The Union Health Ministry has notified the inclusion of coronary stents in the National List of Essential Medicines, 2022, a move that will help make these life-saving medical devices more affordable.
The move is based on the recommendations of an expert committee constituted to review the inclusion of stents in the list based on needs.
The National Pharmaceutical Pricing Authority (NPPA) will now fix the price of coronary stents.
On November 6, the Standing National Committee on Medicines (SNCM) submitted its recommendation for inclusion of Coronary Stents in the National List of Essential Medicines (NLEM), 2022 in two categories – Bare Metal Stents (BMS) and Drug Eluting Stents. DES) including metallic DES and bioresorbable vascular scaffolds (VBS)/biodegradable stents.
According to the minutes of the SNCM meeting, Vice Chairman Dr YK Gupta said that coronary stents were earlier included in NLEM, 2015 through a separate notification based on the recommendations of an expert committee.
“As far as drugs are concerned, the SNCM has already submitted its report on NLEM, 2022 and it has been accepted by the government,” said an official source.
The SNCM deliberated upon the imperative, classification and other relevant aspects of Coronary Stents.
It is also stated that coronary artery disease (CAD) is a public health issue associated with high morbidity and mortality. There is a high need for percutaneous coronary intervention requiring implantation of a coronary stent.
Therefore, coronary stents should remain essential medical devices, the committee members agreed.
“After considering all the aspects of Coronary Stent, the Committee recommended that Coronary Stent is an essential medical device notified as a ‘drug’ under the Drugs and Cosmetics Act, 1940 and hence, it may be notified under the NLEM, 2022 should be included,” said an official.
He said that for the purpose of NLEM in respect of coronary stents, the authorities should separately consider various coronary stents under the categories of bare metal stents and drug eluting stents.
The members said that the Indian Council of Medical Research and other concerned institutions may also consider taking necessary initiatives to generate data for post-marketing safety and performance assessment of coronary stents being used in various hospitals/institutions.
“Following the recommendations of the expert committee, the Union Health Ministry has notified the inclusion of Coronary Stents in the National List of Essential Medicines (NLEM), 2022,” the official said.
The National List of Essential Medicines released on September 13 saw 34 new additions, including several anti-cancer drugs, antibiotics and vaccines, taking the total number of drugs under it to 384.
