Sale of coronary stent only after submission of adequate supporting clinical studies: Delhi HC seeks Centre stand on plea

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."

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 literature required to be submitted for consideration by the Respondent No.1 (Ministry of Chemicals & Fertilizers) for approval of a new cardiac stents/coronary stents is required to contain only limited clinical study data... due to which a large number of low/poor quality cardiac stents/coronary stents are available in India, posing immense health risk to Indian patients," it stated.

The plea also said that while the petitioner is not challenging the price fixation of coronary stents by the Centre, he is seeking a "rational methodology to fix the ceiling price to ensure that advanced DES are available to common man/patients".

"The Respondent Nos. 1 and 3 (NPPA) have erroneously bundled a wide range of DES in a single category and thereby fixing a single uniform ceiling price for all Coronary DES which would eventually result in withdrawal of advanced DES brands from India, denying adequate access of appropriate DES to patients, who have specific medical condition like diabetes, higher bleed risk, calcified blockage, long blockage, left main disease, multiple blockages amongst others," it said.

The plea said the right to life under Article 21 of the Constitution of India includes the right to all reasonable health facilities. The matter will be heard next in May.