Pharmacovigilance

1. Adverse Drug Reaction Reporting For Health Perspectives In
INDIA
Presented by : Kavita Bahmani
Department of Pharmaceutical Science , GJUST, Hisar Haryana.

2. Contents
Pharma Industry in INDIA
Adverse Drug Reaction Reporting
Origin of Pharmacovigilance
ADR Reporting Centres in INDIA
Importance of PV
Communication in PV
Roles and Responsibilities
Challenges in PV in INDIA
Official sites and table(list of agency)
Selected reference

3. Pharma Industry in INDIA
In 1930, in Calcutta the first pharmaceutical company
called Bengal Chemicals and Pharmaceutical Works,
which still is today as one of 5 government-owned drug
manufacturers was started.
Formulations, bulk drugs, generics, Novel Drug Delivery
Systems, New Chemical Entities, or Biotechnology, etc.
Indian companies are dominating in the marketplace
which was traditionally manned by MNC.

4. Struct
ure
People
Regulatory authority and
industry health services
Warning risk management,
Product recall etc
Pharmacovigilance centre and
safety drug advisory
committee
Data collection and analysis
Regulatory and Industry
Officials
Medical Specialist, Clinical
Pharmacist
Physicians , Health care
Professionalsm,
Pharmacists
Effects and adverse
effects reported
Pharmaceutical and
Biotechnology industries
Function
Prevention og drug related problems (ADRs )
and reduces morbidity/mortality by medicine

5. Adverse Drug Reaction Reporting
An adverse drug reaction (ADR) is an injury caused by
taking medication. ADRs may occur following a single dose or prolonged
administration of a drug or result from the combination of two or more
drugs. The meaning of this expression differs from the meaning of "side
effect” as this last expression might also imply that the effects can be
beneficial.
The study of ADRs is the concern of the field known as pharmacovigilance.
An adverse drug event (ADE) refers to any injury occurring at the time a drug
is used, whether or not it is identified as a cause of the injury

6. Origin of Pharmacovigilance
New developments in the region occurred only after an accident in
1937. In that year, the sulfonamide (Prontosil) used to treat
streptococcal infections since 1932 was introduced as a syrup
containing diethyleneglycol as a solvent.
. He was responsible for the deaths of 105 children (34 children and
71 adults) and prosecuted diethyleneglycol

7. Continued…..
The tragedy led the US Congress to ratify the Drugs, Food and Cosmetics Act
in 1938, under which drug manufacturers must demonstrate scientific
evidence of drug safety before drug manufacturers sell.
The tragedy of thalidomide is a milestone in the origin and development of
Pharmacovigilance. Thalidomide was introduced in 1957 and is said to be
harmless for nausea and morning sickness treatment.
Approximately 300 non-toxic patients have been tested. Shortly thereafter it
was associated with congenital anomalies that caused serious birth defects
in children of women who were prescribed this drug during pregnancy.

8. ADR Reporting Centres in INDIA

9. Importance of PV
A new drug released without long-term safety studies may not be therapeutically
safe and effective and may show harmful or potentially lethal effects
Morbidity or mortality and their study are essential to minimize risks and
maximize benefits
PV staff monitors ADRs, analyzes them accurately, and communicates the results
to relevant parties to ensure proper use of the drug
PVprotects the health of the population by recognizing the risk factor and the
severity of ADR, together with the prevention of unexpected additional damage

10. Communication in PV

11. Roles and Responsibilities
The PVPI-AMC coordinator is [25] responsible for the regular and effective functioning of AMC, whose charge is
entrusted to the sub-coordinator in the absence of the coordinator.
AMC nominates a technical partner responsible for the collection, monitoring, reporting, control, evaluation and
insertion of ADRs in the Vigi-Flow database. All the procedure followed according to SOP and the final evaluation is
performed by NCC.
The AMC controller / manager is responsible for sending monthly reports on the status of ADR to NCC.
The responsibility of the center coordinator in PvPI is to inform and guide HCPs, students and patients on ADR reports
through conferences, announcements, e-mails, telephones, brochures and newsletters.
The collection of comments and communications with health professionals is an additional duty of the AMC co-
ordinator.

12. Challenges of PV in INDIA
Insufficient ADR notification is the basic lagoon for the Indian PV system.
The enthusiasm of health professionals for PV energy is low, the lack of availability of advanced
tools, the basic structure, and the gap between guidelines and laws are other difficulties.
DCGI and other health authorities must invest and make regulatory decisions to build a
database and configure the full PV
Pharmacists and other health professionals must be able to identify and communicate ADR
whenever a patient is unable to see a doctor

13. WHO-UMC
• (Uppsala Monitoring Centre, SWEDEN), makes a special
contribution to raising awareness with its Take & Tell campaign,
publications and training, an active presence on social media, in
collaborations with patient organizations and much more.
• UMC is the main operational center of the WHO programmer for
monitoring of drug on international level.
• UMC currently includes a network of Pharmacovigilance centers in
near about 150 countries which represent 95 percent of global
population.
• UMC provides technical support, training to country and data
management tools which engage in signal analysis of new medicine-
related problems.

14. Official websites
The official websites www.cdsco.nic.in (CDSCO) and www.ipc.gov.in (NCC) is
the best medium for ADR communication.
The documents uploaded on this site, such as the AMC list, the information
related to ADR Reports, or how, what and where to report ADRs, can be
searched anytime and anywhere.
addition to the previous documents, the bulletins, the training module, etc.
They are also available on the website

15. List of agencies and their role in Pharmacovigilance in India
Agencies
Drug Controller General of INDIA(DCGI) It is responsible for implementing the National Pharmacovigilance
Program in India.
Central Drugs Standard Control Organization CDSCO works under the supervision of the National Drug Alert
Advisory Committee
Department of Biotechnology(DBT) Product evaluation and validation through limited and large-scale field
trials supporting clinical trials of agricultural products and healthcare
products
Ministry of Environment and Forests(MOEF) The project advisory committee approves the guidelines for data
entry by environmental experts through field trials of agricultural
products and clinical trials of health products.
Indian Council of Medical Research(ICMR) In 1980, the “Policy Statement on Ethical Considerations for Human
Subject Research” was proposed, and in 2000 these guidelines were
revised to “Ethical Guidelines for Biomedical Research in Human
Subjects”
Central Bureau of Narcotics(CBN) Closely monitor all clinical trials that require additional narcotics
companies, involving storage, import and export quotas, and research

16. Selected references
• WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva:
World Health Organization. Looking at the Pharmacovigilance: ensuring the
safe use of medicines.
• Klepper MJ. The periodic safety updates report as a Pharmacovigilance
tool. Drug Saf 2004; 27:569- 78.
• WHO Definition of Pharmacovigilance. 2002.
• Protocol for National Pharmacovigilance Program. CDSCO, Ministry of
Health and Family Welfare, Government of India, 2004.
• Olsson S (2008) Pharmacovigilance training with focus on India. Indian J
Pharmacol 40: SS28-SS30.
• Kshirsagar N (2005) The pharmacovigilance system in India. Drug Safety 28:
647-650.

17. Continued….
• Protocol for National Pharmacovigilance Program (2004) CDSCO, Ministry
of Health and Family Welfare, Government of India.
• Pharmacovigilance Program of India (2013) Guidance Document for
Spontaneous Adverse Drug Reaction Reporting 1:1-69.
• Rajamma AJ, Dubey S, Sateesha SB, Tiwari SN, Ghosh SK (2014)
Comparative larvicidal activity of different species of Ocimum against
Culexquinquefasciatus. Int J for Pharm Res Sch 3: 1916-1922.
• Indian Pharmacopoeia Commission Pharmacovigilance Program of India.
• Hugman B (2006) The Erice declaration: The critical role of communication
in drug safety. Drug Saf 29: 91-93.