In March 2018, The Pharma Department proposed new procurement guidelines for at least 50% of some types of devices to come from Indian companies. India has proposed regulating the proportion of locally made and imported medical devices procurement by public programs. The Department of Pharmaceutical has proposed that the sourced components have to contribute 25-50% cost of medical devices procured by the government, depending on the category of the device.
At the same time, the new procurement guidelines lack in measures to help the local industry to grow and impose some conditions that may hurt the quality of medical devices procured through these tenders, claimed a lobby group of domestic firms in the sector.
The guidelines also may not be possible to implement for high-end, critical products for which there is currently no ecosystem available to manufacture locally, according to two lobby groups representing several multinational medical device firms. This guideline may not incentivize global medical technology companies to make in India for high-risk products like pacemakers, vascular grafts, and heart-lung machines.
The requirement for domestic sourcing is 50 percent for medical disposables and consumables and 40 percent for implants. The guidelines may not be possible to implement for high-end products because India still lacks the local production ability.
Department of Pharmaceuticals draft in its present form also does not provide any incentive to maintain and improve quality and also does not block government procurement agencies from mandating regulatory approvals from bodies like the US Food and Drug Administration, which has prevented Indian manufacturers from participating in several such contracts in the past.
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.
