Delhi HC seeks Centre's response on plea for perusing clinical data before approving stents

New Delhi, Jan 10 The Delhi High Court on Tuesday issued notice to the Centre, through the National Pharmaceuticals Pricing Authority (NPPA) and Department of Pharmaceuticals, on a Public Interest LitIgation (PIL) demanding to enforce a robust system of requirement of supporting clinical study and data prior to grant of approval for use of cardiac stents or coronary stents in India.

A division bench of Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad was dealing with a petition filed by advocate Mayank Kshirsagar.

It listed the matter for next hearing on May 10.

Appearing for the Centre, Additional Solicitor General Chetan Sharma said that the issue raised is very important and the government will file its response on the matter.

"This is a cause of concern... This has a very wide impact and he is raising some substantial question. This needs to be sorted out."

The argument made in the petition was that coronary or cardiac stents are currently permitted to be produced, imported, and sold with little to no clinical research or data to support them. According to the argument, it is only based on the predicate (device/literature) that the maker or importer has submitted.

"For approval of a medical device including stents for sale, FDA requires a critical, large and randomised study, which are monitored during the span of several years (in general more than one year) 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 read.

The petitioner further sought that the government decide whether to divide the Drug Eluting Stents (DES) into two categories and then set the ceiling price in accordance.

The plea stated: "First basic DES which addresses common indications (conditions/ diseases) like symptomatic ischemic disease, de-novo blockages and (Second) advanced DES which addresses specialised indications/conditions/diseases such as diabetes, higher bleed risk, calcified blockage, long blockage, left main disease, multiple blockages amongst others, and accordingly, fix the ceiling price."

The plea further stated that although the petitioner is not contesting the government's choice to set a ceiling price for stents, the grouping of numerous DES under a single category and the imposition of a single uniform ceiling price has caused advanced DES brands to leave India.

"Because of the common ceiling price fixed for all DES by respondent No 3 (NPPA), technological advanced DES that are available elsewhere in the world have not been made available or introduced in India, thereby denying advanced and technologically improved DES being available to patients in India."

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