Asia-Pacific Roundup: Pakistan’s DRAP tells companies to test solvents amid oral drug contamination concerns

RoundupsRoundups | 25 October 2022 |  By 

The Drug Regulatory Authority of Pakistan (DRAP) has told manufacturers of oral formulations working with glycerin, propylene glycol and sorbitol to test the solvent for impurities and contaminants in response to child deaths in Gambia linked to contaminated cough syrup.
 
Contamination with diethylene glycol (DEG) and ethylene glycol (EG) can cause symptoms including abdominal pain and diarrhea and ultimately lead to death, particularly in children. The threat of the contaminants has been highlighted by events in Gambia, where 70 children died from acute kidney injury. The deaths are thought to be linked to cough syrups manufactured in India.
 
DRAP sees a need for “extraordinary measures and vigilant monitoring of these possible contaminants.” The agency set out its response in a notice with advice for healthcare professionals, manufacturers and importers of products containing glycerin solvent, and the public.
 
Manufacturers and importers are directed to “perform test/analysis of for presence of any toxic impurity/contaminants especially when used in oral dosage forms such as syrups/suspensions etc. It is [the] legal responsibility of all manufacturers of therapeutic goods to ensure before marketing that all the manufactured therapeutic goods are safe for consumption. Therefore, it is required that all manufacturers using these solvents must perform proper testing to detect DEG and EG contamination,” according to the guidance.
 
In a related alert, DRAP reminded manufacturers that they are “strictly bound to use pharmaceutical solvents purchased from qualified vendors only” before providing information on the testing process.
 
DRAP wants manufacturers to “perform specific identity that include limit test for DEG and EG on all containers of all lots of these solvents before use,” adding that the safety limit for the contaminants is 0.1%. Manufacturers need to provide a certificate of analysis showing the substances are below the 0.1% limit “to consume these solvents” and provide reports of already produced batches within three days.
 
If a test delivers an out-of-specification result, the manufacturer must immediately recall the product or face “strict regulatory action.” DRAP may advise federal and provincial drug inspectors to perform risk-based sampling of oral dosage forms, particularly cough syrups, and will receive weekly reports of their activities.
 
DRAP Notice
 
TGA extends processing times for GMP clearance filings
 
Australia’s Therapeutic Goods Administration (TGA) has temporarily increased the processing times for good manufacturing practice (GMP) clearance assessments by 30 days following a 36% increase in the volume of GMP clearance applications since the agency’s 2018-19 financial year.
 
The volume of GMP clearance applications has caused problems for TGA in recent years. In 2017, the agency scrapped its long-standing 15-day target timeframe for processing applications after seeing the number of applications rise from 2,500 in the 2010-11 period to 5,600 in its 2015-16 financial year. The extra work caused processing times to rise to nine weeks at one point before it introduced a new system and brought its turnaround time back toward 30 days. TGA adopted a 30-day turnaround target.
 
In 2019, TGA cleared its backlog of GMP clearance applications, but it now faces fresh difficulties. The number of applications has increased from 6,627 to 9,007, a 36% rise. TGA also reported that “the complexity of assessments has increased due to the lack of primary evidence available during the COVID-19 pandemic,” leading it to “perform a more in-depth assessment of additional manufacturer documentation.” The factors persuaded TGA to temporarily give its teams more time to process filings.
 
The target timeframe for mutual recognition agreement applications remains 30 days but all other filings are now subject to longer turnaround times. TGA has added 30 days to all the timelines. As such, the turnaround times for non-sterile and sterile active pharmaceutical ingredients are now 90 days and 105 days, respectively. The targets for non-sterile and sterile finished products are 120 days and 150 days, respectively.
 
TGA will review the timelines at the end of its financial year in June 2023.
 
TGA Notice
 
CDSCO tells state licensing authorities to accept hard copies to clear up medtech confusion
 
The Central Drugs Standard Control Organization (CDSCO) has told state licensing authorities to accept hard copies of applications for medical device registration certificates after stakeholders complained that state authorities were refusing their applications.
 
At the end of September, India implemented rules that established registration certificates to sell, stock, exhibit and distribute medical devices as an alternative to the drugs sale license. The rules state that the applicant must apply to a state licensing authority using Form MD-41 to obtain a registration certificate, which applies to medical devices including in vitro diagnostics.
 
However, CDSCO received “various representations” from stakeholders about the refusal of hard copy applications by state licensing authorities. CDSCO responded by requesting that the authorities accept the hard copy submissions and process applications “expeditiously on priority” to ensure uninterrupted access to medical devices.
 
CDSCO Notice
 
India’s NPPA pushes back deadlines for submitting drug and device pricing information
 
India’s National Pharmaceutical Pricing Authority (NPPA) has extended the deadlines for the submission of information mandated under the Drugs (Prices Control) Order, 2013.
 
Typically, NPPA gives manufacturers 15 days after the end of each quarter to submit production and sales data for scheduled drugs and 15 days after a price revision to share details of changes to the maximum retail prices of medical devices and scheduled and non-scheduled drugs. The submission times for the quarterly data are set by the DPCO, 2013.
 
NPPA has extended its deadlines for the rest of 2022 in response to “several representations requesting for extension of [the] last date for filing statutory forms ... from industry associations /  companies.” In response, NPPA has given manufacturers of scheduled drugs until the end of the year to post production and sales data for the quarter ending September 2022.
 
Similarly, the price watchdog has given manufacturers until the end of the year to report any maximum retail price changes that happened between the start of August and 15 December.
 
NPPA Memo
 
TGA provisionally approves Moderna’s COVID-19 booster in people aged 12 years and up
 
TGA has provisionally approved Moderna’s COVID-19 vaccine Spikevax for use as a booster in people aged 12 years and up.
 
Previously, the vaccine was provisionally approved to prevent COVID-19 in children as young as six months but could only be used as a booster in adults aged 18 years and older. Following the advice of the Advisory Committee on Vaccines, an independent expert body, TGA has decided to lower the minimum age for use of the vaccine as a booster.
 
TGA took the decision after reviewing data on 1,300 participants aged 12 to 17 years who received the vaccine as a booster as part of an ongoing clinical trial. The study showed that the immune response and safety profiles seen in the population were like those reported in young adults.
 
Press Release
 
Other news:
 
Pakistan’s DRAP is planning to move the process for registering drugs for export and for renewing registered drugs onto its online platform. DRAP Notice

 

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