Coronary stents now included in NLEM 2022

The move is based on the recommendations by an expert committee constituted to review the inclusion of stents in the list based on the requirement.

The National Pharmaceutical Pricing Authority (NPPA) will now fix the price of coronary stents. On November 6, the Standing National Committee on Medicines (SNCM) had submitted its recommendation for the 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) which include metallic DES and bioresorbable vascular scaffold (VBS)/biodegradable stents.

According to minutes of the SNCM meeting, vice chairman Dr Y K Gupta stated that coronary stents were earlier included in NLEM, 2015, through a separate notification based on the recommendations of an expert committee.

"As far as medicines are concerned, SNCM has already submitted its report on NLEM, 2022, and the same has been adopted by the government," an official source said.

The SNCM had deliberated on the essentiality, categorisation, and other relevant aspects of coronary stents. It also stated that coronary artery diseases (CAD) are a public health issue that is associated with high morbidity and mortality. There is an enormous need for percutaneous coronary interventions requiring the implantation of coronary stents. Therefore, coronary stents should continue to be essential medical devices, committee members agreed.

"After taking into consideration all aspects of coronary stents, the committee recommended that coronary stent is an essential medical device which has been notified as a 'drug' under the Drugs and Cosmetics Act, 1940 and therefore, it should be included in NLEM, 2022," an official said.

Authorities for the purpose of NLEM in respect of coronary stents should consider various coronary stents separately under the categories of Bare Metal Stents and Drug Eluting Stents, he said.

The Indian Council of Medical Research and other relevant institutions may also consider to take necessary initiatives to generate data for assessment of post marketing safety and performance of coronary stents being used in various hospitals/institutions, the members stated.

"Following the recommendations by 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 added. Several anti-cancer drugs, antibiotics, and vaccines were among 34 new additions to the National List of Essential Medicines released on September 13, taking the total number of drugs under it to 384.

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