PharmD graduates are completely eligible for more than 1000
jobs by Pharmaceutical Industries including PHARMACOVIGILANCE.
The National Pharmacovigilance Programme was officially inaugurated by the
Honorable Health Minister Dr.Anbumani Ramadoss on 23 November, 2004 at New
Delhi.
THE NATIONAL PHARMACOVIGILANCE CENTRE AT CDSCO
The National Pharmacovigilance Centre is based at CDSCO and shall:
1. monitor the adverse drug reactions of medicines in order to identify previously unexpected adverse drug reactions or indicate that certain reactions occur more commonly than previously believed. This will include the collation, review and evaluation of all spontaneous ADR reports received by the unit on a nation-wide basis. This information will then be keyed into the ADR database for use in aggregate analysis. These reports shall also be submitted to the WHO International Drug Monitoring Programme for international collaboration on drug safety.
2. review Periodic Safety Update Reports (PSURs) submitted by pharmaceutical companies. Pharmaceutical companies are required to submit the PSURs of all new chemicals drugs. PSURs shall be expected to be submitted every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 years.
3. maintain contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety.
4. assess the regulatory information relating to safety in order to determine what action, if necessary, needs to be taken to improve safe use. Based on the available data, the Advisory Committee shall make recommendations on product label amendments, product withdrawals and suspension.
5. provide information to end-users through adverse drug reaction news, bulletins, drug alerts and seminars.
For further information please contact:
The National Pharmacovigilance Centre
Office of Drugs Controller General of India,
Central Drugs Standard Control Organization,
Room No. 347-A,
D.G.H.S., Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi 110 011.
Tel: (11) 23018806 Fax: (11) 23012648
Email: dci@nb.nic.in www.cdsco.nic.in
Pharmacovigilance is defined as the detection, assessment and prevention of
adverse drug reactions in humans.
It is the process of:
• Monitoring medicines as used in everyday practice to identify previously
unrecognized adverse effects or changes in the patterns of their adverse effects
• Assessing the risks and benefits of medicines in order to determine what action,
if any, is necessary to improve their safe use
• Providing information to users to optimize safe and effective use of medicines
• Monitoring the impact of any action taken
The specific aims of the Pharmacovigilance Programme are to:
• contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost effective) use.
• improve patient care and safety in relation to use of medicines and all medical and paramedical interventions.
• improve public health and safety in relation to use of medicines.
• promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
The Programme aims to foster the culture of ADR notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC.
It is the process of:• Monitoring medicines as used in everyday practice to identify previously
unrecognized adverse effects or changes in the patterns of their adverse effects
• Assessing the risks and benefits of medicines in order to determine what action,
if any, is necessary to improve their safe use
• Providing information to users to optimize safe and effective use of medicines
• Monitoring the impact of any action taken
The specific aims of the Pharmacovigilance Programme are to:
• contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost effective) use.
• improve patient care and safety in relation to use of medicines and all medical and paramedical interventions.
• improve public health and safety in relation to use of medicines.
• promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
The Programme aims to foster the culture of ADR notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC.
THE NATIONAL PHARMACOVIGILANCE CENTRE AT CDSCO
The National Pharmacovigilance Centre is based at CDSCO and shall:
1. monitor the adverse drug reactions of medicines in order to identify previously unexpected adverse drug reactions or indicate that certain reactions occur more commonly than previously believed. This will include the collation, review and evaluation of all spontaneous ADR reports received by the unit on a nation-wide basis. This information will then be keyed into the ADR database for use in aggregate analysis. These reports shall also be submitted to the WHO International Drug Monitoring Programme for international collaboration on drug safety.
2. review Periodic Safety Update Reports (PSURs) submitted by pharmaceutical companies. Pharmaceutical companies are required to submit the PSURs of all new chemicals drugs. PSURs shall be expected to be submitted every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 years.
3. maintain contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety.
4. assess the regulatory information relating to safety in order to determine what action, if necessary, needs to be taken to improve safe use. Based on the available data, the Advisory Committee shall make recommendations on product label amendments, product withdrawals and suspension.
5. provide information to end-users through adverse drug reaction news, bulletins, drug alerts and seminars.
For further information please contact:
The National Pharmacovigilance Centre
Office of Drugs Controller General of India,
Central Drugs Standard Control Organization,
Room No. 347-A,
D.G.H.S., Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi 110 011.
Tel: (11) 23018806 Fax: (11) 23012648
Email: dci@nb.nic.in www.cdsco.nic.in
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