<p>The Union Health Ministry has asked the states and central health agencies to open their doors for Indian products while procuring medical devices like coronary stents.<br /><br /></p>.<p>Last month, the ministry had sent an advisory to all the agencies asking them to change their tender conditions so that Indian medical device manufacturers too can take part in the bids, sources told DH.<br /><br />If the states relent and modify the procurement documents, then it may lower the cost of several medical procedures, including coronary angioplasty, as Indian devices are available at a fraction of the cost of the imported instruments.<br /><br />The July 18 advisory directs the health agencies to consider the Central Drug Standards Control Organisation (CDSCO) permitted medical devices rather than insisting on the US Food and Drug Administration (USFDA) approval.<br /><br />A large number of tenders by the central and the state health agencies insisted on USFDA certifications to qualify for the same, which is a disadvantage for the domestic sector. The tenders often do not even consider alternative options such as ISO 13485 certification. “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,” says the advisory.<br /><br />Besides the coronary stents, other common devices procured in bulk are chemistry analysers, opthalmological equipment and lenses; several types of evacuation tubes and in-vitro diagnostic equipment and reagents.<br /><br />“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.<br /><br />Nath claimed while the Indian medical industry grew in the last 15 years, the hospitals and health agencies continue to stick to old norms. <br /></p>
<p>The Union Health Ministry has asked the states and central health agencies to open their doors for Indian products while procuring medical devices like coronary stents.<br /><br /></p>.<p>Last month, the ministry had sent an advisory to all the agencies asking them to change their tender conditions so that Indian medical device manufacturers too can take part in the bids, sources told DH.<br /><br />If the states relent and modify the procurement documents, then it may lower the cost of several medical procedures, including coronary angioplasty, as Indian devices are available at a fraction of the cost of the imported instruments.<br /><br />The July 18 advisory directs the health agencies to consider the Central Drug Standards Control Organisation (CDSCO) permitted medical devices rather than insisting on the US Food and Drug Administration (USFDA) approval.<br /><br />A large number of tenders by the central and the state health agencies insisted on USFDA certifications to qualify for the same, which is a disadvantage for the domestic sector. The tenders often do not even consider alternative options such as ISO 13485 certification. “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,” says the advisory.<br /><br />Besides the coronary stents, other common devices procured in bulk are chemistry analysers, opthalmological equipment and lenses; several types of evacuation tubes and in-vitro diagnostic equipment and reagents.<br /><br />“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.<br /><br />Nath claimed while the Indian medical industry grew in the last 15 years, the hospitals and health agencies continue to stick to old norms. <br /></p>
