NEW DELHI: In a boost for Indian medical device makers, the government has asked states to consider doing away with the requirement of US and European regulatory certification for equipment to be purchased for state-run institutions and hospitals.
The stipulation for US or European regulatory approval excludes local manufacturers from tenders and to level the playing field, it is recommended that there should be preference for Make in India products during public procurement, the Department of Pharmaceuticals said in a recent letter to the states.
In tenders for procuring medical equipment, government hospitals and institutions typically ask for products certified by the US Food and Drug Administration, stamped with the CE mark derived from the European Medical Device Directives or approved by India’s drug controller general. Indian manufacturers allege such conditions are discriminatory and favour multinational companies.
“Domestic manufacturers face discrimination even if they have India’s drug regulatory certification, at times. This is a clear indication that some states and institutions want to only favour MNCs,” said a device manufacturer.
DoP secretary PD Vaghela said the “restrictive” and “discriminatory” tender conditions prevent the domestic industry from getting the benefits of government contracts.