The department of pharmaceuticals (DoP) has come out with guidelines on implementation of Public Procurement (Preference to Make in India) order, 2017 (PPP-MII Order) related to procurement of goods and services in medical devices, partially diluting requirement of US FDA/CE certification in public procurement.
The PPP-MII Order has done away with mandatory requirement of US FDA/CE certification for the medical devices which have been benchmarked by Bureau of Indian Standards (BIS) in public procurement orders. Nearly 1,000 products have been benchmarked by BIS so far.
This issue of mandatory requirement of US FDA/CE certification in public procurement has been raised from time to time by several medical device industry representatives.
The department considered the issue and DoP has amended the guidelines dated 18.05.2018 issued by it for implementation of Public Procurement Order 2017 dated 15.06.2017 by inserting para 4.1 as under
Every procurement agency should follow the standards laid down by BIS, for the medical device concerned, for procurement purposes. Where such standards exist, USFDA/CE certifications etc shall not be mandated.
Other contents of the guidelines dated May 18, 2018 remain unchanged, said DoP in a notification.
