A city-based company Vascular Concepts Ltd, dealing in manufacture and import of medical devices, including coronary stents, which are used for relieving cardiac ailments, approached the High Court challenging the government's decision making it mandatory for the medical devices to be approved by not only the Drugs Controller General of India, but also by the US Food and Drug Administration.
The government, however, claimed that approval from both DCGI and USFDA was insisted upon in larger public interest and that it does not wish to take any chance in the matter of health of the patients who were likely to receive the stents.
A division bench of Justices V M Kanade and A K Menon accepted this contention and said the petitioner company has failed to establish that the government has acted in an arbitrary or malafide or in a manner that can be said to be against public interest.
The Court further held that the stents being imported pursuant to the tender issued are to be used in hospitals under the Rajiv Gandhi Arogya Yojana.
"The state government in its endeavour to ensure that best possible equipment is obtained for discharge of its social responsibility has, therefore, taken a decision in public interest," the bench said while dismissing the petition.
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