In India, a side-effect report becomes a safety signal only after our pharmacovigilance team reviews many such reports and finds a pattern, linking it to our drug specifically. Most reactions go unreported because patients in small towns often just stop the medicine and tell the chemist, and it never reaches us. From my desk, I see how these gaps happen — our field staff tries, but a farmer in my own village won't call a toll-free number for a headache he thinks is normal. So, the safety signal depends on who feels their voice matters enough to report.
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