A committee comprising representatives of medical device industry associations and senior members of the Health Ministry Friday decided to make ten key recommendations to the government, including a proposal to formulate a separate medical devices law.
The move comes two months after The Indian Express published the Implant Files, a series of investigative reports on the unregulated medical bazaar in India. The investigation, done in association with the International Consortium of Investigative Journalists (ICIJ), found that global pharma majors have been pushing medical devices — from coronary stents and pacemakers to breast and knee implants — into markets via a dubious nexus with hospitals and doctors.
Sources said the committee, at its very first meeting called by the Drug Controller General of India, decided to recommend revamp of the current medical devices regulator, Central Drugs Standard Control Organisation(CDSCO), and regulation of all medical devices — only 23 devices are currently notified by the government.
The other recommendations, sources said, are related to strengthening of the serious adverse event reporting mechanism. The committee, which will send its recommendations to the Ministry, wants the medical devices regulations rolled out in a “phased manner”, sources said.
Sources said the committee wants “registration of all manufacturers and importers of all non-notified medical” — where a “device label” will introduced — to ensure every medical device in the country can be traced.
It has decided to recommend that all the importers and manufacturers list their ISO13485 certifications — that deals with quality management system required for medical devices — from “accredited certification bodies like the National Accreditation Board for Certification Bodies (NABCB)”.
Rajiv Nath, Forum Coordinator, Association of India Medical Device Industry, told The Indian Express: “These two recommendations will have the most impact. This will create a new regulatory marketing approval system and the government will know who imports or manufacturers what type of a device. At present, the government has no data on all the unregulated medical devices in the country. And without the data and facts, it is impossible to take correct policy decisions.”
The meeting was attended by the AIMED, global medical device firms and the Advanced Medical Technology Association, a medical device trade association based in Washington.