Last Updated on January 14, 2023 by The Health Master
New Delhi: The Delhi High Court sought the stand of the Centre on a plea seeking the 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 Subramonium Prasad issued notice to the Centre and the National Pharmaceutical Pricing Authority (NPPA) on a public interest litigation by Mayank Kshirsagar.
The petitioner, an advocate, said in his plea that currently cardiac stents are allowed to be manufactured, imported, and sold “without or with negligible supporting clinical study” and, in the interest of public health, the Centre should develop a robust mechanism for approval of these devices similar to the Food & Drug Administration in the US.
The petitioner prayed for a direction to the Centre to “evolve and enforce a robust system of requirements of supporting clinical study and data and scrutiny/investigation of the same, prior to grant of approval for marketing/sale and use in India, of cardiac stents/coronary stents by manufacturers/importers.”
The plea highlighted that cardiovascular diseases accounted for 1.79 crore deaths in 2019 in India, out of which 1.52 crore people died of heart attack and stroke, and adequate access to appropriate drug-eluting stents (DES) is essential to save lives.
“At present, cardiac stents and coronary stents are allowed to be manufactured, imported, and sold, without or with negligible supporting clinical studies and data, and merely based on the predicate (device or literature), as submitted by the manufacturer/importer,” the plea filed through lawyer Tushar Singh said.
“The literature required to be submitted for consideration by the Respondent No.1 (Ministry of Chemicals & Fertilizers) for approval of a new cardiac stent or coronary stent is required to contain only limited clinical study data… due to which a large number of low- or poor quality cardiac stents/coronary stents are available in India, posing immense health risks to Indian patients,” it stated.
The plea also said that while the petitioner is not challenging the price fixation of coronary stents by the Centre, he is seeking a “rational methodology to fix the ceiling price to ensure that advanced DES are available to common man or patient.”
“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,” it said.
The plea said the right to life under Article 21 of the Constitution of India includes the right to all reasonable health facilities. The matter will be heard next in May.
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Medical Device Testing Laboratories (MDTLs)
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
FAQs – on Blood Bags and its Testing
NABL 126: Specific criteria for calibration of Medical Devices
USFDA gives approval for Prasugrel tablets
IPC publishes draft monograph revision proposals
High demand for Indian generic drugs in China
NPPA may fix retail price of drugs under phase IV Clinical trials
Govt Job: For the post of Director at CDTL, CDSCO
List of approved FDCs (Fixed Dose Combinations) Updated
List of approved New Drugs Updated
NPPA extends ceiling price of LMO, Oxygen Inhalation
Drug licences of these two firms suspended: FDA Manipur
Fake pharma firm busted, two arrested
Latest Notifications regarding Pharmaceutical
For informative videos on Medical Devices, click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
