New Delhi: The State Licensing Authorities (SLAs) across the country need to take part in the Materiovigilance Programme of India (MvPI) and submit the Adverse Drug Reaction (ADR) reports of materiovigilance to the Indian Pharmacopoeia Commission (IPC) on Class A and B medical devices, advises the Drugs Consultative Committee (DCC).
In the 62nd meeting of the DCC held recently, the Committee also said that all the manufacturers need to be directed by the SLAs to submit ADR reports to IPC on these Classes of medical devices.
The IPC, Ghaziabad, which functions as the National Coordination Centre (NCC) for MvPI, has put forward a proposal that the active involvement of the State Regulatory Authorities is crucial in achieving the objectives of the MvPI. The MvPI aims to promote and facilitate adverse event reporting of medical devices and subsequently evaluate these events.
According to Medical Devices Regulation (MDR) Rule 2017, Post Marketing Surveillance data (Vigilance reporting) the dossier should contain the Post Marketing Surveillance or Vigilance Reporting procedures and data collected by the manufacturer encompassing the details of the complaints received and corrective and preventive actions taken for the same.
The IPC said that the MvPI focuses on ensuring patient safety and enhancing the quality of medical devices and active involvement of the State Regulatory Authorities is crucial in achieving the program’s objectives effectively”.
“State Regulatory Authorities inclusion in the MvPI would enhance the accuracy and comprehensiveness of adverse event reporting, as well as facilitate timely intervention and corrective actions,” it added.
The DCC observed that the State Regulatory Authority can play a pivotal role in promoting awareness about the MvPI among healthcare professionals, manufacturers and consumers across the states.
The meeting concluded, “…all the States/UTs SLAs were requested to submit the ADR reports of materiovigilance to IPC on Class A & B medical devices. All the manufacturers need to be directed by SLAs to submit ADR reports to IPC on Class A & B Medical Devices”.
The MvPI was approved by the Ministry of Health and Family Welfare (MoHFW) in an effort to ensure safety of medical devices, after several horrific cases of malfunctioning medical devices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning.
In addition to protection of health and safety of patients, materiovigilance programme reduces the likelihood of recurrence of the harmful incidents elsewhere thereby improving quality of health products. The Programme was launched by the Drugs Controller General (India) on July 6, 2015.
Under MvPI clinician, biomedical engineers, clinical engineers, hospital technology manager, pharmacists, nurses, technicians can report medical device adverse events. Medical device manufacturers/CDSCO notified medical device manufacturers/ medical device importer trader can also report adverse events specific for their product.
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