DCGI mandates adherence to BIS standards for medical devices, strengthening of testing protocols

The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has mandated that medical gadget suppliers and in-vitro analysis (IVD) screening labs abide by the Bureau of Indian Standards (BIS) for item screening. 

This directive follows records of several circumstances where clinical gadgets were not examined according to recognized standards, possibly compromising item top quality and posturing health threats. 

In a communiqué to clinical screening research laboratories registered with the Central Drugs Standards Control Organization (CDSCO), the DCGI kept in mind that medical devices with available BIS criteria were not being checked according to the guidelines. 

Compliance Measures

” It may be ensured that the samples of the clinical gadgets adhere to the BIS standards for quality and efficiency, and accordingly the medical devices shall be evaluated concerning the demands as suggested in the BIS criteria.” Mint assessed the instruction. 

Nonetheless, thinking that roughly 6,000 clinical tools remain in use for numerous medical treatments in India. Still, just around 1,500 BIS standards are currently available, the Ministry of Health and Household Welfare has authorized all stakeholders to also assess items under the Medical Device Rules (MDR), 2017.

“If no BIS requirements are readily available, then just various other standards of the MDR may be applied,” it claimed. The relocation seeks to enhance the quality, security, and performance of medical devices and IVDs, along with reinforcing the pan-India testing infrastructure, it added. 

India heavily depends on imported clinical tools, which account for 80% of its supplies. Importing, producing, advertising, and marketing these gadgets requires a license.

Aligning Testing Standards 

The CDSCO, with the Pharmacopoeia Commission, has set its testing requirements straightened with World Health Organization (WHO) standards, with MDR serving as a compliance checklist for makers. In cases where BIS or MDR criteria are not readily available, screening may adhere to criteria developed by the International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC). 

Security: Top Priority 

Sector specialists welcomed the step. “BIS screening norms play an important function in guaranteeing clinical gadgets’ top quality and security. These standards would certainly make sure extensive testing and examination, which ensures their compliance with nationwide safety and performance needs,” claimed Jatin Mahajan, assistant, Association of Diagnostic Manufacturers of India.

“Adherence to BIS standards not only instills the count on of healthcare providers and individuals in the reliability of the tools, but additionally advertises harmonization of market standards. Additionally, they help mitigate risks related to using medical tools, consequently safeguarding public health and improving India’s healthcare infrastructure,” he included.

Adapting Standards 

According to Rajiv Nath, forum planner at the Association of Indian Manufacturers of Medical Devices (AiMeD), licensed producers, declaring to comply with the BIS criteria, need to exhibit conformity by obtaining their items checked at the National Accreditation Board for Testing and Calibration Laboratories (NABL)- approved labs. 

Additionally, they can set up internal labs, which are accredited specifically for BIS requirements, and publish the in-house examination outcomes. “Just any accreditation insurance claim to some other product screening standards will certainly refrain from doing.”

“Medical gadgets are regularly undertaking adjustment and innovation so it may not be possible for every product to have an existing BIS or ISO product standards, for this reason, the MDR 17 allows producers to lay down their own item requirements or joint industry criteria,” Nath explained.

“But whatever they declare, they need to demonstrate compliance by tasting testing as part of a conformity assessment and danger monitoring framework to ensure consistent top quality for ensuring people’s safety and security.”