The Supreme Court will hear on unregulated medical devices tomorrow, ANI reports.
Justice N. V. Ramana will head a bench to hear a public interest litigation (PIL) filed by Dr Rohit Jain seeking government action on online sale of medical devices – specifically glucometers and in vitro diagnostic medical devices. Unregulated medical devices, the suit contends, are widely available online and action is needed to prevent them from falling into the hands of individuals who lack the requisite licensure, authorisation, or qualification to operate them on behalf of patients.
“Ordinary people are forced to go to the illegal and unauthorisedly running diagnostic laboratories which are producing lab reports with [the] help of uncalibrated testing equipment,” the PIL reads. It states “it is the need of the hour to formulate a comprehensive guideline to regulate the medical devices being used for generating a clinical report to ascertain its authenticity for proper and accurate treatment.”
The hearing on unregulated medical devices comes at a time when the regulation of such implements is making headlines as the Union Ministry of Health and Family Welfare plans to enact a new regulatory framework for medical devices. They will now be brought under the purview of the Central Drugs Standards Control Organisation (CDSCO) and regulated as ‘drugs’, bringing them within the ambit of the Drugs and Cosmetics Act, 1940 in what has been – in part – a controversial proposal.
The existence of a relatively open market of unregulated medical devices can be hazardous to the health and treatment outcomes of patients and embolden and enable India’s legion of quack doctors. As such, the hearing before the Supreme Court is an encouraging move – as is the broader national discussion over the need to ensure that medical devices are properly regulated and licensed with a view towards guaranteeing efficacy, quality, transparency, and safety.