The Union health ministry has accepted the recommendations of an expert panel constituted to examine the issues relating to the essentiality of coronary stents and has decided to include coronary stents in the NLEM 2015 with immediate effect.
“The sub-committee has submitted its report to the government and after examination of the report, the government of India has accepted the recommendations of the sub-committee. The government has further decided that the recommendations of the sub-committee with regard to inclusion of the coronary stents in the NLEM 2015 will be operational with immediate effect,” the health ministry in its order said.
Earlier, the health ministry had constituted a Core Committee under the chairmanship of Dr VM Katoch, former secretary, Department of Health Research and director general, ICMR for reviewing and revising the National List of Essential Medicines (NLEM), 2011 in the context of the contemporary knowledge of the use of therapeutic products.
While the Core Committee was finalizing its recommendations, the Delhi High Court, in response to a public interest litigation filed before it seeking a direction to the government to include 'coronary stents' in the NLEM thereby controlling the sale of the same, issued an order dated 25.02.2015, to treat the petition as a representation and issue an appropriate order in accordance with the law. In view of the said Order, the health ministry constituted a sub-committee of the Core Committee under the chairmanship of Prof YK Gupta, Professor and Head, Department of Pharmacology, AIIMS, New Delhi to examine the issues relating to the essentiality of coronary stents.
After examining the issue, the sub-committee headed by Prof YK Gupta recommended to include coronary stents in the NLEM-2015.
Considering the high burden of coronal artery disease (CAD) in India which is associated with high morbidity and mortality, the coronary artery disease is a public health problem.
Percutaneous coronary intervention (PCI) And coronary artery bypass graft (CABG) are the important treatment modalities for the management of CAD (both stable coronary artery disease and patients with acute coronary syndrome). There is enormous need of PCI procedure requiring coronary stem implantation in India. Therefore, coronary stents are essential medical device. Although, medical devices are different from drugs in respect of their nature, mechanism of action, manufacturing, quality control, mode of administration/implantation, etc, coronary stents are among the categories of Medical Devices which have been notified by the government of India as “Drug'' under the provisions of the Drugs and Cosmetics Act, 1940. Therefore, the Committee recommends that the coronary stents should be included in the National List of Essential Medicines (NLEM) 2015, the sub-committee in its recommendations said.