NATIONAL PHARMACOVIGILANCE PROGRAMME
FOR SIDDHA DRUGS
Reporting Form for Suspected Adverse Reactions to Siddha 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.
Peripheral Center code:
State:
1. Patient / consumer identification (please complete or tick boxes below as
appropriate)
Name
Father name
Ethnicity
Address
Village / Town
Post / Via
District / State
Occupation
Patient / Record No.
Date of Birth / Age:
Sex: Male /
Female
Weight :
Degam:
2. Description of the suspected Adverse Reactions (please complete boxes below)
Date and time of
initial observation
Description of
reaction
Season:
Geographical area:
3. List of all medicines / Formulations including drugs of other systems used by
the patient during the reporting period:
Medicine
Siddha
Any other system
of medicines
Daily
dose
Route of
administration
& Vehicle Adjuvant
Date
Starting
Stopped
Diagnosis for
which medicine
taken
4. Brief details of the Siddha Medicine which seems to be toxic :
Drug – 1
Details
Drug – 2
Drug - 3
a) Name of the medicine
b) Manufacturing unit and
batch No. and date
c) Expiry date
d) Purchased and obtained
from
e) Composition of the
formulation / Part of the drug
used
b) Dietary Restrictions if any
c) Whether the drug is consumed under Institutionally qualified medical supervision or
used as self medication.
d) Any other relevant information.
5. Treatment provided for adverse reaction:
6. The result of the adverse reaction / side effect / untoward effects (please
complete the boxes below)
Recovered:
Not
Unknown:
Fatal:
If Fatal
recovered:
Date of death:
Severe: Yes / No.
Reaction abated after drug stopped or dose reduced:
Reaction reappeared after re introduction:
Was the patient admitted to hospital? If
yes, give name and address of hospital
7. Any laboratory investigations done to evaluate other possibilities? If Yes
specify:
8. Whether the patient is suffering with any chronic disorders?
Hepatic
Renal
Cardiac
Diabetes
Malnutrition
Any Others
9. H/O previous allergies / Drug reactions:
10. Other illness (please describe):
11. Identification of the reporter:
Type (please tick): Nurse / Doctor / Pharmacist / Health worker / Patient / Attendant /
Manufacturer /
Distributor / Supplier / Any others (please specify)
Name:
Address:
Telephone / E – mail if any :
Signature of the reporter:
Date:
Please send the completed form to:
Name & address of the RRCASU / PPC-ASU
The Director
National Institute of Siddha,
(Pharmacovigilance Regional Centre For Siddha Medicine),
Tambaram Sanatorium, Chennai-600 047.
 (O) 044-22381314
Fax : 044 – 22381314
Website : www.nischennai.org
Email: nischennaisiddha@yahoo.co.in
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * *
This filled-in ADR report may be sent within one month of
observation /occurrence of ADR
Who Can Report?
 Any Health care professionals like Siddha Doctors / Nurses / Siddha
Pharmacists / Patients etc.
What to Report?
 All reactions, Drug interactions,
Confidentiality
 The patient’s identity will be held in strict confidence and protected to
the fullest extent.
 Submission of report will be taken up for remedial measures only not
for legal claim