PIL in Delhi HC against approval mechanism for heart stents, notice issued

New Delhi [India], January 10 (ANI): The Delhi High Court on Tuesday issued notice on a Public Interest Litigation (PIL) seeking direction to the Ministry of Health and Family Welfare to evolve and enforce a robust system of requirements of supporting clinical study and scrutiny of the same, prior to the grant of approval for marketing or sale and use in India, of cardiac stents or coronary stents by manufacturers and importers.

The plea stated that at present cardiac stents or coronary stents are allowed to be manufactured or imported and sold, without or with negligible supporting clinical study or data, and merely based on predicate (device or literature), submitted by the manufacturer or importer.

The Bench of Justice Satish Chander Sharma and Justice Subramonium Prasad on Tuesday sought a response of the Ministry of Health and Family Welfare and National Pharmaceuticals Pricing Authority, Department of Pharmaceuticals and fixed the matter for May 10, 2023.

The petitioner Mayank Kshirsagar, a practising lawyer and also on the Editorial Board of Medical Law Cases further seeks issuance of direction to the Department of Pharmaceuticals and National Pharmaceuticals Pricing Authority to consider whether cardiac or coronary drug-eluting stents (DES) ought to be classified into two or more categories based on indications as approved in India and supported by clinical studies/data proposed and accordingly fix separate Ceiling Price for each category of DES.

Petitioner further submitted that the Ministry of Health ought to develop a robust mechanism for the approval of devices including Stents, similar to the Food & Drugs Administration, USA (FDA).

“For the approval of a medical device including Stents for sale, FDA requires a critical, large and randomized study, which are monitored during the span of several years and the medical device is required to demonstrate delivery of stated benefits without any side effects and not merely ensuring that the patient survives post-surgery,” the plea stated.

The plea further stated that the Department of Pharmaceuticals and National Pharmaceuticals Pricing Authority 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 the withdrawal of advanced DES brands from India, denying adequate access of appropriate DES to patients, who have a specific medical condition like diabetes, higher bleed risk, calcified blockage, long blockage, left main disease, multiple blockages amongst others.

Fixing of a common Ceiling Price fixed for all DES by the Respondents would cause
the unavailability of technologically advanced DES in India that are available elsewhere in the world (especially GHTF countries like Australia, Canada, Japan, the European Union, and the United States), thereby denying advanced and technologically improved DES being available to patients in India, plea read.