India’s Drugs Controller General of India (DCGI) has implemented new measures to reinforce the monitoring of medical device related adverse events. This initiative is part of the Materiovigilance Programme of India (MvPI), managed by the Indian Pharmacopoeia Commission (IPC), which is in charge of collecting and analyzing data on adverse events to mitigate public health risks.
One key aspect of the regulatory update is the improved version of the adverse event reporting form. This form can be used by different stakeholders, including importers, manufacturers, healthcare professionals, and others with knowledge of adverse events. The confidentiality of the form means that the identity of both the patient and the person filing the complaint is kept confidential, protecting them from any potential repercussions.
The revised form is comprehensive, requiring detailed information about the product, such as its risk classification, the manufacturer’s or importer’s license number, the year the product was made, etc. It also includes fields for a rigorous description of the adverse event, potential underlying causes, and corrective measures that will be implemented.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.