pharmacovigilanc

1. Vd. Sudipt Rath, M.D., Ph.D. (Dravyaguna)
Asst. Professor (DG) & Co-Ordinator, IPvCC,
National Institute of Ayurveda, Jaipur
sudipt@gmail.com 91 9828376668
ADRs & Misleading
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2. What is Pharmacovigilance ?
• Derived from 2 words
• Pharmacon = Drug
• Vigilare = To be alert / To keep watch
Defined as the pharmacological science dealing with
Detection
Assessment
Understanding
Documentation &
Prevention
of Adverse Drug Events for
Short & Long term Safety of the drugs.

3. WHO CONSTITUTION - Chapter 2
• Article 2, Function (u)
• to develop, establish and promote international standards with respect to food,
biological, pharmaceutical and similar products;
• Article 21, Functions (d) & (e)
• standards with respect to the safety, purity and potency of biological,
pharmaceutical and similar products moving in international commerce;
• advertising and labelling of biological, pharmaceutical and similar products moving
in international commerce.

4. ERICE DECLRATION - 2006
• Every Country needs a system with independent expertise to ensure that
• SAFETY INFORMATION ON ALL AVAILABLE DRUGS ARE ADEQUATELY
COLLECTED.
• Communication is critical in drug safety.

5. TRADITIONAL MEDICINE
• To define the use of practices
there is a need to strengthen
• SAFETY, PROPER USE
& EFFECTIVENESS of
• Products, Practices
& Practitioners.

6. AYURVEDA PERSPECTIVE…
• RATIONAL, SAFE & EFFECTIVE
• तदेव युक्तं भैषज्यं यदारोग्याय कल्पते|
स चैव भभषजां श्रेष्ठो रोगेभ्यो यः प्रमोचयेत्||
• युक्तक्तव्यपाश्रयं

7. AYURVEDA PERSPECTIVE…
• ओषधीर्ाामरूपाभ्यां जार्ते ह्यजपा वर्े|
अभवपाश्चैव गोपाश्च ये चान्ये वर्वाभसर्ः||
र् र्ामज्ञार्मात्रेण रूपज्ञार्ेर् वा पुर्ः|
ओषधीर्ां परां प्राक्ततं कभश्चद्वेभदतुमर्ाभत||

8. AYURVEDA PERSPECTIVE…
• यथा भवषं यथा शस्त्रं यथाऽभिरशभर्याथा|
तथौषधमभवज्ञातं भवज्ञातममृतं यथा||
औषधं ह्यर्भभज्ञातं र्ामरूपगुणैक्तस्त्रभभः|
भवज्ञातं चाभप दुयुाक्तमर्थाायोपपद्यते||
योगादभप भवषं तीक्ष्णमुत्तमं भेषजं भवेत्|
भेषजं चाभप दुयुाक्तं तीक्ष्णं सम्पद्यते भवषम्||

9. MODERN PERSPECTIVE...

10. To sum up…
• Drugs can Produce Undesired Harmful effects
• Thus, physician must evaluate drugs before use.
• Entire process of being watchful of the possible adverse drug effects comes under
ambit of Pharmacovigilance.
• Ensures the intended use of drug in society – improve health in a cost effective
manner.

11. AIMS OF PHARMACOVIGILANCE …
• Early detection of unknown safety problems
• Detection of increases in frequency
• Identification of risk factors
• Quantifying risks
• Preventing patients from being affected unnecessarily.

12. Terminology
ADVERSE DRUG REACTION
• Noxious, unintended and undesired effect of a drug
• Occurs at a dose normally used in humans for prophylaxis,
diagnosis, therapy or modification of physiological functions
ADVERSE EVENT
• Untoward medical occurrence
• Occurs during a treatment with a drug
• Not necessarily have a causal relationship

13. 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
Terminology

14. NEED OF PHARMACOVIGILANCE …
ASU Drug Perspective
• MYTHS
• ASU DRUGS ARE ABSOLUTELY SAFE
• ADRS DON’T HAPPEN WITH NATURAL DRUGS.
• NO NEED FOR PHARMACOVIGILANCE IN ASU.
REALITY
ADRs associated with ASU drugs are less but present.
Many Poisons are also natural substances.
Thus, there is a need of PHARMACOVIGILANCE in ASU.

15. PVG IN AYURVEDA IN CONTEMPORARY ERA

16. REVAMPED PHARMACOVIGILANCE SYSTEM FOR
ASU DRUGS IN INDIA

17. NATIONAL PHARMACOVIGILANCE
PROGRAMME (ASU) – CURRENT NETWORK
NODAL AGENCY - Ministry of AYUSH, New Delhi
National Pharmacovigilance Co-ordination Centre (NPvCC) –
AIIA, New Delhi.
5 Intermediary Pharmacovigilance Centers (IPvCC) – NIA,
Jaipur, IPGTRA, Jamnagar for Ayurveda.
73 Peripheral Pharmacovigilance Centers (PPvC)
www.ayushsuraksha.com

18. PHARMACOVIGILANCE PROGRAMME
PROGRAMME MODE – CONTINUITY.
FUND ALLOCATED - FEASIBLE.
RESPONSIBILITIES DEFINED - ACCOUNTABILITY.
ADDITION OF MISLEADING ADVERTISEMENT.

19. ADR REPORTING

20. Reporting Form for Suspected Adverse Reactions
National Pharmacovigilance Program for ASU & H
Drugs
Note:
Personal information will be kept confidential.
All suspected reactions are to be reported with relevant details.
Ay-AIIA Ay-NIA Ay-IPGT Un-NIUM Si-NIS Ho-NIH
Code of Peripheral Centre ADR Number / Year

21. 1. Patient / consumer identification (please
complete or tick boxes below as appropriate)
Patient Initials: Patient Record Number (PRN)
Place of Birth
IP
D
/
O
P
D
Address:
Village / Town:
Post / Via:
District / State:
Age:
Sex: Male / Female / Others
Diagnosis: Constitution and Temperament:

22. 2. Description of the suspected Adverse Reactions
Date and time of initial observation
Description of reaction
3. Whether the patient is suffering with any chronic disorders?
Hepatic Renal Cardiac Diabetes Any
Others (Specify, if others)
4. Addictions, if any? If yes, please specify:
5. H/O previous allergies / Drug reactions, if any: If yes, please
specify:

23. 6. List of all ASU & H drugs used by the patient
during the period of one month:
Name of
the
drug
Manufacturer /
Batch no.
Dose
Form / Route
of
administration
Date of
Reaso
n for
use
Any
unwanted
occurrence
s
Starting
Stopped /
Continued

24. 7. List of other drugs used by the patient during
the period of one month:
Name
of the
drug
Manufacturer /
Batch no.
Dose
Form / Route
of
administratio
n
Date of
Reason
for use
Any
unwanted
occurrenc
es
Starting
Stopped /
Continued

25. 8. Details of the drug suspected to cause ADR:
1. Name of the drug:
2. Manufacturing date and Expiry date (if available):
3. Remaining pack / label (if available):
4. Consumed orally along with (water / milk / honey / or any other)
5. Whether any dietary precautions have been prescribed?
6. If yes, please specify:
7. Whether the drug is consumed under medical supervision or used as self medication.
8. Any other relevant information associated with drug use:

26. 9. Management provided / taken for suspected
adverse reaction
10. Please indicate outcome of the suspected adverse
reaction (tick appropriate)
Recovered: Not recovered: Unknown: Fatal: If Fatal
Date of death:
Severe: Yes / No. Reaction abated after drug stopped or dose reduced:
Reaction reappeared after re administration of drug:
Was the patient admitted to hospital? If
yes, give name and address of hospital

27. 11. Any abnormal findings of relevant laboratory
investigations related to the episode done pre and
post episode of ADR:
12. Particulars of ADR Reporter:
Please tick: Patient / Attendant / Nurse / Doctor / Pharmacist / Health worker / Drug
Manufacturer / Any others (please specify)
Name:
Address:
Telephone / E - mail:
Signature of the reporter:
Date:

28. Please send the completed form to: The centre
from where the form is received or to
The Coordinator, National Pharmacovigilance
Coordination Centre (NPvCC)
All India Institute of Ayurveda (AIIA), Mathura
Road, Gautam Puri,
Sarita Vihar, New Delhi - 110 076
E-mail: pharmacovigilanceayush@gmail.com,
ayush-pharmavig@aiia.gov.in

29. MISLEADING ADVERTISEMENT

30. PROACTIVE MINISTRY
Insertion of Rule “170 Prohibition of advertisements
of Ayurvedic, Siddha or Unani drugs” - Drugs and
Cosmetics (Eleventh Amendment) Rules, 2018.

31. RULE 170
(1) The manufacturer or his agent, of Ayurvedic, Siddha
or Unani drugs, shall not participate in the publication of
any advertisement relating to any drug for the use of
diagnosis, cure, mitigation, treatment or prevention of
any disease, disorder, syndrome or condition.

32. RULE 170
(2) The Ayurvedic, Siddha or Unani drug shall be
advertised for the purpose other than specified in sub-
rule (1) after the allotment of the Unique Identification
Number.

33. RULE 170
(3) The manufacturer of the Ayurvedic, Siddha or Unani drug shall
apply for the Unique Identification Number for the advertisement
issued or aired before this notification, within the period of three
months from the date of the publication of this notification.

34. RULE 170
(4) The application for advertisement shall be rejected if,
(i) it is incomplete; or
(ii) the intended advertisement does not contain the contact
details of the manufacturer; or
(iii) the contents of the advertisement directly or indirectly
tantamount to vulgarity or obscenity; or

35. RULE 170
(4) (iv) it refers to any Ayurvedic, Siddha or Unani drug in terms
which suggest or calculated to lead to the use of
that drug or medicine for the enhancement of height and
dimensions or capacity of performance of male
or female sexual organs; or
(v) it depicts photographs or testimonials of celebrities or
government officials; or

36. RULE 170
(4) (vii) it gives a false impression about the true
character of Ayurvedic, Siddha or Unani drug; or
(viii) it makes a misleading or exaggerated claim about
the effectiveness of the said drug.

37. RULE 170
(15) The State Licensing Authority may suspend or
cancel the license of the manufacturer of the Ayurvedic,
Siddha or Unani drug as per the provisions of Rule 159,
in case the directions given by the said authority is not
complied.

38. ADVISORY
Not to advertise

39. I & B Min..
Prohibits use
of Govt. Dept. /
Inst. In Ad...

40. National Pharmacovigilance Programme –
ASU aims that new information be rapidly
and effectively incorporated into
therapeutic decision making by Physicians
in benefit of Patients .
….. thus, you are the most important part
of the programme.