The govt has constituted a core committee which will start deliberations on a 'war footing' to include essential medical devices under the ambit of a National List
New Delhi: After slashing prices of coronary stents and knee implants, the government is considering capping prices of more medical devices deemed essential in health care centres to improve their affordability and accessibility—a move that is expected to hit the medical device industry.
The government has constituted a core committee which will start deliberations on a “war footing" to include essential devices under the ambit of a National List of Essential Medical Devices (NLEMD). The devices are intended to be available within health care systems with assured quality and at an affordable price.
“The devices and medical equipment included under the list will be those which are required for the basic running of medical premises including hospitals, clinics and those required to handle medical emergency," according to a government document reviewed by Mint.
The Central Drugs Standard Control Organisation (CDSCO), the regulatory body for pharmaceuticals and medical devices, which constituted the core committee for the preparation of the NLEMD in August, under directions from the ministry of health and family welfare, has mandated the committee to shortlist medical devices and essential equipment to meet the common contemporary health needs of the country.
“It is pertinent to mention that the medical devices and essential equipments included in the list should have all the devices that are adequate to meet the general obligation of the health administrator to ensure abundant availability of such medical devices and equipments in the country," the document further adds.
Along with the list of devices to be included in NLEMD, the committee is also expected to draw up detailed guidelines and procedures for the preparation of the NLEMD and suggest ways and measures to provide use of medical devices for preventive care.
To ensure that the report is submitted on time, the government has sought the consent of committee members to “spare their time for preparing the report on war footing basis". The panel is expected to submit the report within six months from the date of its first meeting.
The Drug Controller General of India (DCGI) has asked the committee members to take the views of stakeholders including civil society, manufacturing associations and individual industry experts by organising brain storming workshops in different parts of the country before it finalises the list.
Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), said that the move was disadvantageous for the growth of industries manufacturing medical devices. “The issue of affordable access to medical devices needs to be treated differently and holistically. We are against the concept of item by item coverage of specific medical devices and then trying to define them as essential so that they can have a price cap," he said.
“The government had even sought a list of essential and life saving devices from us but it is difficult to define what is life saving and what is not. We have been recommending the government that for the devices already notified as drugs, the government can consider to put a price cap of 3-4 times the import landed price, and for the ones which are not notified as drugs, the government may consider to bring in tax-based disincentives so that manufacturers and importers are discouraged to print excessive MRP on their product labels," he said.
Nath said that the government should help the stakeholders to self regulate before considering a possible mandatory measure of price cap that could kill the industry.
At present, India has a National List of Essential Medicines (NLEM) published by the central government, which sets maximum limits on drug prices for essential medicines and some devices. NLEM comprises drugs that are listed after considering the disease burden, efficacy, safety, and comparative cost-effectiveness of the medicines. While medicines and devices listed in NLEM are required to be sold at the price fixed by the National Pharmaceutical Pricing Authority (NPPA), those in the non-scheduled list are allowed a maximum annual price hike of 10%. Drugs outside price control can be sold at prices set by the manufacturer.
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