Delhi High Court Issues Notice On PIL Seeking Requirement Of Clinical Study For Approval Of Coronary Stents

The Delhi High Court on Tuesday issued notice on a public interest litigation seeking enforcement of a robust system of requirement of submitting a clinical study or data before grant of approval for marketing, sale and use of drugs for coronary stents.

A division bench of Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad sought response from the Centre through the Ministry of Health & Family Welfare and the National Pharmaceuticals Pricing Authority.

The plea submits that at present "cardiac/coronary stents" are allowed to be manufactured or imported and sold without or with negligible supporting clinical study or data and merely on the basis of the literature submitted by the manufacturer or importer.

Moved by Advocate Mayank Kshirsagar, the plea also wants authorities to consider whether coronary drug eluting stents (DES) ought to be classified into two or more categories. It accordingly seeks fixing of separate ceiling price for them.

The petitioner lawyer has appreciated the decision of authorities in fixing the ceiling price for Basic Metal Stents (BMS) and DES at Rs. 7,260 and Rs. 29,600 respectively, adding that the coronary stents were earlier available between Rs. 40,000 and Rs. 1,00,000.

However, the plea avers that bundling a wide range of drug eluting stents in a single category and fixing a single uniform ceiling price for all of them has resulted in withdrawal of advanced DES brands from India, denying adequate access of to patients who have specific medical conditions like diabetes, higher bleed risk, calcified blockage, long blockage etc.

“Because of the common Ceiling Price fixed for all DES by the Respondent No.3, technological advanced DES that are available elsewhere in the world (especially GHTF countries like Australia, Canada, Japan, the European Union, and the United States) have not been made available/introduced in India, thereby denying advanced & technologically improved DES being available to patients in India,” the plea submits.

Title: Mayank Kshirsagar v. Union of India & Ors.