J&J scandal is India's wake-up call to reform rules for medical devices

The absence of compensation provisions in the Drugs & Cosmetics Act puts the spotlight on the gaps in the regulatory regime

The recent developments in the Johnson and Johnson (J&J) hip implant case have highlighted the gaps in the regulatory regime around medical devices in India. On November 29, the health ministry approved of a formula to determine the compensation to be paid by J&J to the patients who received “faulty articular surface replacement (ASR) hip implants manufactured by DePuy International, UK”. This led to the company approaching the Delhi High Court over the applicability of such an order of the government, in the absence of specific statutory norms to the effect. This has thrown up several legal issues, including the