Asia-Pacific Roundup: WHO warns on contaminated cough syrups linked to child deaths

RoundupsRoundups | 17 January 2023 |  By 

The World Health Organization (WHO) has published a medical product alert about contaminated cough syrups linked to the deaths of 18 children in Uzbekistan. Marion Biotech, an Indian business, is the stated manufacturer of both products.
In late 2022, the Uzbekistan Ministry of Health announced the results of its investigation into DOK-1 Max, a syrup used to treat cold and flu symptoms. Preliminary laboratory studies found the syrup contained ethylene glycol, a contaminant linked to the deaths of children in The Gambia and Indonesia. In Uzbekistan, 21 children developed acute respiratory disease after taking DOK-1 Max; 18 died.
According to the WHO medical product alert, testing by national quality control laboratories found DOK-1 Max and a second product, Ambronol syrup, contain “unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants.” The products have marketing authorizations in Uzbekistan and other countries in the region and may have been distributed to other countries and regions “through informal” markets.
“WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country,” according to the alert.
Authorities think the roots of the problem are in India and, specifically, Marion Biotech’s operation in Uttar Pradesh. “To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” according to the alert.
Indian newspapers reported that drug inspectors visited Marion Biotech’s facility late last year and took samples for testing. Because Marion Biotech was unable to provide documents related to the production of DOK-1 Max, the government suspended the company’s production license. The production license is still suspended as of the most recent report, and the results of tests on the syrup are pending publication. The syrups were not sold in India.
Quramax Medical imported the medicines into Uzbekistan. In its press release, the Uzbekistan Ministry of Health said that seven people were fired because they were negligent and failed to analyze child mortality and take the necessary measures in a timely manner.
WHO issued its alert on the day the Philippine Food and Drug Administration (FDA) provided an update on its investigation into contaminated syrups. Procter & Gamble Philippines is recalling Sangobion Kids, a vitamin syrup, because ethylene glycol is present above the maximum allowable limit. FDA has received 18 adverse drug reactions about the syrup, none of which were life-threatening or fatal.
WHO Alert, Press Release (Russian), FDA Notice
Malaysia’s MDA posts guidelines on how to apply for registration of refurbished medical devices
Malaysia’s Medical Device Authority (MDA) has published guidelines on how to apply for registration of a refurbished medical device as part of its efforts to help the industry comply with the Medical Device Act (Act 737) and associated regulations.
MDA has worked to clarify the rules on refurbished medical devices over the past year, publishing requirements for such products early in 2022 and following up with guidelines on applications last week. The first edition of the new guidelines centers on a flowchart that describes the steps involved in registering refurbished medical devices and an accompanying explainer.
Companies need to determine if the product meets the definition of refurbished medical device; if so, classify and group the product before arranging a conformity assessment. Another table in the guidelines explains the conformity assessment requirements.
A conformity assessment template is provided as an appendix, including a checklist that covers topics such as the classification, intended use and grouping of the medical device, plus questions related to the conformity of the manufacturing systems for quality management and postmarket surveillance.
Once the conformity assessment is complete, the company can apply for registration via the MeDC@St device portal. The timelines and fees involved depend on the class of medical device, with reviews of higher-risk products taking longer and costing more. If, after a process that can feature requests for more information, a device is found to meet the requirements, the company needs to pay the registration fee.
MDA Guidelines
Philippine FDA launches program to help small businesses overcome lack of regulatory knowledge
The Philippine FDA has partnered with local government units to create a program aimed at micro, small and medium enterprises (MSME). FDA established the program in response to the need to create jobs and drive growth as the Philippines tries to recover from the pandemic.
MSMEs in the manufacturing and service sectors are part of the Philippines’ recovery strategy but FDA sees issues that are holding businesses back, noting that “the challenge for MSMEs is on insufficiency, if not lack of knowledge on the technical and safety requirements.” The agency cited good manufacturing practices as an area in which MSMEs can lack knowledge.
According to FDA, lack of knowledge at MMSEs on regulated activities often stems from “limited technical and/or financial capacity.” The agency wants to address those shortcomings.
FDA framed the new program as part of its assistance to smaller companies, “recognizing their specific needs, promoting entrepreneurship, supporting entrepreneurs, encouraging the establishment of MSMEs and ensuring their continuing viability and growth.” The program is intended to “promote, support, strengthen, and encourage the growth and development of MSMEs.”
FDA Notice
Indian committee waives need for AstraZeneca to run local late-phase clinical trial of COPD drug
A subject expert committee (SEC) has recommended that AstraZeneca be allowed to import and market a fixed-dose combination drug to treat chronic obstructive pulmonary disease (COPD) without running a Phase 3 clinical trial in India.
AstraZeneca sells the product in the EU as Trixeo Aerosphere and in the US as Breztri Aerosphere, as well as in other markets. Having secured the global approvals, the firm asked the pulmonary SEC to allow it to import the combination of budesonide, glycopyrronium and formoterol fumarate dihydrate without running a Phase 3 trial in the Indian population.
The SEC supported the proposal on the condition that AstraZeneca runs a Phase 4 clinical trial. AstraZeneca has three months from the date of approval to submit a protocol to the Central Drugs Standard Control Organization for assessment.
Meeting Minutes
Other news:
Australia’s Therapeutic Goods Administration (TGA) has shared an update on the nationwide shortage of certain antibiotics. Manufacturing issues and unexpected increases in demand have resulted in shortages of several antibiotics in Australia but alternatives for many affected products are available, according to TGA. The regulator is seeking and prioritizing applications for overseas alternatives. TGA Notice
Philips has expanded the Australian product defect correction for its HeartStart automated external defibrillators. TGA Notice


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you