Pharmacovigilance Protocol For Asu Drugs
Pharmacovigilance Protocol For Asu Drugs
Pharmacovigilance Protocol For Asu Drugs
Department of AYUSH,
Ministry of Health & Family Welfare,
Government of India, New Delhi
&
in collaboration with
WHO Country Office for India, New Delhi
2008
PROTOCOL
NATIONAL PHARMACOVIGILANCE PROGRAMME
FOR AYURVEDA, SIDDHA AND UNANI (ASU) DRUGS
Sponsored by
Department of AYUSH,
Ministry of Health & Family Welfare,
Government of India, New Delhi
&
in collaboration with
Prof. MS Baghel
Dr. RN Acharya
Members:
1.
2.
3.
Director,
Prof. MC Sharma
Director,
Prof. MA Jafri
Director,
Director, PLIM
Dr. DR Lohar
7.
Prof. VK Joshi
BHU, Varanasi
8.
Chairman, APC
9.
Dr. SS Handa
or his representative
10. Three Experts from concerned subjects Prof. SS Savrikar
Prof. KC Singhal
Dr. Urmila Thatte
11. Chairman, PV Centre,
IPGT & RA, Jamnagar
Prof. HM Chandola
Contents
Preamble
1
2
3
12
13
14
16
17
(NPRC )
8
9
18
22
10 What to report
23
24
12 Where to report
24
25
25
26
27
17 Publication of data
29
18 Performance benchmarks
29
29
31
37
44
51
24 Annexure II
52
25 Annexure III
53
54
59
28 Reporting Form
62
Preamble
Worldwide movement for the improvement of patient safety
is gaining momentum; hence the subject of drug safety becomes
even more prominent in the present day scenario. In context of
ASU; with increased use of drugs of these systems, the scope for
adulteration, preparation of counterfeit drugs and development of
formulations which do not have conceptual basis in these
systems has increased. Further cultivation of medicinal plants
with laboratory generated species is being attempted on the
basis of chemical composition and is likely to be used in
increased manner for commercial purpose. These changes may
have profound impact on the safety and efficacy of the ASU drugs
in the market. Hence a mechanism is required to put in place to
address them. Establishment of Pharmacovigilance set up is the
first required step. Pharmacovigilance is the science dedicated to
reduce the risk of drug - related harms to patients. The number of
adverse reactions to ASU drugs reported in the National
Pharmacovigilance in India is negligible. The strong belief that
ASU medicines are safe contributes to a large extent to this
situation. To compound this matter is the lack of knowledge about
the concepts and importance of pharmacovigilance in ASU
systems among ASU practitioners.
In India, National pharmacovigilance programme under the
control of Central Drug Standards Control Organization
(CDSCO) has already been started since 2003. WHO had
emphasizes that it should include traditional medicines in
pharmacovigilance system and has published guidelines on
safety monitoring of herbal medicines in pharmacovigilance
systems in 2004.
Perceptive of the importance of Pharmacovigilance,
Institute for Post Graduate Teaching and Research In Ayurveda,
Jamnagar has already conducted a two days workshop on 3rd &
4th December 2007, on Pharmacovigilance for Ayurvedic Drugs:
Scope, Limitations & Methods of Implementation, funded by
WHO, Country Office for India, New Delhi. Based on the
recommendations of the workshop, a Pharmacovigilance Cell
(PV Cell), first of its kind in India for Ayurveda, has been
established and a Reporting Form for Suspected Adverse
Reactions of Ayurvedic Formulations has been developed and
distributed among the faculty members / research scholars /
physicians under intimation to the Department of AYUSH,
Ministry of Health and F.W., Govt. of India.
To put pharmacovigilance for ASU drugs in proper place
in India, formation of a National Pharmacovigilance Centre for
ASU Drugs, under the control of Department of AYUSH, is highly
essential which would monitor the programme centrally. This
programme aims to provide adverse drug reaction data related to
Notification
Process of informing by a notifier to any
participating pharmacovigilance centre about the
occurrence of a suspected ADR. The process may involve
informing over telephone, in person, email, fax or any other
means of communication-verbal or written. All notifiers
must give their contact details.
Appropriate and adequate measures must be taken
to keep track of the notifier. Any follow up action will be
initiated on a notification only after the due verification of
the notifier. If the notifier cannot be traced back, it will be
recorded on the notification slip before closing the case.
Notification slip
A pre-designed structured form for ADR will be
made available by the NPRC - ASU for written
communication of a suspected ADR by the notifier duly
signed by him/her wherever feasible.
ADR Form
It's the pre-designed structured form issued by
NPRC - ASU to record ADR.
Archiving
This is to be done at the NPRC - ASU.
Audit
A systematic and independent examination
(conducted by personnel, independent of the centre) of
centre's activities and documents to determine whether
centre's activities were conducted and the data were
recorded, analysed and accurately reported according to
the protocol and regarding performance of
pharmacovigilance centre's participation in National
Pharmacovigilance Programme for ASU.
Confidentiality
In a confidential / secretive manner.
Side Effect
Any unintended effect of a pharmaceutical product
occurring at doses normally used in man which is related to
the pharmacological properties of the drug.
Comment: This is an old term and is broad enough to
include both positive and negative effects of a drug apart
from its main properties or indications. Some use the term
as synonymous with 'adverse reaction', but the proposed
definition will improve clarity of use of this term.
Adverse Event / Adverse Experience
Any untoward medical occurrence that may present
during treatment with a pharmaceutical product but which
does not necessarily have a causal relationship with this
treatment.
Comment: This is a more recent term which some use
interchangeably with 'adverse reaction', but, as indicated, it
is better reserved for clinical phenomena occurring during
drug treatment where causality cannot be or is not
ascertained.
Signal
Reported information on a possible causal
relationship between an adverse event and a drug, the
relationship being unknown or incompletely documented
previously. Usually more than a single report is required to
generate a signal, depending upon the seriousness of the
event and the quality of the information.
Comment: This describes the first alert of a problem with a
drug. By its nature a signal cannot be regarded as definitive
but indicates the need for further enquiry or action. On the
other hand it is prudent to avoid a multiplicity of signals
based on single case reports since follow up of all such
would be impractical and time consuming. The definition
allows for some flexibility in approach to a signal based on
the characteristics of individual problems. Some would like
a 'signal' to include new information on positive drug effects,
but this is outside the scope of a drug safety Programme.
4
Adverse Reaction
WHO Technical Report No 498 (1972); 'A response
to a drug which is noxious and unintended, and which
occurs at doses normally used in man for the prophylaxis,
diagnosis, or therapy of disease, or for the modification of
physiological function.
Comment: This basic definition includes all doses
prescribed clinically, but is intended to exclude accidental
or deliberate overdose. The sub classification of
'unexpected' was included to facilitate understanding of
the type of adverse reaction which is most important to
report to drug monitoring agencies.
Unexpected Adverse Reaction
An adverse reaction, the nature or severity of which
is not consistent with domestic labelling or market
authorization, or expected from characteristics of the drug.
Serious Adverse Event or Reaction
A serious adverse event or reaction is any untoward
medical occurrence that at any dose:
Results in death
Is life-threatening
To avoid any confusion or misunderstanding of the
difference between the terms 'serious' and 'severe', the
following note of clarification is provided:
The term 'severe' is not synonymous with serious. 'Severe'
is used to describe the intensity (severity) of a specific
event (as in mild, moderate or severe); the event itself,
however, may be of relatively minor medical significance
(such as severe headache). Seriousness (not severity)
which is based on patient/event outcome or action criteria
serves as guide for defining regulatory reporting
obligations.
5
Common (>1%)
Dose relationship
Reproducible
Occurring in special situations or patients with increased
susceptibility
Late effects
Carcinogenicity, Mutagenicity
Interactions
Risk situations
Childhood
Adolescent
The elderly
Renal failure
Haemodialysis
Pregnancy
Lactation
Psychological Effect
Type B : Adverse Effects (Patient reactions)
Immunoallergic reactions
Metabolic intolerance
Idiosyncrasy
Rare (<1%)
Unexpected
Causality uncertain
Mechanism uncertain
No dose relationship
Characteristic, serious
Mechanism unknown
Probable / Likely
A clinical event, including laboratory test
abnormality, with a reasonable time sequence to
administration of the drug, unlikely to be attributed to
concurrent disease or other drugs or chemicals, and which
follows a clinically reasonable response on withdrawal
(dechallenge). Rechallenge information is not required to
fulfil this definition.
Comment: This definition has less stringent wording than
for 'certain' and does not necessitate prior knowledge of
drug characteristics or clinical adverse reaction
phenomena. As stated no rechallenge information is
needed, but confounding drug administration underlying
disease must be absent.
Possible
A clinical event, including laboratory test
abnormality, with a reasonable time sequence to
administration of the drug, but which could also be
explained by concurrent disease or other drugs or
chemicals. Information on drug withdrawal may be lacking
or unclear.
Comment: This is the definition to be used when drug
causality is one of other possible causes for the described
clinical event.
Unlikely
A clinical event, including laboratory test
abnormality, with a temporal relationship to drug
administration which makes a causal relationship
improbable, and in which other drugs, chemicals or
underlying disease provide plausible explanations.
Comment: This definition is intended to be used when the
exclusion of drug causality of a clinical event seems most
plausible.
Conditional / Unclassified
A clinical event, including laboratory test
abnormality, reported as an adverse reaction, about which
more data is essential for a proper assessment or the
additional data are under examination.
Un-assessable / Unclassifiable
A report suggesting an adverse reaction, which
cannot be judged because information is insufficient or
contradictory, and which cannot be supplemented or
verified.
Causality Assessment
Various causality terms are in use but the following
are used most widely. Some, however, do not use all the
terms, for instance many do not believe that a 'certain'
classification is possible for a single report and other make
no distinction between 'probable' and 'possible'. These
definitions are however acceptable to Programme
members who do use the terms. Where only 'possible' or
'unlikely' are used to describe reactions it must be
understood that 'possible' include those reactions which
are called by others 'probable' and 'certain', as well as
'possible'.
Whilst 'conditional/unclassified' and 'unassessable
/unclassifiable' are not causality terms, they describe the
status of adverse reaction reports and therefore allow for
practical communication about ADR issues.
Frequency of adverse drug reactions
Whenever possible, an estimate of frequency
should be provided, expressed in standard category of
frequency.
It is always difficult to estimate incidence on the
basis of spontaneous reports, owing to the uncertainty
inherent in estimating the denominator and degree of
under-reporting. However, whenever possible, an estimate
of frequency should be provided and in a standard form.
9
> 1/10
(> 10%)
Common (frequent)
Uncommon (infrequent) > 1/1,000 and < 1/100 (> 0.1% and < 1 %)
Rare
Very rare
< 1/10,000
(< 0.01%)
11
Member Secretary :
Co-ordinator, NPRC
Members:
1.
2.
3.
4.
5.
6.
Director, PLIM
7.
8.
Chairman, APC
9.
12
Members:
1. Director, CCRAS
2. Drug Controller of ASU Drugs
3. Four members from RPCs. One each from Siddha
and Unani. Remaining two from Ayurveda. The
representation should for two years.
4. One Advisor from ASU systems. Nominated by
Secretary, Dept. of AYUSH
Representatives from Subject Specialties:
5.
6.
7.
8.
9.
10.
11.
12.
13.
13
Short-term objectives:
To develop the culture of notification.
Medium-term objectives:
To involve healthcare professionals and
professional associations in the drug
monitoring and information dissemination
processes.
14
Long-term objectives:
To achieve operational efficiencies that
would make National Pharmacovigilance
Programme for ASU drugs a benchmark
for global drug monitoring endeavours.
make National Pharmacovigilance
Programme for ASU drugs a benchmark
for global drug monitoring endeavours.
Since ages Ayurveda, Siddha and Unani systems
are being practised in India. Now in this era of
globalization certain concerns are raised with regards to
their safety. On Indian plants or Indian plant based
products severe toxicity is yet to be reported. Ayurveda
has categorized toxic plants separately and for their use
special processing is essential. There is a wide spread
misconception that all drugs of natural origin are safe.
There is also a common belief that long term use of a
medicine based on tradition, assures both safety and
efficacy. Further when traditional (ASU) medicines are
used in conjunction with other medicines there is the
potential of serious adverse drug interactions. There are
also examples of traditional (ASU) medicines being
adulterated or contaminated with allopathic medicines,
chemicals such as corticosteroids, non-sterodial antiinflammatory agents etc. Further many ASU drugs are
manufactured for global use and they have moved
beyond the traditional and cultural framework for which
they were originally intended. Currently, the majority of
adverse events related to the use of herbal / traditional
products that are reported are attributed either due to poor
product quality or to improper use.
ASU systems of medicines have their own
principles, have their own pharmacopoeia, but are
practised in the country as OTC drugs and without an
authentic prescription. A recent WHO survey showed that
around 90 countries, less than half of WHO's member
state, currently regulate herbal medicines.
15
16
6 . T H E N AT I O N A L P H A R M A C O V I G I L A N C E
RESOURCE CENTRE AT IPGT&RA
The National Pharmacovigilance Resource Centre,
IPGT & RA:
a
17
ASU Drugs.
Uniform training will be given to all the participating
centres. Intensive interaction / training sessions will be
organized for all participants to:
Each PPC
To record some ADRs each month (statistically
speaking 30 ADR in about 1000 patients who visit
each month would be quite easy to record)
Completed ADR forms shall be forwarded to the
concerned RPC at the end of each month under
intimation to concerned AYUSH authority.
ii
Each RPC
a. To collate and scrutinize the data received from PPC
b. To perform the causality analysis of all the forms
received every month.
c. To submit a monthly report prepared in a specific
form to be forwarded to National Pharmacovigilance
Resource Centre (NPRC - ASU) every month.
d. To report any alarming ADRs with in 24 hrs. to
NPRC - ASU along with supporting evidence.
iii
NPRC
a. To collate the data received from RPCs and
its own centre.
b. To verify / validate the causality analysis.
c. To prepare Monthly Information Sheet (MIS)
reports in a specified format.
d. To pass on the final data to National
pharmacovigilance Technical Advisory
Committee ASU (NPTAC - ASU) for analysis.
e. To pass the analysed data to Department of
AYUSH, Govt of India for further necessary
19
action.
To call a meeting of NPCC- ASU as and when
necessary.
g. To publish a periodic newsletter
h. To generate awareness by distributing
brochures rhroughout the country particularly in
different ventures like CME / RoTP / Workshops
/ Seminars etc.
i. To initiate for incorporation of Pharmacovigilance
Systems as a part of curriculum in UG and PG
(particularly in DG / RS & BK subjects) syllabus
of Ayurveda.
f.
20
RPC :
A teacher of Dravyaguna / Rasashastra, Bhaishajya
Kalpana / any clinical department / Agadatantra, allied
departments of Siddha and Unani systems of medicines,
preferably not below the rank of Sr. Lecturer / Assistant
professor, attached to an ASU medical college, and
Assistant Director (ASU)
NPRC :
A teacher of Dravyaguna / Rasashastra, Bhaishajya
Kalpana / any clinical department / Agadatantra not below
the rank of an Asso. Professor.
All coordinators must obtain official permission, in
writing; from their respective head of the institution / chief
of the hospital, and submit the document to the NPRC.
NPRC will appoint dedicated Ayurvedic
pharmacologist and data managers (project staff). The
Ayurvedic pharmacologist must be computer literate. The
data manager must have sufficient competence in
database designing, data entry and data analysis.
Study population:
Anyone experiencing adverse events suspected to be
caused by ASU drugs.
Causality Assessment:
As per WHO recommended methodologies.
Archiving:
All data generated (including reporting forms) will be
stored and preserved for the purpose of archiving for a
minimum period of 5 years, at the NPRC.
Confidentiality:
Patient's identity is not revealed on the form only
the patient identifier is mentioned. Identity of the patients
and related data will be used only for research and
regulatory purpose and sufficient measures will be taken
to maintain confidentiality of such information.
21
Posters
23
a.
b.
c.
d.
Death
Life threatening (real risk of dying)
Hospitalisation (initial or prolonged)
Disability (significant, persistent or
permanent)
e. Congenital anomaly
f. R e q u i r e d i n t e r v e n t i o n t o p r e v e n t
permanent impairment or damage
The prescribed 'Adverse Drug Event Reporting
Form For ASU Drugs' shall be used for the purpose of
National Pharmacovigilance Programme For ASU.
10. WHO CAN REPORT
Any health care professional may report suspected
adverse drug events. The Programme shall not accept
reports from lay members of the public or anyone else who
is not a health care professional. Others can report through
the physicians under whom he / she had undergone
treatment.
Drug Related Information Report:
Consumer may directly report to the concerned PPC /
RPC / nearest health centre or physician regarding the
suspected ADR
11. WHERE TO REPORT
The reporting on prescribed format will be done to any
of the Pharmacovigilance centres.
24
Legibility
In order to avoid receiving fake unauthentic reports
or reports by parties having vested interests against any
drug(s).it is important that the reporter's identity is clearly
stated in the form so that the reporter can be approached
to verify the authenticity of the entire report.
25
Sl.
No
1
2
3
4
5
6
7
8
9
10
11
12
Responsibilities
within 24 Hrs.
To forward periodic reports to next higher
centre in first week of every month.
To liaison with healthcare professionals in
26
15. IMPORTANT:
RPC and NPRC are acknowledged to have
comparable professional competence. Their hierarchical
position is only for administrative and management
purposes (NPRC has the additional responsibilities for data
collation, statistical analysis and archiving). Concurrence
for selection of new PPCs / RPCs will be given by the NRPC
in consultation with NPCC-ASU. If a new centre is being
proposed to replace a non functional PPC or RPC, the
NPCC-ASU shall provide their opinion/concurrence in not
more than one month.
New centres may join the Programme depending
on the need in a particular territory and availability of
resources to support new centre(s). The request may be
forwarded through the respective RPC / NPRC to the
NPCC-ASU which will take a final decision in this regard. In
all cases, Head of the Institution desiring to join the
Programme must give administrative clearance to this
effect.
16. MANAGEMENT INFORMATION SYSTEM
Sl
No
01
02
03
04
05
06
07
PPC to RPC
RPC to NPRC
NPRC to NPCC
Period of report
Period of report
Period of report
Number of
Number of
Number of
reportings
reportings
reportings
received in the
received in the
received in the
preceding period?
preceding period?
preceding period?
Number of ADR
Number of ADR
Number of ADR
reports
reports
reports
Number of serious Number of serious
Number of serious
(or suspected serious (or suspected serious (or suspected serious
ADR reports(if any) ADR reports (if any) ADR reports (if any)
Number of serious Number of serious
Number of serious
(or suspected serious (or suspected serious (or suspected serious
ADR reports
ADR reports
ADR reports
forwarded within
forwarded within
forwarded within
specified time.
specified time.
specified time.
Number of serious Number of serious
Number of serious
(or suspected serious (or suspected serious (or suspected serious
ADR reports not
ADR reports not
ADR reports not
forwarded within
forwarded within
forwarded within
specified time.
specified time.
specified time.
Reason for delay
Reason for delay
Reason for delay
27
08
09
10
11
12
13
14
15
16
17
18
19
20
21
Important
Important
happenings
happenings
or developments
or developments
(events that
(events that
happened other than happened other than
the way they should the way they should
have happened or have happened or
events that didnt
events that didnt
happen the way they happen the way they
should have
should have
happened)
happened)
Total No. of ADR
Total No. of ADR
forms received
forms received
No. of ADR forms No. of ADR forms
in which causality in which causality
assessments ADR assessments ADR
Any other
New PPC identified
observations
and recommended
if any
Important
happenings
or developments
(events that
happened other than
the way they should
have happened or
events that didnt
happen the way they
should have
happened)
Total No. of ADR
forms received
No. of ADR forms
in which causality
assessments ADR
No of
recommendations
from RPC for new
PPC
No. of notifications / No. of ADR forms
reports received
received from RPC in
from each centre
which causality
assessment has
been ADR
No. of reports
No. of ADR forms
inappropriately filled in received from RPC in
by respective PPCs which causality
assessment has
been verified /
reassessed
(all SAEs and10 % of
all remaining)
Actions taken /
No. of forms archived
recommended
Monitoring
Monitoring
activities done
activities done
Acknowledgments
No. of notifications /
sent in time
reports received from
each centre
CME awareness
No. of reports filled in
activities if any
inappropriately by
respective Regional
Centres
Any other
Actions taken /
observations
recommended
Acknowledgments
sent in time
CME & awareness
activities if any
Any other
observations
28
29
30
20.
Background
Assignment:
To manage the Peripheral Pharmacovigilance
centres For ASU Drugs.
31
32
14.
15.
34
S. No.
Task
Time Schedule
1.
2.
3.
4.
Monthly
5.
Monthly
6.
Monthly
7.
8.
9.
10.
11.
12.
13.
14.
35
Monthly
b)
2.
3.
36
Background
38
9.
10.
11.
12.
13.
14.
15.
40
S. No.
Task
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Time Schedule
41
Monthly
Monthly
Monthly
Monthly
14.
15.
16.
17.
Quarterly
42
1.
2.
3.
Period of Report
Number of notifications received in the
preceding period
Number of Reports ADR and number of
serious or suspected serious ADR reports, if
any
Number of serious or suspected serious ADR
reports forwarded with in the specified time
Number of serious or suspected serious ADR
reports not forwarded with in the specified
time along with the reasons for delay
Important happenings or development
Total number of ADR forms received
Number of recommendations from
Peripheral Pharmacovigilance centres for
new peripheral pharmacovigilance centre
Total no. of ADR forms received from
Peripheral Centre in which causality
assessments has been ADR
Number of ADR forms received from
Peripheral Centre in which causality
assessment has been verified / reassessed
Number of forms archived
Monitoring activities done
No. of notifications / reports received from
43
14.
15.
16.
17.
18.
each centre
No. of reports filled in inappropriately by
respective Peripheral Centres
Actions taken / recommended
Acknowledgements sent in time
CME awareness activities if any
Any other observations
22.
Background
44
Assignment:
To manage the National Pharmacovigilance centre
For ASU
The overall objective as per the National
Pharmacovigilance Programme for ASU will be:
a.
b.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
46
17.
S. No
Task
Time Schedule
1.
2.
3.
4.
5.
6.
7.
47
Monthly
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
48
Monthly
Monthly
6 months in
addition to
induction of
training
.
Financial support under the Project
The following financial support shall be provided by
NPRC:
1.
2.
3.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Period of Report
Number of notifications received in the
preceding period
Number of Reports ADR and number of
serious or suspected serious ADR reports,
if any
Number of serious or suspected serious
ADR reports forwarded with in the specified
time
Number of serious or suspected serious
ADR reports not forwarded with in the
specified time along with the reasons for
delay
Important happenings or development
Total number of ADR forms received
Number of recommendations from
Regional Pharmacovigilance centres for
new peripheral pharmacovigilance centre
Total no. of ADR forms received from
Regional Centre in which causality
assessments has been ADR
Number of ADR forms received from
Regional Centre in which causality
assessment has been verified / reassessed
Number of forms archived
Monitoring activities done
No. of notifications / reports received from
each centre
No. of reports filled in inappropriately by
respective Regional Centres
Actions taken / recommended
Acknowledgements sent in time
CME awareness activities if any
Any other observations
50
Annexures
Annexure 1
Eligibility criteria for identifying a PPC
i.
ii.
iii.
iv.
v.
vi.
51
Annexure 2
Duties of Coordinators:
*
*
a.
b.
c.
d.
52
Annexure 3
North Region
Delhi
Punjab
Himachal Pradesh
Jammu & Kashmir
Uttar Pradesh
Uttarakhand
Haryana
South Region
Kerala
Karnataka
Tamilnadu
Andhra Pradesh
East Region
Assam
West Bengal
Orissa
All north east sates
West Region
Maharastra
Gujarat
Goa
Rajasthan
Central Region
Madhya Pradesh
Chattishgarh
Bihar
Jharkhand
53
Coordinator's name
North
Faculty of Ayurveda
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi, UP
Dr Anand Choudhury
Reader, Dept.
of RS&BK,
South
Dr Gopa Kumar,
Lecturer, Roganidana
East
Dr Anup Vaishya
Asst. Prof.
West
Central
Dr N Srikanth,
Asst. Director (Ayu)
Unani
Dr Tanzeel Ahmed
Lecturer
Dept. of Moalejat
Siddha
National institute of
Siddha, Tambaram
Sanatorium,
Chennai - Tamilnadu
Dr P. Selva
Shanmugum
54
Coordinator's name
North Region:
1. Delhi
2. Punjab
Dr Navneet Sharma
Dr Debasis Panda
Lecturer, Dravyaguna
5. Uttar
Faculty of Ayurveda,
Pradesh Institute of Medical Sciences,
Banaras Hindu University,
Varanasi, UP
Dr A K Tripathy
Reader, Kayachikitsa
Dr P K Mishra,
Lecturer,
Dravyaguna
6. Uttarakhand
Govt. Gurukul Ayurved
College, Gurukul Kangari
Haridwar
7. Haryana Gaur Brahmin Ayurved
College & Hospital,
Village Branmanawas
Distt. Rohtak
Haryana
55
Dr Sumer Singh
South Region
1. Kerala
Govt. Ayurved College ,
MG Road
Thiruvanathapuram
Dr Gopa Kumar
Lecturer
Roga nidana
Dr. Mahesh C.
Kundagol
Dr Girish
Dr P.H.C. Murthy
Lecturer, RS&BK
Government Ayurved
College, Jalukbari,
Guwahati,
Assam
Dr Anup Vaishya
Asst Prof.
2. West
Bengal
Dr Prasanta Sarkar,
Lecturer,
3. Orissa
Gopabandhu Ayurveda,
Mahavidyalaya,
Puri, Orissa
56
West Region
1.Maharastra
Tilak Ayurved
Mahavidyalaya
583/2, Rasta Peth,
Pune
2. Gujarat
Govt. Akhandanand
Ayurved Mahavidyalaya
Opp. Victoria Garden Bhadra
Ahmedabad
Gujarat
3. Goa
Bharteeya Sanskrit
Prabodhini Gomantak
Ayurved Mahavidyalaya &
Research Centre, Vajem,
Shiroda
Distt. South Goa,
Goa
4. Rajasthan
National Institute of
Ayurveda,
Madhav Vilas Palace,
Amer Road
Jaipur,
Rajasthan
Dr P Suresh
Asso. Prof.
RS&BK
Central Region
1. Madhya Pt. Khushilal Sharma
Dr R K Pati
Pradesh Govt. Ayurved
Sr Lect. RS&BK
Maha Sansthan,
Bharat scouts & Guide Bhawan
Shyamala Hills Road
Bhopal, MP
2. Chattishgarh
Govt. Ayurved College
Raipur
Dr R P Gupta
Reader D.G.
3. Bihar
DR R. A. Singh
Dravyguna
Government Ayurved
College Post-Graduate
Training & Research
Institute, Kadam Kuan
Patna ,
Bihar
57
4. Jharkhand
Surya Mukhi Dinesh
Ayurved Medical College &
Hospital, Dinesh Nagram
Booty, Ranchi
Jharkhand
CCRAS
Unani
2. Faculty of Medicine
Dr. Akhtar Siddiqui
(Unani) Jamia Hamdard,
Hamdard Nagar, New Delhi 62
3. Govt. Nizamia Tibiya College
Charminar, Haidrabad
Siddha
58
Dr. S. K. Sharma
Advisor - Ayurveda, Department of AYUSH
Ministry of H. & F.W., Govt. of India, New Delhi
Prof. K. C. Singhal,
Vice Chancellor, NIMS University, NIMS City
Centre, 4, Govind Marg, Jaipur - 302 004
Prof. G. P. Mohanta,
rd
WHO Country Office for India, 3 Floor,
Sri Ram Bharatiya Kala Kendra
1, Copernicus Marg, New Delhi
Dr. D. C. Katoch,
National Consultant
(Traditional Medicines & Homoeopathy)
WHO Country Office for India
rd
3 Floor, Sri Ram Bharatiya Kala Kendra
1, Copernicus Marg, New Delhi
Dr. A. Pasha,
Deputy Advisor (Unani),
Department of AYUSH,
Ministry of H. & F.W., Govt. of India, New Delhi
Prof. M. C. Sharma,
Director
National Institute of Ayurveda
Madhav Vilas Palace, Amer Road, Jaipur,
Rajasthan- 302 002
59
Prof M. S. Baghel,
Director
IPGT&RA, Jamnagar, Gujarat
Dr. G. S. Lavekar,
Director, CCRAS,
No.61-65, Institutional Area,
Opp. 'D' Block, Janakpuri, New Delhi
10
Prof. M. A. Jafri,
Director,
National Institute of Unani Medicine,
Kottige Palya, Magadi Main Road,
Bangalore - 560 091
11
Prof. V. K. Joshi,
Dean, Faculty of Ayurveda, IMS,
BHU, Varanasi, UP, 221 005
12
13
Prof. H. M. Chandola,
Dept. Of Kayachikitsa &
Chairman, Pharmacovigilance Cell
IPGT&RA, GAU, Jamnagar, 361 008
14
15
Dr. A. K. Choudhury,
Reader, Dept. of RS & BK,
Faculty of Ayurveda, IMS, BHU,
Varanasi, UP, 221 005
16
60
17
Dr. Ravishankar,
Head, Pharmacology Cell,
IPGT&RA, GAU, Jamnagar, 361 008
18
Dr. R. N. Acharya,
Member Secretary,
Pharmacovigilance Cell,
IPGT&RA, GAU Jamnagar-361 008
19
Dr. Galib,
Lecturer, Dept. Of RS & BK, GAU, IPGT&RA,
Jamnagar-361 008
20
21
Dr B. S. Behera,
Scientific Officer
Commission for Scientific &
Technical Terminology, (CSTT)
Ministry of HRD, New Delhi
22
Dr N Shrikanth,
Asst. Director (Ayu),
CCRAS, New Delhi
23
24
61
NATIONAL
PHARMACOVIGILANCE
PROGRAMME FOR AYURVEDA,
SIDDHA & UNANI (ASU) DRUGS.
Reporting Form for Suspected
Adverse Reactions to ASU Drugs
Please note: i. All consumers / patients and reporters
information will remain confidential.
ii. It is requested to report all suspected
reactions to the concerned, even if it
does not have complete data, as soon as
possible.
1. Patient / consumer identification (please complete
or tick boxes below as appropriate)
Name
Patient Record
Ethnicity
IPD / OPD Number (PRN)
Address
Age:
Village / Town
Sex:
Post / Via
Male / Female
District / State
Prakriti / Mizaj:
62
Date
Starting Stopped
Renal
Malnutrition
Cardiac
Any Others
63
Date:
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