The shortcomings of the Drugs and Cosmetics Act, 1940 exposed a toothless regulatory framework for medical devices. The executive cannot create new offences or penalties through its rule-making authority. Only laws enacted by Parliament can create new offences and penalties. As a result, the Medical Device Rules, 2017 contain no penal provisions. The legally binding standards recognized under the Second Schedule to the 1940 Act covers only pharmacopoeias for drugs, and no standards for medical devices, and therefore, no prosecution of a manufacturer of sub-standard medical devices.
There are no tools available to Indian regulators under the framework to hold makers of sub-standard medical device manufacturers to account for their actions. At most, the Health Ministry can prohibit the manufacture and sale of certain medical devices under Section 26A or cancel a license to prevent further harm.
In the J&J case, the manufacturer sold devices to doctors and hospitals instead of patients directly, so it did not have a list of patients who had these devices implanted. Doctors and hospitals lack incentives to share the patient list and even if they want to, legal liability for surgically faulty devices in the patient’s body would stop them from doing so.
Source: Barandbench
