DCGI mandates adherence to BIS standards for medical devices and strengthened testing protocols

New Delhi: Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has directed medical device manufacturers and in vitro diagnostic (IVD) testing laboratories to comply with the requirements of the Bureau of Indian Standards (BIS) for product testing.

This directive follows reports of several cases where medical devices were not tested in accordance with established standards, potentially resulting in a deterioration of product quality and posing health risks.

In a notification to medical testing laboratories registered with the Central Drugs Standards Control Organization (CDSCO), DCGI noted that medical devices meeting the available BIS standards were not tested as per the guidelines.

Compliance measures

“It can be ensured that medical device samples meet the BIS standards in terms of quality and performance, and therefore the medical devices will be tested against the requirements set out in the BIS standards.” The directive has been reviewed by Mint.

However, considering that around 6,000 medical devices are used for various medical procedures in India but only around 1,500 BIS standards are currently available, the Ministry of Health and Family Welfare has mandated all stakeholders to evaluate the products as per the Medical Devices Regulations (MDR) as well ), 2017.

“If no BIS standards are available, only other MDR standards can be used,” he said. This move is aimed at improving the quality, safety and performance of medical devices and in vitro diagnostic medical devices, as well as strengthening pan-India testing infrastructure, he added.

India relies heavily on imported medical devices, which constitute 80% of its supply. The import, production or sale of these devices requires a license.

Unification of testing standards

CDSCO, through the Pharmacopoeia Commission, has established its own testing standards in line with those of the World Health Organization (WHO), with the MDR serving as a compliance checklist for manufacturers. In cases where BIS or MDR standards are not available, testing may be in accordance with standards established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Safety: top priority

Industry experts welcomed the move. “BIS testing standards play a key role in ensuring the quality and safety of medical devices. These standards will ensure rigorous testing and evaluation to ensure compliance with national safety and performance requirements,” said Jatin Mahajan, Secretary, Diagnostic Manufacturers Association of India.

“Compliance with BIS standards not only builds trust among healthcare providers and patients in the reliability of products, but also promotes the harmonization of industry standards. Additionally, they help reduce the risks associated with the use of medical devices, thereby protecting public health and improving the healthcare infrastructure in India,” he added.

Compliant with standards

According to Rajiv Nath, forum coordinator at the Association of Indian Medical Device Manufacturers (AiMeD), licensed manufacturers, while claiming to follow BIS standards, must demonstrate compliance by having their products tested at the National Accreditation Board of Testing and Calibration Laboratories (NABL)-accredited laboratories.

Additionally, they could create their own laboratories that are accredited specifically to BIS standards and publish the results of internal tests. “No claim for accreditation against other product testing standards will suffice.”

“Medical devices are subject to constant change and innovation, so it may not be possible for every product to have existing BIS or ISO standards, so MDR 17 allows manufacturers to set their own product specifications or common industry standards,” Nath explained.

“However, whatever they claim, they must demonstrate compliance by testing samples as part of the compliance assessment and risk management framework to ensure consistent quality to ensure patient safety.”

Inquiries to the Ministry of Health spokesman remained unanswered as of press time.