India's Drugs Control Department within the Ministry of Health & Family Welfare initiated the establishment of a nationwide network to build a comprehensive pharmacovigilance data system in 2004. The National Pharmacovigilance Advisory Committee (NPAC) was created under the chairmanship of the Director General of Health Services and the Drug Controller General of India (DCGI), who functions as the member secretary of the Committee. Based at the Central Drugs Standard Control Organization, NPAC was assigned the primary responsibility of setting up the system to monitor the pharmacovigilance programme throughout the country. The National Pharmacovigilance Programme for India is sponsored by the World Health Organization (WHO) and is funded by the World Bank.The NPP is based on the recommendations made in the WHO document titled "Safety Monitoring of Medicinal Products - Guidelines for Setting Up and Running a Pharmacovigilance Centre".




The National Pharmacovigilance Programme at CDSCO aims to:

(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.

SOURCE: CDSCO (http://cdsco.nic.in/)

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BACKGROUND FOR NATIONAL PHARMACOVIGILANCE PROGRAMME

Previously new drugs used to be introduced in the Indian market several years after they were launched in other countries. The regulatory bodies in India approved drugs based on the data generated in the countries where these products were earlier approved and marketed.

India's regulatory agencies and drug companies based their safety assessments on Data derived from long-term drug use in US, EUROPEAN and JAPANESE markets.

India did not have a formal Pharmacovigilance system in the past to detect adverse reactions of marketed drugs as very few new drugs were discovered in India and hardly any new drug was launched for the first time.

It was on November 23 2004, The CDSCO launched a formal National Pharmacovigilance Programme(NPP) and NPP became functional from January 1, 2005.

FOR MORE INFORMATION ABOUT NPP CONTACT

The National Pharmacovigilance Centre
Office of Drugs Controller General of India,
Central Drugs Standard Control Organisation,
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 website: www.cdsco.nic.in

Pharmacovigilance Centres Experiences

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