FROM PLUGGING loopholes in India’s regulatory framework for medical devices to safety of patients, pricing and restrictions on import of pre-owned equipment, the new National Medical Devices Promotion Council (NMDPC) set up by the central government is finalising key issues to take up in its first meeting slated to be held soon.
The council was set up on December 7, days after The Indian Express published the Implant Files, a series of investigative reports on the big, medical bazaar where devices are advertised, sold, and surgically implanted across the world under regulatory systems riddled with holes.
The council will operate under the Ministry of Commerce and Industry, and will have 14 members, including representatives from the Health Ministry and Niti Aayog.
“We intend to table six items on the agenda related to the medical device regulatory framework. They will include trade margin rationalisation to protect consumers from exorbitant pricing and restrictions on import of second-hand medical equipment till we have robust regulations to ensure calibration and patient safety,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AIMED), who has been nominated to the council.
The council is also expected to discuss the findings of the 10-month-long investigation by The Indian Express.
The investigation, in association with the International Consortium of Investigative Journalists (ICIJ), found that global pharma majors are pushing these devices — from coronary stents and pacemakers to breast and knee implants — into markets via a dubious nexus with hospitals and doctors.
It found breast implants being done in basement Operating Theatres; an out-patient department at AIIMS to conduct revision surgeries for faulty orthopaedic implants; and global majors, such as Johnson & Johnson, Medtronic, Stryker, Abbott and Bayer, pushing devices without adequate oversight for quality or clinical testing.
The investigation also revealed that more than half of the medical and diagnostic medical equipment used in private clinics and hospitals are imported as “pre-owned” or “second hand” with no assessments done on their levels of accuracy or safety.
“The council will start functioning any day now. We are working on a set of agenda points that will be discussed extensively in the first meeting. We have also issued letters to the ministries concerned to send the names of their representatives,” said a senior official.
According to Nath, the AIMED will propose discussions on “nominal tariff protection” for medical devices and a Health Ministry facility to issue free sales certificates for medical devices, including those not notified as drugs, for enabling exports.
“We had been raising these issues with the Department of Pharmaceuticals. But these requests require inter-ministry coordination, and it has been a challenge. But now, with the establishment of the council, all key departments will be represented for enabling joint decision-making on issues related to medical devices,” Nath said.
According to the government, the NMDPC will facilitate, promote and develop the medical device industry. It will identify redundant processes and render technical assistance to agencies and departments to simplify the approval processes.