Erba Transasia Group, India’s leading InVitro Diagnostic company, is proud to announce a groundbreaking achievement: it has become the first company in India to receive the Bureau of Indian Standards (BIS) certificate for its fully automated range of clinical chemistry analyzers, including the XL 200/EM 200 and XL 640 models. This significant milestone, achieved under the IS standards 17717:2023, marks a major step forward in India’s commitment to affordable, accessible, and high-quality clinical diagnostic solutions.
 
Government of India has launched BIS quality certification as an Indian alternative to CE quality certificate and US FDA Quality certificate. Most Erba Transasia instruments already had a CE mark. Now this BIS certification, awarded to Transasia clinical chemistry products, further underscores Erba Transasia’s commitment to upholding the highest standards of quality, safety, and reliability in its products. By obtaining this certification, Erba Transasia highlights the national significance of the BIS as a benchmark for excellence in manufacturing and regulatory compliance. This achievement also contributes to India’s growing reputation as a hub for advanced, high-quality medical technology, supporting the Make in India initiative. Transasia actively advocates for the enforcement of the Quality Control Order (QCO) in the IVD sector and recommends that only BIS-certified instruments be sold in India, thereby bolstering customer trust and safeguarding public health.
 
“This achievement is a significant milestone for Erba Transasia and an important moment for India’s healthcare ecosystem. By meeting the stringent BIS standards, we are proud to deliver world-class products that are not only made in India but are accessible and affordable for the entire country,” said Suresh Vazirani, Founder Chairman of Erba Transasia Group. “Our commitment to providing quality healthcare solutions while advancing India’s manufacturing capabilities aligns with the vision of Make in India—bringing accessible, high-quality healthcare solutions to the global market.”
 
The achievement also marks a critical step in the company’s regulatory compliance journey, with further expansion planned, including the addition of several more Erba analyzer under the BIS certification process and one of the largest IVD factories in Vizag.