The faulty Johnson and Johnson (J&J) articular surface replacement (ASR) hip implants case, which caused distress to thousands of patients in India, highlights the need for a separate regulatory authority for medical devices in the country, says GlobalData, a leading data and analytics company.
Reportedly, DePuy International, a Johnson & Johnson subsidiary, had informed the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, in 2010 that about 1,295 of the total 15,829 ASR implants imported in India were recalled.
However, it took seven years for the Indian government to form an expert committee to examine the issues arising out of faulty hip implants in the country. The details revealed by the expert committee were alarming. In addition, about 3,600 of the 4,700 patients who received DePuy’s hip implants could not be traced.
Vishnu Bhargav, Medical Device Analyst at GlobalData, says: “Lack of immediate action from the regulatory body as well as failure to maintain a national registry of users made it difficult to track patients.”
GlobalData forecasts the hip reconstruction market in India to increase from around US$90m in 2018 to nearly US$160m by 2025 due to the rise in the number of hip fractures, a surge in the diseased arthritis population as well as affordability and accessibility to the procedures.
Bhargav concludes: “The absence of a comprehensive regulatory framework for medical devices and the non-existence of strong compensation provisions for the affected patients of faulty implants may hinder the growth of the hip reconstruction market in India.
“Currently, CDSCO is the only regulatory body for both pharmaceuticals and medical devices in India. Medical devices are different from drugs and the government needs to establish a separate regulatory body to ensure patient safety and address regulatory inadequacies, and set up an independent national registry to track the usage of high-risk medical devices.”