In a move to provide push to Indian device Manufacturers, as a part of PM Modi’s Make in India Campaign, the central government is reported to have written to States as well as Central Health Agencies to amend regulations enabling Indian devices manufacturers to enter their tender process.
This comes after an advisory was issued by the centre all state governments as well as central health agencies to include medical devices approved by India’s drugs control authority Central Drug Standards Control Organization (CDSCO) for being considered for procurement. Earlier, the insistence has been on US Food and Drug Administration approvals as a technical requirement, due to which many indian device makers are unable to qualify.
“This results in denial of a fair chance to the domestic manufacturers to compete in such procurements, which not only impedes competition but also affects the Make in India effort,” stated the advisory.
The move has been hailed by the domestic indian manufacturers as a whole.
“The insistence of USFDA certification by central and state government health institutions had seriously undermined the credibility of our own regulators. No other country in the world insists on only one certification source and that too USFDA exclusively. All major countries have their own domestic or alternate international certification,” said Rajiv Nath, forum coordinator in the Association of Indian Medical Device Industry informed Deccan Herald.
Currently, these norms have been in place of number of medical devices, including stents such as cardiac, orthopedics, equipment for many major specialities including laboratory, ophthalmology and many more.