New Delhi: The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has mandated that medical device manufacturers and in-vitro diagnostic (IVD) testing laboratories comply with the Bureau of Indian Standards (BIS) for product testing.
This directive follows reports of several instances where medical devices were not tested according to established norms, potentially compromising product quality and posing health risks.
In a communiqué to medical testing laboratories registered with the Central Drugs Standards Control Organization (CDSCO), the DCGI noted that medical devices with available BIS standards were not being tested in accordance with 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 was reviewed by Mint.
However, considering that approximately 6,000 medical devices are in use for various medical procedures in India, but only around 1,500 BIS standards are currently available, the ministry of health and family welfare has authorized all stakeholders to also evaluate 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 said. The move seeks to enhance the quality, safety, and performance of medical devices and IVDs, as well as strengthen the pan-India testing infrastructure, it added.
India heavily relies on imported medical devices, which account for 80% of its supplies. Importing, manufacturing, or marketing of these devices requires a licence.
The CDSCO, through the Pharmacopoeia Commission, has set its own testing standards aligned with World Health Organization (WHO) norms, with MDR serving as a compliance checklist for manufacturers. In cases where BIS or MDR standards are not available, testing may conform with standards established by the International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC).
Industry experts welcomed the move. “BIS testing norms play a crucial role in ensuring the quality and safety of medical devices. These standards would ensure rigorous testing and evaluation, which guarantees their compliance with national safety and performance requirements,” said Jatin Mahajan, secretary, Association of Diagnostic Manufacturers of India.
“Adherence to BIS norms not only instills the trust of healthcare providers and patients in the reliability of the devices, but also promotes harmonization of industry standards. Additionally, they help mitigate risks associated with the use of medical devices, thereby safeguarding public health and enhancing India’s healthcare infrastructure,” he added.
According to Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD), licensed manufacturers, claiming to adhere to the BIS standards, must exhibit conformity by getting their products tested at National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited labs.
Additionally, they could set up in-house laboratories, which are accredited specifically for BIS standards, and publish the in-house test results. “Just any accreditation claim to some other product testing standards will not do.”
“Medical devices are constantly undergoing change and innovation so it may not be possible for every product to have an existing BIS or ISO product standards, hence the MDR 17 permits manufacturers to lay down their own product specifications or joint industry standards,” Nath explained.
“But whatever they claim, they need to demonstrate compliance by sampling testing as part of a conformity assessment and risk management framework to ensure consistent quality for assuring patients’ safety.”
