The Delhi High Court on Tuesday asked the central government to respond to 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 Justice Subramonium Prasad also issued notice to the National Pharmaceutical Pricing Authority (NPPA) over the plea. The case will be heard again in May.
In his petition, advocate Mayank Kshirsagar stated that cardiac stents are currently allowed to be manufactured, imported, and sold “without or with negligible supporting clinical study”.
The plea said that the Centre should develop a robust mechanism for approval of these devices similar to the Food & Drugs Administration (FDA) in the United States.
It added that cardiovascular diseases accounted for 1.79 crore deaths in 2019 in India, of which 1.52 crore people died of heart attack and stroke.
The petitioner clarified that he was not challenging the price fixation of coronary stents by the Centre, but seeking a “rational methodology to fix the ceiling price to ensure that advanced drug-eluting stents (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,” the plea noted.
