Four months after The Indian Express published Implant Files, a series of investigative reports on the unregulated medical bazaar in India, the government is preparing a “regulatory pathway” for the industry that will cover all medical devices.
The Indian Express investigation, conducted in association with The International Consortium of Investigative Journalists (ICIJ), found how the first Bill to regulate medical devices was drafted 12 years ago but was still not enacted. And how global pharma majors are pushing such devices — from coronary stents and pacemakers to breast and knee implants — into markets via a dubious nexus with hospitals and doctors.
Bigger net, specific deadlines
For an industry that has largely operated without a regulatory framework, a key element of the government’s new plan is a ban on the sale of medical devices if makers and importers miss specified deadlines for registration and licensing. Significantly, the new framework will cover all medical devices and not just the 23 that have been officially notified so far.
The minutes of an official meeting held on February 8 to prepare a roadmap reveal that the government is now looking at the Singapore model that involves bringing medical devices under a regulatory regime in a three-phased manner based on risk classification.
Besides, the government has again proposed that all medical devices be regulated under the Drugs and Cosmetics Act and the 2017 Medical Device Rules, the minutes show. Currently, only 23 categories of devices, out of about 5,000 in the market, are notified for regulation by the Central Drugs Standard Control Organization (CDSCO).
This will now be expanded to cover all medical devices, the minutes reveal.
In the first phase, the proposal is for all manufacturers and importers of non-regulated medical devices to register their products voluntarily within 18 months after which they will be notified for regulation.
In the second phase, all registered Class A and B devices will need mandatory licensing within 12 months. “After the 12-month period, no person, company, organization should be allowed to manufacture, import, sell or distribute Class A and Class B medical devices without prior license…,” the minutes state.
For all Class C and D devices, another 18 months will be given for registration and 24 months more — after registration in Phase 1 — for mandatory licensing. Those who miss these deadlines will not be allowed to sell, import or manufacture these devices.
Besides, the minutes show, the onus is on manufacturers and importers to report all serious adverse events (SAEs) linked to their products to the CDSCO and the Materiovigilance Programe of India (MvPI) for authorities to take “adequate regulatory interventions and ensure patient safety”.
The Singapore model was picked after systems in the US, Canada, Australia and Japan were also examined at the high-level meeting that was attended by key officials from the Ministry of Health, CDSCO and representatives from various associations and chambers associates with the industry.
During the February meeting, the minutes show, the Ministry of Health admitted that “many medical devices are not yet regulated and are available in the market without any certification or regulatory control, putting patient safety at risk…this also undermines the image of the Government as far as medical device regulatory system is concerned”.