In late December, Malaysia’s Ministry of Health (MOH) announced a new requirement regarding the use of a FarmaTag hologram security label on drug products. The measure is intended to strengthen labeling and authentication requirements. Also, it will enhance safeguards against counterfeit medicines and improve product traceability in the Malaysian market. Its authentication function has been integrated since January 1, 2026 into the Malaysian MyUBAT mobile application, developed by the MoH to help patients manage their medicines. This will allow users to verify products digitally through the updated platform. Foreign companies selling pharmaceutical products in Malaysia should make sure that their labeling and verification processes comply with the updated requirements to maintain product integrity and compliance.
Indian regulators have required medical device companies to improve reporting of product-related incidents to enhance patient safety and expedite corrective action. According to the Indian Pharmacopoeia Commission (IPC), all marketing authorization holders are required to report both serious and non-serious adverse events, whether expected or unexpected, to the Materiovigilance Programme of India (MvPI). Comprehensive reporting has now become a mandatory part of post-market surveillance. The new rules follow concerns that incidents have been under-reported. For example, there was a recent hip replacement recall that exposed significant gaps. Through these measures, Indian authorities hope that timely reporting will help identify risks earlier and support faster safety updates.
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.