India is planning to add the European Union to the list of regions covered by its clinical trial waiver rule. The change will free companies from the need to run clinical trials of medical devices that are already available in the EU when they want to access the Indian market.
In the Medical Device Rules, 2017, Indian legislators agreed to waive the need for clinical trials when a device is “approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that country.” The EU is the notable omission from that list.
Representatives of the EU pointed out the omission at a meeting of the India-EU subcommission on trade in 2018, leading to the matter being referred to the Drugs Technical Advisory Board (DTAB). In meeting minutes published this week, DTAB agreed to change the rules to include the EU.
The change was one of a clutch of recommendations made by DTAB at the meeting. DTAB also looked at good distribution practices (GDPs), a subject it has considered several times in the past. The focus on GDPs reflects a concern that the current Indian rules enable unauthorized entities to distribute and sell medicines, leading to the introduction of spurious drugs into the legal supply chain.
Faced with that problem, DTAB thinks Indian legislators should make provisions for GDPs in the Drugs and Cosmetics Rules, 1945. The recommendation follows a request for feedback on draft GDP guidelines.
