Regulating medical devices

The government’s move to regulate medical devices by notifying them all as drugs and bringing them under the purview of the Drugs and Cosmetics Act is a positive step as it is aimed at meeting certain standards of quality and efficacy in these products. The tightened regulation addresses the vacuum felt in the aftermath of Johnson & Johnson’s faulty hip implants. Concerns about patient safety and gaps in the accountability of medical device manufacturers as well as doctors arose last year when J&J had had to recall the devices in India after global reports of metal poisoning and high failure rate.

In the absence of norms regarding the quality of a device, doctors shy away from trying products of new companies. With the devices now coming under the lens of the Central Drugs Standard Control Organisation (CDSCO), the domestic medical device industry, that is estimated to be worth billions of rupees, stands to gain. However, the department needs to allay apprehensions regarding not only its ability and competence to ensure excellence, but also of slipping into inspector raj. The argument that medical devices, ranging from the comparatively low-risk contraceptives, cotton swabs and thermometers to high-tech implants and radio-diagnosis machines, are engineering items — and not drugs — is logical. The challenge lies in bringing about clear regulatory rules in dealing with the matter at hand; they cannot be the same for such a complex range of micro and macro devices. The new regime is likely to shake up local small-scale firms as compliance with standards may prove too costly for them.

While the government’s intention of bringing the devices under scrutiny is good and in keeping with the best practices in the world, the half-baked rules need to be worked upon. Their implementation will be a test for the CDSCO that sadly is accused of collusion with medical experts and pharmaceutical companies. Its commitment towards patient safety must not be compromised. Unregulated devices can play havoc with the patient’s diagnosis and treatment.

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