April 15, New Delhi: On April 7, Central Drug Standards Control Organisation has asked patients and doctors to report adverse events associated with bioresorbable stents by sending an email to the Drug Controller General of India (DCGI).
But to the utter surprise, the department has no mechanism, whatsoever, to deal with such cases says a TOI report. The department can neither examine such reports nor take action on them in the absence of any mechanism to deal with such discrepancies in medical services.
The report claims that even the Materio Vigilance programme of India (MvPI) that was launched in July 2015 to monitor safety of medical devices has not commenced yet.
The DCGI GN Singh has said that there is no mechanism to take corrective measures on patients’ complaints or an effective way of disseminating warnings and alerts to the public regarding devices.
He said, they are dependent on device manufacturers to report adverse events. “We have asked Abbott (the manufacturers of the bioresorbable stent Absorb about which the alert was issued) to give an explanation. We are going to be very strict about protecting the Indian patient,” said Dr Singh.
Depending on companies to report something that goes against their own interests is certainly shocking and only exposes the slackened attitude of authorities in meeting the medical redressals.
“Waiting for the company to supply information about adverse events is absurd. Abbott should be made to come forward with all the global clinical data on Absorb. The data, particularly on Indian patients through trials and post marketing surveillance done in India, must be studied by experts,” said Malini Aisola of All India Drug Action Network to TOI. Malini works on the regulation of drugs and medical devices.
Another flaw in the directive of DCGI is it asks patients and medical professionals to write to the manufacturers and importers of these medical devices.
Now why would patients write to companies whose products they are complaining about?
However the Officials at the MvPI said that the Indian Pharmacopoeia Commission in Ghaziabad is the national coordination centre for the materio vigilance programme. The centre has a toll-free number and a medical device adverse event reporting form.
They insisted that the programme is running. “When we get a report of an adverse event related to a medical device, the causality of the event will be determined by the monitoring centre specialising in that device or field of biomechanical engineering.”
He further says that the companies are supposed to report to the DCGI while patients and doctors report to the MvPI. The reports are afterwards collated to take the action by the DCGI’s office explained the officials.