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The drugs regulator has cracked down on manufacturers across India, who were illegally manufacturing orthopaedic implants, which are devices used to replace a missing joint or a bone or support a damaged bone. Under the Medical Devices Rules 2018, orthopaedic implants are categorised under Class C - high-risk devices.
The intelligence cell at the Central Drugs Standard Control Organisation (CDSCO), over the last two months has gathered substantial information from across the country regarding manufacture of various orthopaedic implants without licenses.
Thirty-seven inspection teams with 125 officers of the CDSCO carried out surprise inspections on March 11 and 45 manufacturers were identified – eight in Maharashtra, six each in Gujarat and Uttar Pradesh and 25 in Delhi.
“29 firms and five traders were found manufacturing or selling ortho implants without licenses,” said S Eswara Reddy, Drug Controller General of India (DCGI).
“A lot of these unlicensed manufacturing activities are being carried out in Delhi, Uttar Pradesh, Gujarat and Maharashtra. The officers of the cell, along with state-level officials, visited the places to verify the activities being performed in these units,” said Reddy.
He added, “The manufacturing activity was being performed in dirty, filthy conditions. They did not have quality management systems in place, required under the rules. They did not have any testing laboratory to test the goods. The quality of material being used is not as per the standards of the medical devices specified. The traders were assembling the products and selling them on their own as manufacturers.”
He further explained that the risks associated with these illegal devices are that the raw materials used for production of orthopaedic implants may not be of medical grade. “Their bio-compatibility studies have not been conducted and, thus, there is no assurance of quality of devices. The rate of revision surgery, thus, may be high, as also the possibility of the occurrence of sepsis post-surgery,” he said.
CDSCO has issued more than 250 licenses for the manufacture of orthopaedic implants in India. Orthopaedic implants have been regulated as medical devices since 2005.
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