The health ministry has issued an advisory to all state governments and central health agencies to include Central Drugs Standard Control Organization (CDSCO)-approved medical devices for being considered for procurement of medical devices and desist from insistence of USFDA approvals. The ministry has in its advisory recommended that the states and union territories may advise all concerned to ensure that in all proposals relating to procurement, CDSCO-approved medical devices should invariably be indicated as a category in the tender documents for procurement. Due to legacy reasons and blind imitations, tenders by central and state health agencies have typically insisted on USFDA certifications to qualify for the same, thus creating a big disadvantage for domestic manufacturers. The tenders often do not even consider alternative options such as ISO 13485 Certification. This resulted in the ministry's and states' denial of fair chance to the domestic manufacturers to compete in such procurements.


 

randox

Digital version