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CDSCO finds 29 medical device firms violating selling and manufacturing criteria

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eMediNexus    18 March 2019

New Delhi: The Central Drugs Standards Control Organisation (CDSCO) is going to issue show cause notices to 29 medical device units that were found to be violating the norms of selling and manufacturing orthopedic implants.

Dr. S. Eswara Reddy, Drugs Controller General of India (DCGI), CDSCO, said that they will follow the Drugs and Cosmetics Act and Rules 2018 and will be issuing show cause notices to these 29 firms.

In the raids conducted by the CDSCO at 45 medical plants in four states - Delhi, Maharashtra, Gujarat and Uttar Pradesh - on March 11, 29 medical device firms and five traders were found to be manufacturing or selling orthopedic implants without licence or approval.

In Delhi, raids were conducted on 25 firms. Searches were conducted at eight facilities in Maharashtra and six firms each in Gujarat and Uttar Pradesh were raided.

According to the CDSCO, the units were manufacturing devices in dirty and filthy conditions with underrated raw materials amidst lack of quality management and testing facilities. (IANS)

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