Observing that the government can impose stringent technical requirements to provide best possible medical devices for the purpose of public health programmes, the Bombay High Court refused to quash and set aside bids issued by the Maharashtra Government to procure coronary stents.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 company sought quashing and setting aside of the government's order allotting bid to US-based companies – India Medtronics Ltd and Abbot Healthcare. According to the company, approval from the DCGI was sufficient. 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.
News On AIR | April 23, 2014 8:54 AM
DCGI and USFDA nod must for procuring coronary stents: B'bay HC