NEW DELHI: The High Court on Tuesday sought the response of the Centre on a plea demanding a mechanism to examine clinical studies and data before a cardiac or coronary stent is approved for general use.
Issuing notice to the Centre, department of pharmaceuticals and National Pharmaceuticals Pricing Authority (NPPA) on the PIL, a division bench of Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad posted the matter for May 10.
The plea, filed through advocate Tushar Singh and argued by advocate Jawahar Lal, contended that, at present cardiac stents are allowed to be manufactured, imported and sold, without or with negligible
supporting clinical study data, and merely based on predicate device or literature, submitted by the manufacturer.
The petitioner sought the Ministry of Health and Family Welfare to develop a robust mechanism for approval of devices including stents, similar to Food & Drugs Administration (FDA), United States.
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 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.
As per the plea, currently, the ministry is conducting a six-month study on 100 people is considered sufficient to determine patient safety. “On the contrary, the minimum sample for a clinical study by the FDA for stent is upto 2,200 patients, depending on the end point, and it can be upto 5,000 patients for 5 years.
The FDA does not even consider a 6-month study and 100 people study, and the minimum requirement is one year study, followed by two year and five years follow up study (known as Post Marketing Study in India),” the plea stated.
It also said that bundling a wide range of Drug-eluting stents (DES) in a single category and fixing a single uniform ceiling price for all Coronary DES resulted 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.