The Health Ministry of India has initiated an expert panel to monitor and address medical device adverse events to help promote patient safety. The panel will comprise experts from various disciplines of medicine, such as cardiology, neurology, and radiology. These experts will analyze and advise on needed actions to be taken for adverse incidents. Medical devices, such as implants and electronic equipment, are important for the care of patients but can also create significant risks. This new program, called the Materiovigilance program, was implemented by the India Pharmacopeia Commission (IPC), where cases are reviewed, and safety recommendations are issued. This program has called for new stringent adverse event regulations that more closely correlate to international standards.
India’s Central Drugs Standard Control Organization (CDSCO) has also called upon the stakeholders of the Indian pharmaceutical industry to give their input on regulatory challenges and potential process improvements. This comes at a time when the initiative seeks to fast-track the approval and compliance procedures for drugs while maintaining high safety and quality standards. Industry leaders have long complained of delays and regulatory bottlenecks that are hampering timely patient access to essential medicines. One of the major focuses will be nurturing more innovation in advanced fields such as gene therapy, stem cell research, and personalized medicine. CDSCO invites suggestions for policy improvements and funding initiatives to support local drug innovators. Stakeholders are requested to submit their inputs as soon as possible.
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.