualified &
trained in GVP in India & abroad. The care provided to promote patients safety is at par
with international standards.

Acknowledgement
NCC-PvPI acknowledges Dr. Pawan K. Saini (Scientific Officer, IPC), Technical Associates namely Mr. Akhilesh Sachan, Ms.
Archana Saurabh, Ms. Asmi Kumari, Ms. Ismeet Kaur, Dr. Itikshya Mohapatra, Mrs. Kinnari J. Dabhi, Mrs. Madhvi Rathore,
Mr. Prabhakar Mishra, Mr. Pranay Kumar, Mr. Rakesh Kumar Gupta, Mr. Ranvir Kumar, Mr. Rishi Kumar, Mr. Tanzeel Ahmad
Khan, Ms. Vaishali Bhardwaj, Mr. Vipin Kumar, Mr. Vivek Dabas, Mrs. Anusha R. (HR) and Mr. Deepak Malik (IT Consulatant)
at NCC for their contribution in bringing out this issue.

Indian Pharmacopoeia Commission

National Coordination Centre,
Pharmacovigilance Programme of India
Ministry of Health & Family Welfare
Govt. of India,
Sector-23, Raj Nagar, Ghaziabad- 201002
Tel.: 0120-2783400, 2783401, 2783392
FAX: 0120-2783311

For any other Information/Suggestions/Query contact:

Officer Incharge
Pharmacovigilance Programme of India
Email: ipclab@vsnl.net, pvpi@ipcindia.net
pvpi.ipcindia@gmail.com,
Website: www.ipc.gov.in

Let us join hands with PvPI to ensure patients safetyADR Reporting Help line (Toll Free): 1800-180-3024