Policy Matter

Centre to adopt IoT to speed up e-governance to make efficient reporting under PvPI, HvPI and MvPI


Union government is keen to adopt the internet of things (IoT) embedded with electronics, software, sensors and communication network connectivity that will bring in a major transformation in the Indian healthcare sector. In the areas of Pharmacovigilance Programme of India (PvPI) for assuring drug safety, Haemovigilance Programme of India (HvPI) to assure patient safety in blood transfusion and Materio-Vigilance Programme of India Pharmacovigilance-Programme(MvPI) for safety of medical devices, the use of IoT with cloud-based apps will bring in efficiency and transparency in real-time.

The ministry of health and family welfare is already working on evidence-based policy decisions. So long all drug safety data was based on approvals of EU and USFDA. “But now we are working to create the Indian patient data base. The ministry has already moved towards dispensing clinical trial approvals for medical devices not manufactured in the country if they are cleared from ICH countries. It is aggressively working to establish advanced labs and look at IoT which could speed up reports,” said KL Sharma, joint secretary (regulation), department of health and family welfare, government of India.

All these initiatives will see additional manpower hiring and filling up vacancies at the CDSCO. We will address the needs of critical areas for IoT driven operations. In this, the National Institute of Biologicals (NIB) training academy will be of great help to enable pharmacy and healthcare professionals to update on the global best practices. We are also moving fast towards e-governance and efforts to put in place a system is on. Before the end of March 2016, a dedicated portal to cater to disbursing medical device test reports, diagnostics analysis, processing of medical device applications and issue of licenses will be up and ready, he added.

The government will also assign the NIB to test the dengue kits as part of the Materio-Vigilance Programme of India. The decision to test dengue kits comes in after apprehensions over its sensitivity and false results that led to the ban of these diagnostic devices. At any given situation, especially in the case of vector borne diseases like dengue which reached an epidemic proportion in Delhi in August- September this year, the need for accurate diagnostic reports was found critical. Through the MvPi which ensures the safety of medical devices, we could provide accurate reports in real time if the devices are sensitive, he said.

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