CDSCO to issue show cause notices to unlicensed manufacturers of orthopedic implants

The Central Drugs Standard Control Organization (CDSCO) will be soon issuing show cause notices to 29 firms and five traders who were found manufacturing and selling orthopedic implants without licences in recent raids.

According to a CDSCO official, these plants were found violating the norms under the Drugs and Cosmetics Act and Rules, 2018 in the selling and manufacturing of orthopedic implants.

"We are in the process of issuing show cause notices to these firms and traders and working on the details of the firms," the official said Saturday.

On March 11, inspectors at CDSCO conducted raids at 45 medical devices plants in four states, and found 29 of them and five traders manufacturing or selling orthopedic implants without licence or approval.

 

Further many of the units were using substandard material in unclean conditions, officials said.

Twenty-five firms were raided in the national capital, while searches were carried out in eight such facilities in Maharashtra, a senior official said, adding six firms each in Gujarat and Uttar Pradesh were also raided in a joint operation with officials of the states concerned.

"In the last two months, the CDSCO's intelligence cell gathered information from across the country regarding manufacture of various orthopedic implants without licences.

"It received information that a large number of unlicensed manufacturing activities were being carried out in Delhi, Uttar Pradesh, Gujarat and Maharashtra. Based on this information, the raids were carried out," the official said.

The intelligence cell at CDSCO was constituted in March, 2018. During raids, the officials found that the manufacturers did not hold valid licences and the devices were being made using substandard material in unclean conditions.

It was also found that the firms did not have quality management systems in place as is required under the Medical Devices Rules. Neither did the facilities conduct laboratory tests. Also they were just assembling the products and terming it as being manufactured by them, the official added.