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 plea highlighted that cardiovascular diseases accounted for 1.79 crore deaths in 2019 in India, out of which 1.52 crore people died of heart attack and stroke, and adequate access to appropriate drug-eluting stents (DES) is essential to save lives. “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.
The plea said the right to life under Article 21 of the Constitution of India includes the right to all reasonable health facilities.