alexa Current Status & Challenges Of Pharmacovigilance Programme Of India | 14470
ISSN: 2329-6887

Journal of Pharmacovigilance
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

2nd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

Prasad Thota, V. Kalaiselvan and G. N. Singh
Accepted Abstracts: J Pharmacovigilance
DOI: 10.4172/2329-6887.S1.009
Abstract
India?s pharmaceutical market was 3rd in volume & 13th in terms of value globally in 2012, at $14 billion. Various factors have contributed to the industry?s growth in India, including the country?s aging population, changing disease profiles, growing affluence/disposable income, increasing provider penetration, and continued foreign direct investment (FDI) inflow. Despite challenges, the outlook for 2013 is promising, for three reasons: First, there is an inherent demand for health care products and services due to India?s large patient base and increasing awareness of wellness by its growing population. Second, both the government and private sectors are increasing their initiatives to improve health/well-being and enhance population coverage (including access to rural and low-tier cities). Third, the government has indicated that it will provide free drugs to the entire non-affording population and has allocated a budget of $5.4 billion for this purpose, a large part of which will go towards the purchase of medicines. In order to promote the safety of these medicines Government of India has initiated a nation-wide Pharmacovigilance programme under the aegis of Ministry of Health & Family Welfare. Indian Pharmacopoeia Commission, Ghaziabad is functioning as National Coordination Centre for Pharmacovigilance Programme since 15th April 2011 in collaboration with WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre (UMC). So far 39,523 Individual Case Safety Reports (ICSRs) have been committed to WHO-UMC through a software ?Vigiflow? (an ICSR management system developed & hosted by UMC). Method: We performed a retrospective observational study of the ADRs reported to the National Centre for Pharmacovigilance Programme of India for the period from July 2011 to March 2013. All drugs were classified using the anatomical therapeutic chemical (ATC) classification code system, and subsequently entered into a database. ADRs were considered serious if one of the following criteria were met according to the ICH E2A guidelines: the ADR is life threatening; it led to hospitalization/prolonged stay in hospital; caused congenital malformation; permanent disability; or, medically serious condition. Descriptive statistics and logistic regression using SPSS 14.0 were undertaken. Results: The results showed that among all the reported ICSRs (n=39,523), 20.4% referred to serious ICSRs (n=8088). The majority of these serious ICSRs (59%) were led to hospitalized by patients, (32.64%) belonging to other medically important serious cases (25.7%), life threatening (7.38%) and, disabled (1.61%) according to ICH E2A guidelines for seriousness. Total 39,523 ICSRs represented 47,393 ADRs of medicines, biological products (including blood-products and vaccines), herbals and traditional medicines in Indian patient?s drug safety database i.e. Vigiflow. Out of 39,523-20,158 (51%) were males, 19,010 (48.09%) were females & 16 (0.91%) with unknown gender. Out of 39,523 ICSRs-25,557 (64.66%) were reported by physicians, 7,444 (18.83%) by other healthcare professionals & 5,830 (14.75%) were by pharmacists. Out of 39,523 ICSRs-32,959 (83.39%) represents adults, 1,770 (4.47%) of elders, 1,604 (4.05%) of Infants 1379 (3.49%) of adolescents followed by 1,368 (3.46%) of child ICSRs.12, 145 (25.62%) ADRs fell in to gastrointestinal disorders for the reported 47,393 ADRs according to Vigiflow system organ class by preferred terms. Conclusion: The major challenges are distinguishing signals from background ?noise?, providing the evidence for making regulatory decisions based on strengthened signals, including changes in product information & alerting Indian prescribers, manufacturers and the public to new risks of adverse reactions.
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
Leave Your Message 24x7