Production of medical devices and equipments is a crucial component of healthcare industry and it is growing with increasing complexity. The quality standards and efficacy of these products are considered as critical as drugs because the use of any defective medical devices could lead to serious complications or infections in patients. There were 30 cases of infections amongst patients in Johns Hopkins as latest as 2001 after the use of a group of defective bronchoscopes. It is surprising that such instances could occur in the US where stringent regulations on the manufacture and marketing of these products are already in place. In most of the developing countries including in India, an effective regulatory system for medical devices and equipments does not exist despite its increasing use. In India, there has been no comprehensive set of Central regulations governing the manufacture and quality standards of these products. The only Central regulatory authority for some major medical equipments like X-ray machines, CT scan, etc is Atomic Energy Regulatory Board which also has many other non medical functions. Barring these, manufacture and marketing most of the medical devices and equipments used in the country remain largely unregulated. However, some state drug authorities do have a system of licensing for certain groups of medical devices but with no specifications of standards and monitoring of quality.
The proposal by the Centre, in this context, to set up Indian Medical Devices Regulatory Authority, an independent and self-sustaining body for certifying and monitoring these products is indeed a brilliant initiative. The draft proposal, made by the Society for Biomedical Technology, is of the view that such a body can effectively handle the administration of medical devices without creation of a big infrastructure. The first responsibility of IMDRA should be to make a registry of products and product groups of all medical devices and equipments available in the market. Currently, no such list of products is available with any government department. Preparation of a detailed document based on the registry with the current standards for each item, certification of testing laboratories for QC, pre market certification, surveillance and notification, enforcement, post-marketing follow up, regulating import of devices, recall of products, periodic review of procedures, etc. will be some of the vital functions of this new authority. A key challenge and responsibility of IMDRA will be how effectively it will be able to recall defective medical devices from the market. A large number of medical devices currently available in the market are defective and substandard. It is also possible that once marketing permission is granted for a new product, manufacturing units could bring down the quality for cutting costs. In situations like this IMDRA cannot just rely on manufacturers to take the full responsibility for product recalls once the defects are established. Physicians practicing in thousands of hospitals, nursing homes and clinics across the country may usually remain unaware of the recall of a particular device by the regulatory authorities unless it is adequately publicised.