Central Drugs Standard Control Organization(CDSCO) has conducted raids at 25 factories in Delhi alone. Whereas eight facilities were inspected in Maharashtra and six each in Gujarat and Uttar Pradesh.
New Delhi: Cracking a whip on companies manufacturing expensive devices without complying quality standards, the central drug regulator along with officers from Central Drugs Standards Control Organisation (CDSCO) has raided 45 medical device plants in the country for unlawfully manufacturing orthopaedic implants. The facilities were involved in manufacturing without a legal license or approval.
The ongoing activity came to light as a surprise inspection was carried out by 37 inspection teams with 125 officers from the CDSCO.
During the raid, the drug inspectors observed the “dirty and filthy conditions” for manufacturing the devices, underrated raw materials and lack of quality management and testing facilities.
The facilities are based in Delhi, Uttar Pradesh, Maharashtra and Gujarat. Amongst the four states, Delhi accounted for the maximum number of unapproved facilities. The central regulatory teams conducted raids at 25 factories in Delhi alone. Whereas eight facilities were inspected in Maharashtra and six each in Gujarat and Uttar Pradesh.
Following the inspection, show cause notices have been issued to the owner of the firms demanding an explanation for violating the regulatory norms.
“We are issuing show cause notices to these facilities and the owner firm asking them to explain the reason for the violation. Once we get their responses, action will be taken under provisions of the Drugs and Cosmetics Act,” a senior official told TOI.
The move assumed is indeed significant as medical devices are rapidly growing segment in India, specifically for high-end implants including cardiac and orthopaedic implants.
Despite the high prices of these medical devices and overall treatment, medical procedures are increasing at an increased pace.