Discussions with the central government on price regulation of coronary stents — used in treating certain cardiac conditions — has been positive leading to consensus on implementing a scoring matrix for the drug eluting stents (DES), the Healthcare Federation of India (Nathealth) has said.
The industry body, which represents the top Indian and international health care companies, and medical technology, health insurance, health IT and start-ups in the country, has been raising objections to the recent decision of the ministry of health and family welfare to add coronary stents to the National List of Essential Medicines (NLEM) 2015, following which the next move would be bringing the product under price control.
Besides, a report of the ministry has indicated its desire to bring other cardiology products under NLEM as well. The organisation opposes the move, pointing out that medical devices can’t be treated through policies and frameworks made completely for pharmaceutical products.
In a meeting held last week between officials of the department of pharmaceuticals, National Pharmaceutical Pricing Authority (NPPA), Nathealth and other stakeholders, all aspects related to the pricing of the stents were discussed. Nathealth officials said the government was soon expected to come out with a policy related to this.
During the meeting, clinicians and experts asked the government that a DES classification norm through a matrix be prepared after a detailed workshop deliberating on all the relevant criteria like type of drug, type of alloy, strut thickness, polymer profile, deliverability and trackability, among others.
The industry body, which represents the top Indian and international health care companies, and medical technology, health insurance, health IT and start-ups in the country, has been raising objections to the recent decision of the ministry of health and family welfare to add coronary stents to the National List of Essential Medicines (NLEM) 2015, following which the next move would be bringing the product under price control.
Besides, a report of the ministry has indicated its desire to bring other cardiology products under NLEM as well. The organisation opposes the move, pointing out that medical devices can’t be treated through policies and frameworks made completely for pharmaceutical products.
In a meeting held last week between officials of the department of pharmaceuticals, National Pharmaceutical Pricing Authority (NPPA), Nathealth and other stakeholders, all aspects related to the pricing of the stents were discussed. Nathealth officials said the government was soon expected to come out with a policy related to this.
During the meeting, clinicians and experts asked the government that a DES classification norm through a matrix be prepared after a detailed workshop deliberating on all the relevant criteria like type of drug, type of alloy, strut thickness, polymer profile, deliverability and trackability, among others.
"There seems to be a consensus amongst Clinicians, Government and Industry that a Scoring Matrix, with above parameters, should be designed to determine the DES classification and NATHEALTH sincerely requests the Government to follow up through a multi-stakeholder workshop to design the matrix," said Anjan Bose, secretary general, NATHEALTH.
He earlier said that the decision to include stents under the NLEM has created apprehension among the foreign medical devices companies on investing in India. The industry has been concerned about the policy approach, rather than the size of the stent market in the country.
The Medical Technology and other healthcare sectors also recommended that the government allows differential pricing for discrete generation stents as the new generation stents are believed to have better long-term patient-centric outcomes like low thrombosis and low re-stenosis rates.
It may be noted that the medical devices industry has raised concerns almost a decade back when the the centre took steps to include Cardiac Stents and DES notified as 'drugs' under section 3, clause (b) (iv), of the Drugs and Cosmetics Act & the Rules.