India proposes caps on use of imported medical devices

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The document states at least half of all medical disposables and consumables must come from local companies. (Yann Forget/CC-BY-SA-3.0)

India has proposed regulating the proportion of locally made and imported medical devices procured by public programs. The draft guidelines (PDF) called for at least 50% of some types of devices to come from Indian companies.

Local companies gained preference over foreign businesses under Indian public procurement rules last year. But those general, pan-industry rules stopped short of stipulating how the “Make in India” promotional agenda would apply to the procurement of medical devices. A draft document released by the Department of Pharmaceuticals (DoP) has now filled that gap.

The document stated that at least half of all medical disposables and consumables must come from local companies. The DoP took a somewhat looser line on the acquisition of medical electronics, hospital equipment, surgical instruments, implants, diagnostic reagents and IVDs. Public programs need to buy between 25% and 40% of these types of devices from local companies.

The DoP settled on the percentages after discussing the topic with industry representatives. In the longer term, the government body is collating data on the capacity of the local industry with a view to coming up with import caps that more accurately reflect the market.

Other aspects of the guideline defer to the rules (PDF) established last year. That document limited participation in small procurement orders to local companies, provided there is enough capacity and competition in India. And prohibited foreign manufacturers from covering more than half a purchase order, even if they were the lowest bidder.

The medical device procurement guidelines are open for comment.