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Asia-Pacific Roundup: Australia allows pharmacy-level substitution during shortages

Posted 09 March 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: Australia allows pharmacy-level substitution during shortages

Pharmacists in Australia now may substitute medicines when a patient’s usual treatment is in “serious scarcity” under new legislation that formalizes the Serious Shortages Substitution Notices (SSSNs) officials have used to address supply disruptions since May.
Once TGA publishes a SSSN, pharmacists can dispense substitute medicines per the rules of the notice. Only limited substitutions, such as different doses and dosage forms, are permitted under the scheme.
A new legislative instrument must be registered each time a substitute medicine is needed to address a serious scarcity. Like SSSNs, the instruments will detail the medicines that pharmacists can substitute and any conditions that apply. Officials will develop instruments using the approach established for SSSNs.
The Pharmacy Guild of Australia welcomed the legislation. “Allowing pharmacists to substitute specific medicines without prior approval from the prescriber will go a long way in helping to ease pressure on doctors and help patients get faster access to alternative medicines when there is a serious scarcity,” George Tambassis, national president of the Guild, said.
Tambassis wants lawmakers to build on the platform provided by the legislation. The “next step is for the Government to allow the substituted medicines to be dispensed as pharmaceutical benefits so patients are not adversely affected by costs,” he said, noting that it is “critical that serious shortages are identified as early as possible so this process can be activated and the impact on patients minimized.”
TGA Notice, Guild Statement
India plans meeting to resolve long-running row over status of FDCs
An Indian regulatory subcommittee is planning to meet with companies affected by the proposed ban on irrational fixed-dose combinations (FDCs) to discuss their cases.
In May 2019, the subcommittee of the Drugs Technical Advisory Board (DTAB) asked manufacturers of some FDCs previously declared irrational to present “precise data” to support their products. The DTAB subcommittee gave manufacturers until the end of June 2019 to submit hard and soft copies of the requested information. Deadlines have been missed repeatedly throughout the FDC saga.
Last week, the DTAB advanced the effort to finalize the regulatory status of the FDCs by proposing to hold a video hearing with manufacturers. The hearing is planned for 19 April. Central Drugs Standard Control Organization (CDSCO) – DTAB’s parent organization – will provide updates about the schedule on its website.
CDSCO first moved to ban 344 FDCs deemed to lack the necessary safety and efficacy data years ago but has faced a drawn-out battle to try to fill the evidence gaps or finalize the regulatory status of the products.
CDSCO Notice
Philippine FDA finds COVID-19 test kits fall short of performance requirements
The Philippine Food and Drug Administration (FDA) has found 10 COVID-19 test kits fall short of their claimed specificity and sensitivity. FDA is advising caution in the purchase of kits including Abbott Panbio pending the start of recall proceedings.
Having fast-tracked the availability of COVID-19 tests, FDA imposed postmarket testing requirements through the Research Institute of Tropical Medicine (RITM). Tests have shown some COVID-19 antigen and antibody diagnostic products do not have the expected sensitivity and specificity.
Based on the RITM work, FDA issued a list of 10 products, some of which are provided by multiple marketing authorization holders, that “did not meet their declared product specificity and sensitivity after the performance validation conducted by [RITM].” An Abbott test for the qualitative detection of IgG and IgM antibodies was among the products listed by FDA.
The RITM results led FDA to state “caution should be observed in the purchase and use of said test kits pending initiation of product recall proceedings.”
FDA issued the notice days after posting a reminder that online sales of all types of COVID-19 tests are “strictly prohibited.” The agency has asked its regional offices to “conduct exhaustive monitoring of online platforms to ensure full compliance” with the ban on online sales.
FDA Notice, More
Pakistan’s DRAP seeks feedback on regulatory appeal guidelines
The Drug Regulatory Authority of Pakistan (DRAP) has released draft guidance on appealing licensing and registration decisions. 
Pakistanti law allows people who disagree with the decisions of the Central Licensing Board or the Registration Board to appeal to an Appellate Board. DRAP fleshed out the appeal process last week in draft guidance.
Aggrieved typically applicants have 60 days after a decision to file an appeal, although the exact time depends on which body issued the original ruling. For example, the guidance only gives applicants 30 days to appeal a decision of the Enlistment Evaluation Committee. Applicants can file a request for interim relief at the same time as appealing a decision by any board or committee.
Draft Guidelines


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