India is taking efforts to strengthen the safety oversight of healthcare products. One key initiative is the establishment of a national registry for implantable medical devices, such as cardiac stents and orthopedic implants. The registry will allow regulators and healthcare providers to track implantable medical devices throughout their lifecycle and link them to patient outcomes. This is expected to improve traceability, support product recalls, and help flag potential safety concerns sooner.
The Central Drugs Standard Control Organization (CDSCO) has also developed new guidelines for how drug and medical device regulatory inspectors will take samples from drugs and medical devices. Under the new guidelines, inspectors will be required to collect a minimum number of samples from products each month and to use risk-based sampling strategies. Specifically, products that have previously had quality issues and products from higher-risk supply chains will be further scrutinized. These initiatives reflect India’s clear commitment to strengthening post-market surveillance across the healthcare sector.
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.