New Delhi, May 31 (KNN) The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has directed medical device manufacturers and in-vitro diagnostic (IVD) testing laboratories to adhere to the Bureau of Indian Standards (BIS) for product testing.

This move aims to enhance the quality, safety, and performance of medical devices and IVDs, while strengthening the PAN-India testing infrastructure.

The directive comes in the wake of reports indicating that several medical devices were not tested according to established norms, potentially compromising product quality and posing health risks.

In a communiqué to Central Drugs Standard Control Organisation (CDSCO) registered medical testing laboratories, the DCGI noted that devices with existing BIS standards were not being tested as per the guidelines.

"It may be ensured that the samples of the medical devices comply with the BIS standards for quality and performance, and accordingly the medical devices shall be tested with respect to the requirements as prescribed in the BIS standards," the directive stated.

While around 6,000 medical devices are used in various medical procedures in India, only approximately 1,500 BIS standards are currently available.

In such cases, the Ministry of Health and Family Welfare has authorised evaluating products under the Medical Device Rules (MDR), 2017. "If no BIS standards are available, then only other standards of the MDR may be applied," it clarified.

India heavily relies on imported medical devices, accounting for 80% of its supplies. Importing, manufacturing, or marketing these devices requires a license.

The CDSCO, through the Pharmacopoeia Commission, has set its own testing standards aligned with WHO norms, with MDR serving as a compliance checklist for manufacturers.

Where BIS or MDR standards are unavailable, testing may conform to standards established by the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC).

Industry experts have welcomed the move, citing the crucial role of BIS testing norms in ensuring the quality and safety of medical devices, promoting harmonisation of industry standards, and mitigating risks associated with device use, thereby safeguarding public health and enhancing India's healthcare infrastructure.

(KNN Bureau)