With a report on flawed clearance of medical devices and implants garnering global attention, patient groups have sought stricter foreign regulatory nods for such products before their entry into the Indian market. Citing the case of Johnson & Johnson, involving faulty implants, the groups say India should not blindly rely on foreign approvals to medical products as it has no information system for patients in case of a device failure. The report has triggered concerns in India as FDA-approved devices don't need any clinical trials in the country. According to Malini Aisola, health researcher, co-convenor of the All India Drug Action Network, the US government constantly monitors cases involving medical products, while no such mechanism exist in India. We need urgent reforms for patient safety, including- abolishing the blind reliance on regulatory approvals of the US, EU etc.

Source: dna May 06, 2019 23:48 UTC