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No Bis Lab, So PGI Unable To Launch Cost-Effective Device

CHANDIGARH: The PGI’s only patented medical device ready for market, an automated drug delivery system developed in 2016, cannot have an official launch because the Bureau of Indian Standards (BIS) has no approved laboratory to test it for certification.

Closed loop drug delivery system helps doctors monitor the ICU (intensive-care unit) patients’ vitals (temperature, respiratory rate, pulse, blood pressure, blood oxygen saturation) without staying glued to their bedside monitor. It enables them to fix a medicine dose. The device developed by professor G D Puri and his team at the Post Graduate Institute of Medical Education and Research (PGIMER) costs about Rs 8 lakh as opposed to Rs 22 lakh for the imported equivalent.

Professor Puri said: “We have been informed that the BIS is yet to authorize any laboratory to test and certify medical devices. In that case, we can ask an industry partner to test it in their laboratory in the presence of the BIS experts but even the industry doesn’t have that kind of a laboratory.”

The loop device is CE certified, validated based on the European 2018 standards, but the local market is reluctant to accept a product that’s not BIS certified. An official from the company that worked with the PGI in making the device said: “Former health minster J P Nadda had asked for all medical and electronic devices to have updated BIS standards and told manufacturers to build international-standard validation facilities. Despite international validation and compliance, we cannot launch officially.”

At the moment, if the blood pressure of ICU patients varies frequently, they have to be administered medicine through syringes controlled manually by the doctor monitoring the system. Looking at the vital parameter monitor that displays the BP, ECG etc, the doctor adjusts the syringe pump filled with BP-control medicine. If the BP is high, the syringe pump delivers drugs to make it normal. However, this flow of drugs is regulated manually according to the vital parameter monitor. The loop automates this entire system.-Times Of India

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