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.
The report claims 80,000 deaths and 20 lakh injuries in the last decade in the US alone. 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.
After the US Food and Drug Association said last month that there was no guarantee for the long-term safety of the ‘vaginal mesh’ products, which have existed for decades and are implanted to hold pelvic organs to reinforce the weakened vaginal wall, investigations showed that the synthetic nettings alone have caused 80 deaths till 2018 and over 1 million claims, said a report by the New York Times.
The report has triggered concerns in India as FDA-approved devices don’t need any clinical trials in the country. “In India if a product is registered in the US or Europe, there is no need to conduct clinical trials in India but if no predicate is available in the US or European market, clinical trials are required,” reads an article published in the ‘International Journal of Drug Regulatory Affairs’ on Medical devices and their approval procedure in India.
The best example for the need for stricter laws in India on the import of medical devices is the Johnson & Johnson hip implants, where of the 4,700 surgeries involving faulty Articular Surface Replacement hip implants, only 1,000 patients have been traced so far.
The groups say over 66 per cent with faulty ASR had been reached out in the US within a year and the number remained less than one per cent in its first year of fault detection in India.
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. She said, “Once a person is implanted with a faulty device, we may not have a way to reach out. We need urgent reforms for patient safety, including- abolishing the blind reliance on regulatory approvals of the US, EU etc. for granting licences in India.” – DNA India