Sale of coronary stent only after submission of adequate supporting clinical studies: Delhi HC seeks Centre stand on plea
"At present cardiac stents/ coronary stents are allowed to be manufactured/imported and sold, without or with negligible supporting clinical study and data, and merely based on predicate (device/literature), submitted by the manufacturer/importer," the plea filed through lawyer Tushar Singh said.;
Delhi High Court
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New Delhi: The Delhi High Court on Tuesday sought the stand of the Centre on a plea seeking sale and marketing of coronary stents in the country only after submission of adequate supporting clinical studies. A bench of Chief Justice Satish Chandra Sharma and Subramonium Prasad issued notice to the Centre and the National Pharmaceutical Pricing Authority (NPPA) on a public interest litigation by Mayank Kshirsagar.
The petitioner, an advocate, said in his plea that currently cardiac stents are allowed to be manufactured, imported and sold "without or with negligible supporting clinical study" and, in the interest of public health, the Centre should develop a robust mechanism for approval of these devices similar to Food & Drugs Administration in the US.
The petitioner prayed for a direction to the Centre to "evolve and enforce a robust system of requirement of supporting clinical study and data and scrutiny/investigation of the same, prior to grant of approval for marketing/sale and use in India, of cardiac stents/coronary stents by manufacturers/importers."
Read also: Coronary stents now included in NLEM 2022
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