Source:
livemint.com/Wall Street JournalPosted: Sun, Jul 27 2008. 11:59 PM IST
No adverse reactions to any drugs reported from 2005-07; govt concedes drug makers aren’t reporting either
New Delhi: India has not reported a single instance of medicinal side effects from drugs for the last three years to an international drug monitoring database set up by the World Health Organization (WHO).
Some industry observers see this as evidence of India’s lax monitoring of so-called adverse drug reactions, or ADRs, in patients, or pharmacovigilance.
Such adverse reactions are believed to be the fourth largest cause of mortality and morbidity globally.
Drugs typically throw up newer side effects than were known during clinical trials once they begin to be administered across large groups of patients. Collecting this data is crucial for patient safety as well as fine-tuning medical research.
The database of Sweden-based Uppsala Monitoring Centre, which carries out WHO’s international drug monitoring programme, shows no ADRs were reported from India between 2005 and 2007, a near impossibility, say experts, given India’s population, and the massive number of medicines and combinations being introduced into the market.
“The system (of pharmacovigilance) has failed in India. There is lack of training, medical assessors in drug controller’s office, insufficient funds and no motivation at all,” says Pipasha Biswas, managing director of Symogen Ltd, an outsourcing services company with operations in the UK and India that focuses on pharmacovigilance-related se-rvices.
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http://www.livemint.com/2008/07/27235945/India-fails-to-report-drug-sid.html
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