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29 firms in 4 states found manufacturing orthopedic implants without licence

twitter-logoPTI | March 14, 2019 | Updated 19:42 IST

New Delhi, Mar 14 (PTI) The Central Drugs Standard Control Organisation (CDSCO), conducted raids in four states, and found 29 medical device firms and five traders manufacturing or selling orthopedic implants without licence. Inspectors of the CDSCO under the Union health ministry conducted raids at 45 medical device firms in Delhi, Maharashtra, Gujarat and Uttar Pradesh on March 11. 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 along with the officials of the states concerned. "Out of these, 29 firms and five traders were found manufacturing or selling orthopedic implants without licences. Appropriate action is being taken against them under the provisions of the Drugs and Cosmetics Act and Rules," a senior government official said. "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 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 do not hold valid licence and the devices are being made using substandard material in unclean condition. It was also found that the firms do not have quality management system in place as required under the Medical Devices Rules neither do they any testing laboratory. Also they were just assembling the products and terming it as being manufactured by them. "In such scenarios, risks associated with these devices are several. Raw materials used for production of orthopaedic implants may not be of medical grade and biocompatibility studies are not conducted. In that case there is no assurance of quality of devices and the revision surgeries may be high," the official explained. PTI PLB PLB NSD NSD

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