Law of the land can help or destroy the Pharmacovigilance system
Posted Mar 24 2011 9:25am
U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects.
Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No
Compare that to the Indian Law System
Madras High Court in India allowed a stay on immediate withdrawal of drugs banned due to Severe Side Effects. The pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries put revenue loss to industry above safety of patients & managed to get a reversal of the ban.