There is no distinction at present between the regulatory treatment of drugs and medical devices. Following the faulty hip implant case involving Johnson and Johnson, Niti Aayog proposed a legislation for medical devices and an independent regulator for the industry.
The health ministry, according to sources, has concerns. As the custodian of the Drugs and Cosmetics Act and the drug regulatory authority, the ministry has asked the Aayog to have wider consultations with the stakeholders.
“Are we saying that the existing Act is not sufficient to regulate medical devices? Tomorrow there could be a demand to have a separate law for regulating cosmetics. Are we going to have a separate law for cosmetics then?” questioned a ministry official.
While Niti Aayog’s Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 is not in the public domain yet, the think tank met senior officials of the health ministry, department of pharmaceuticals and Department of Industrial Policy and Promotions (DIPP) this month on the proposed legislation.
“Consultations would enable the think tank to form a broad consensus on the proposed Act. We are of the opinion that the stakeholders, including manufacturers, should be consulted and asked if there is a need for a separate Act and a regulator,” said another official.
Both drugs and medical devices are at present regulated by the Central Drugs Standard Control Organisation under the health ministry. The ministry in October issued a notification to regulate all medical devices from December 1.
According to the draft accessed by ET, the government will, by notification, establish an administration under the Directorate General of Health Services (DGHS), to be called the Medical Devices Administration. “There is no country in the world with separate regulators and laws for medicines and medical devices. If a road map has been prepared by the health ministry then what is the purpose of a new law?” the second official said.
The Aayog said the need to have a strengthened regulation was spelt out in the National Health Policy 2017, said a senior executive.
Under the proposed regulatory framework, patients suffering because of faulty medical devices and implants will also be able to demand compensation from manufacturer or importer of the device.
Read More News on
Download The Economic Times News App to get Daily Market Updates & Live Business News.