Asia-Pacific Roundup: Indian government approves adverse event monitoring plan for transplantation products
The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation.
Hailed by the government as a significant expansion of India’s patient-safety framework, the program is intended to strengthen the reporting, assessment, monitoring, and prevention of adverse events. India already has similar programs for drugs and medical devices, its pharmacovigilance and materiovigilance initiatives, respectively. The new program extends monitoring to another class of products.
The Indian Pharmacopoeia Commission (IPC) will lead monitoring of transplantation-related adverse events, including those linked to products administered to donors and recipients. The new initiative is called the Biovigilance Programme of India.
Officials unveiled the program at the IPC’s sixth National Pharmacovigilance Week. IPC used the event to make a series of announcements, including the release of the seventh edition of the National Formulary of India (NFI). The document is an important bridge between scientific standards and clinical practice, a government minister said, adding that NFI supports the appropriate and rational use of medicines.
The government also used the event to unveil the ADR-PvPI 2.0 Mobile App for iOS users. The mobile app enables users to report adverse events. Features of the second version of the app include a new interface designed for better navigation and engagement, the inclusion of a concomitant medication field, support for attachment uploads, and a web-based dashboard for analyzing and exporting data.
The updates are intended to strengthen India’s capacity to collect and analyze adverse event data. India is now a leading contributor to the World Health Organization’s patient safety database, reflecting a rapid rise from a time when it was outside the top 100. About 1,150 adverse drug reaction reporting centers, plus medical device vigilance facilities, are active at Indian hospitals and medical colleges.
Hong Kong and Brazil ink pact to deepen exchanges and cooperation on drugs and devices
Hong Kong’s Department of Health (DH) has signed a memorandum of understanding with the Brazilian Health Regulatory Agency (ANVISA).
Under the MOU, the two sides will establish a mechanism for cooperating and exchanging information on the regulation of medical devices and drugs, including biologics and traditional medicines. The MOU is intended to protect and promote the health of people in Brazil and Hong Kong by creating a platform for high-level exchange, DH said.
The cooperation is underpinned by Brazil and Hong Kong’s participation in international initiatives. Both sides participate in the Pharmaceutical Inspection Co-operation Scheme and the International Council for Harmonisation.
For Hong Kong, the MOU advances the agenda the government laid out in its five-year plan for 2026 to 2030. Under the plan, Hong Kong will reform medical product regulations to align with international standards, develop the capacity for independent evaluation and approval, and participate actively in global regulation to pursue recognition from international authorities.
Hong Kong is creating the Centre for Medical Products Regulation (CMPR) to further its goals. Deepening collaboration with “authoritative overseas medical products regulatory authorities” is a key strategy for CMPR, Ronald Lam, director of health for Hong Kong, said.
Hong Kong sees such collaboration as a way to help innovative medical technologies “go global” and to attract foreign investment, Lam said. Collaborating with ANVISA is the first step in the implementation of the strategy, Lam added.
Singapore’s HSA warns against unapproved peptide use after learning of adverse events
Singapore’s Health Sciences Authority (HSA) has become the latest regulatory agency to issue an alert about unapproved injectable peptides.
Like other agencies in Asia and elsewhere, HSA highlighted the risks of buying unapproved peptides through unauthorized channels after receiving reports of adverse events. HSA has received reports of people being hospitalized after consuming GLP-1 medicines bought overseas or online without a prescription and medical supervision.
Adverse events reported to HSA include severe vomiting. Australia’s Therapeutic Goods Administration (TGA) recently shared details of a person who was hospitalized with severe vomiting after using a GLP-1 drug. HSA has also received reports of anaphylaxis, a potentially life-threatening allergic reaction.
The TGA vomiting case affected a patient who bought a product purporting to be retatrutide but which actually contained semaglutide. HSA warned against buying investigational drugs such as retatrutide and cagrilintide, next-generation weight-loss drugs in development at Eli Lilly and Novo, respectively. The agency urged consumers to view labels such as “research-use only” as a warning sign.
Kidney risk spurs CDSCO warning about ‘indiscriminate’ use of painkillers and antibiotics
India’s Central Drugs Standard Control Organization (CDSCO) has warned against the “indiscriminate” use of painkillers and antibiotics.
CDSCO included “associated risk of chronic kidney disease” in the headline of its notice, although most of the body of the text is more general. The body of the text advises patients with pre-existing kidney disease or other renal impairment risk factors to tell their healthcare professional before using non-steroidal anti-inflammatory drugs (NSAIDs), a type of painkiller.
The agency also told healthcare professionals to take “appropriate precautions ... in patients with renal impairment, dehydration, cardiovascular disease, or other conditions that may increase the risk associated with NSAID use.” Healthcare professionals should use the lowest effective NSAID dose for the shortest appropriate duration, particularly in patients at increased risk of renal impairment.
Otherwise, CDSCO’s notice could apply to conditions other than kidney disease. The agency explained how NSAIDs and antibiotics are classified, noting that patients typically need a prescription to access the medicines. CDSCO listed steps different stakeholders should take to prevent avoidable adverse reactions, renal complications, and antimicrobial resistance.
TGA removes andrographis from listed medicines framework after fatal case of anaphylaxis
Adverse events have driven TGA to remove Andrographis paniculata from the ingredients allowed in new listed medicines.
The Australian regulator has received reports of anaphylaxis, an allergic reaction, linked to andrographis. A person died in 2024 after taking a product containing the medicinal plant. The adverse events informed an updated safety review and supplementary report in April and a call for feedback on the proposed removal of andrographis from the Permissible Ingredients Determination.
As of this month, new medicines containing andrographis are no longer eligible to be listed in the Australian Register of Therapeutic Goods (ARTG). However, TGA’s action has no immediate, mandatory effect on medicines already listed on the ARTG.
TGA has asked companies to voluntarily cancel affected products or recall them where appropriate. The agency may consider stronger regulatory actions, including compulsory recalls or ARTG cancellations, if companies fail to act quickly. Andrographis listed medicines may become unavailable in Australia.
Companies can still bring products containing andrographis to market but will need to use the registered medicines pathway. Under that pathway, TGA assesses a medicine’s safety, quality, and effectiveness before registering the product in the ARTG.
Other News:
Healthcare officials in Hong Kong and Macao have participated in an emergency medical product safety drill. The drill simulated a scenario triggered by an adverse event to test incident monitoring and reporting, emergency response activation, on‑site handling, public opinion management, and interdepartmental coordination. Press Release
Huang Guo, commissioner of China's National Medical Products Administration (NMPA), met with a delegation from the Gates Foundation. The two sides discussed how to build on existing cooperation. NMPA Notice
