Asia-Pacific Roundup: Pakistan’s DRAP starts urgent recall of ethylene glycol-tainted products

The Drug Regulatory Authority of Pakistan (DRAP) is urgently recalling seven products manufactured by Davis Pharmaceutical Laboratories because of the discovery of ethylene glycol at “unacceptable levels.”
 
Earlier this month, Gambia’s Medical Control Agency issued a safety alert about a batch of KOF Relief Syrup, a product that contains a combination of ingredients designed to relieve dry coughs and other cold symptoms. Gambia, where tens of children died last year after using cough syrups, found the batch contained unacceptable levels of the contaminant ethylene glycol.
 
The batch was made by Davis Pharmaceutical Laboratories, a manufacturer based in Islamabad, Pakistan. DRAP’s recall covers KOF Relief Syrup, and six other products made using the same sources of glycerin and propylene glycol, the likely causes of the contamination. Four of the products, including KOF Relief Syrup, were manufactured for export.
 
DRAP has told Davis to immediately recall all the suspected batches from the market and asked people working at distributors and pharmacists to immediately check their stock and stop supplying the affected batches. The agency wants pharmacists to quarantine any affected batches and return them to suppliers. DRAP’s field force is stepping up surveillance to ensure the products are removed from the market.
 
An official at the National Health Services, Regulations and Coordination told The News on Sunday that “not a single product of this company has been found at the pharmacies in the country.” The official said that DRAP is expected to take “stern action” against the syrup manufacturer, potentially by canceling its production license and, if criminal negligence is revealed, by arresting the owners. While the KOF Relief Syrup was made in 2021, DRAP has sealed Davis’ syrup section and is planning industry-wide actions.
 
“We have also directed the DRAP to take action against all the pharmaceutical companies which are not following good manufacturing practices and producing substandard medicines. We only need companies that follow international standards of medicines’ manufacturing,” the official said. The response reflects concerns that quality problems will damage Pakistan’s reputation at a time when it is trying to increase drug exports.
 
DRAP Notice, The News on Sunday
 
TGA issues alert about Abbott diabetes app over delayed blood sugar monitoring alarms
 
Australia’s Therapeutic Goods Administration (TGA) has published a safety alert about Abbott’s FreeStyle LibreLink Android app. The alert describes a fault that could prevent users from receiving information they need to manage their blood sugar levels.
 
The app provides data from the FreeStyle continuous glucose monitor (CGM) to the user’s mobile phone, allowing users to check their glucose levels and receive high and low blood sugar alarms.
 
The Consumer Level Product Defect Correction shared by TGA describes a problem that affects people who run the app on Android 13, the latest version of the mobile operating system.
 
“Users may experience extended periods of signal loss and during this time they won’t receive high or low glucose alarms,” according to TGA.
 
Abbott plans to update the app to fix the fault by early March. In the meantime, it is asking people who have not upgraded the Android 13 operating system to hold off until the updated app is available and provided additional tips for managing in the meantime.
 
TGA Notice
 
DRAP seeks feedback on planned changes to drug research regulations
 
DRAP has released planned revisions to Pakistan’s Drugs (Research) Rules, 1978 for consultation. The proposal will change the rules on how DRAP can use a fund set up to support activities, including basic and operational research.
 
The current rules state that DRAP can use the fund for research, scholarships, the development and evaluation of drugs, and to upgrade its facilities. The proposed update would allocate the fund to “basic and operational research subject to such conditions as may be specified by the Committee of Experts on Drug Research.”
 
Additionally, the proposed regulation would allow DRAP to “utilize the Fund for establishment and operation of its laboratories, offices, pharmacovigilance center, antimicrobial consumption surveillance cell, drug information and poison control center, unit for reference standards as per pharmacopeial monograph, databases and data centers including digitization of record of therapeutic goods and related activities for international accreditations,” the draft states. “The Authority may facilitate provinces for upgradation of provincial drug testing laboratories and pharmacovigilance centers.”
 
DRAP is planning to make other small changes throughout the text. The 14-day comment period began on 21 February.
 
Draft Changes
 
Philippine FDA sets up task force to streamline shift from emergency COVID authorizations
 
The Philippine Food and Drug Administration (FDA) has created a program to streamline the transition from emergency use authorizations (EUAs) to full approvals of COVID-19 treatments, seeking to
 issue Certificates of Product Registration and make the treatments “readily-accessible to the general public in FDA-licensed drug establishments.”
 
FDA will make the medicines available “with the assurance that any post-market issues will be addressed through more rigorous surveillance and pharmacovigilance.” Four holders of EUAs for COVID-19 drugs have applied for full registration.
 
Led by director general Samuel Zacate, FDA will create a specialized team to support the plan and shift the focus of the agency “from COVID-19 crisis management to a more robust recovery of the national economy.” FDA is encouraging drugmakers to fulfill the requirements for full registration and file their applications.
 
FDA Notice
 
Malaysia’s MDA creates online payment system for medical device regulatory services
 
Malaysia’s Medical Device Authority (MDA) has established the BayarNow online payment system to accept payments for training fees, product classification letter application, Certificate of Sales and other activities that cannot be processed through the Medcast 2.0+ online portal.
 
When MDA approves an application, the system will send a link to the medical device company via email. The link will enable the company to pay for the service online via the Financial Process Exchange, instead of using a bank draft. MDA is encouraging customers to use the BayarNow service from now on in the belief that it will simplify the payment process.
 
To support the transition, MDA has created a BayarNow user manual that explains how to register, login and use the system to view and pay invoices for medical device regulatory services.
 
MDA Notice
 
Other news:
 
Pakistan’s DRAP has published changes to the Medical Devices Rules, 2017. The changes affect a section on exemption from the rules. While the original text set exemption periods ranging from six to 24 months from the commencement of the rules, the update resets the end of the transition period to the end of 2023 or 2024, depending on the class of medical device. DRAP Notice
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is set to discuss interleukin inhibitors and the risk of pancreatitis at a meeting of its Medicines Adverse Reactions Committee next month. Medsafe Notice