Asia-Pacific Roundup: TGA reopens consultation on IV potassium scheduling

Australia’s Therapeutic Goods Administration (TGA) has reopened its consultation on the scheduling of intravenous potassium “in recognition of the broad impact of the proposed changes.”

TGA shared its interim decision on the product's scheduling in December and gave people until 7 January to share feedback. Late last week, the agency resumed the consultation and reset the deadline for commenting to 18 March. TGA will consider all submissions received by the deadline before making a final decision.

The interim decision and its reasoning remain unchanged. TGA began investigating potassium salts after receiving a request to create a new prescription-only medicine entry for preparations given by injection or infusion. Such intravenous forms of potassium are currently unscheduled.

In response to the request, TGA proposed creating a prescription-only medicine entry for intravenous potassium salts. The agency plans to exempt from prescription-only status products with a concentration of less than 10 mmol per 100 mL of potassium and premixed infusion bags with a total amount of 25 mmol or less of potassium per bag.

TGA first proposed the new scheduling on 1 October, reflecting the agency’s belief that “further consultation on the potential impacts in the hospital setting should be sought.

Extending the consultation will give affected parties more time to comment on issues raised by the proposal, such as the potential to limit access to potassium to treat hypokalaemia, digitalis intoxication, and hypophosphatemia. TGA identified decreased access as an “unintended possibility” of increased prescriber oversight but feedback from a hospital pharmacy representative body allayed the concerns.

“In its view, it is not envisaged that a Schedule 4 listing for intravenous potassium salts will impede patient access or the established workflows of care in the hospital and health service environment, if reasonable steps are taken to ensure nurse practitioners can continue to prescribe and chart them in hospital settings,” TGA said. The body supported increased safety measures.

TGA said scheduling intravenous potassium as a prescription-only medicine would counter the “potential for administration in ‘wellness’ settings or as a hangover treatment.” If the product is left unscheduled, “there is a risk that untrained or unregistered people might purchase it for injection, which could result in infection-related deaths,” the agency said.

TGA cited problems with the use of high-dose vitamin C injections outside of hospitals as evidence that intravenous potassium could cause health issues unless oversight improves. The proposed inclusions and exemptions reflect evidence that total volume can contribute to the risk of adverse events and overly rapid infusion rate and incorrect medicine selection can have “catastrophic consequences.”

TGA Notice

India formalizes GMP extension

India’s Ministry of Health and Family Welfare has given small and medium-sized drugmakers three months to submit details of how they intend to comply with new good manufacturing practice (GMP) requirements.

The Central Drugs Standard Control Organization (CDSCO) published the revised GMPs in late 2023 and gave companies with turnovers of less than 2.5 billion rupees ($29 million) one year to comply. Last month, The Economic Times reported that half of the 10,000 drug manufacturing units in India may have missed the deadline and the government agreed to give companies more time (RELATED: Asia-Pacific Roundup, Regulatory Focus, 13 January 2025).

Starting from 11 February, companies have three months to submit their upgrade plans. Manufacturers that provide the information by the deadline will have until the end of 2025 to comply with the new GMP requirements.

CDSCO has created a form for companies to submit. Manufacturers need to include details of a gap analysis that addresses their plants, equipment, and other GMP elements, plus their plan for resolving the areas of non-compliance. Indian officials believe raising standards will make the country more competitive.

“The revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India,” the government said. “The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally.”

Press Release, Legislation

DRAP explains shelf-life rules for reference drugs imported for comparative testing

The requirement that imported drugs have 75% of their shelf life remaining does not apply to certain products needed for comparative testing, according to the Drug Regulatory Authority of Pakistan (DRAP).

The Pakistan Pharmaceutical Manufacturers’ Association wrote to DRAP late last year on the issue. DRAP’s response cited a 2018 meeting of its registration board where the board recommended allowing “the import of finished product (innovator's/reference) for performing comparative dissolution profile for submission of data with registration application,” DRAP said. Since then, customs officials have allowed the importation of reference drugs with a remaining shelf life of at least 75%.

DRAP also quoted regulations on the importation of small quantities of drugs for use in clinical trials and other studies. Neither those regulations nor an import policy order describes a restriction on the shelf life of imports. As such, DRAP said the 75% requirement does not apply to reference drugs imported for comparative dissolution and product development studies.

DRAP Notice

Philippine FDA doubles submission window for license to operate renewals

The Philippine Food and Drug Administration (FDA) has started accepting applications to renew operating licenses 180 days before they expire.

Previously, the application window opened 90 days before the expiration date. As an interim measure, FDA is accepting submissions within 180 days of a license’s expiration “to address the processing of renewal applications while providing adequate time for the stakeholders to process their authorization documents.” The agency framed the change as part of efforts to improve its service.

The interim, extended submission window will remain in place until further notice. FDA said, “The payment of the correct fee prior to the expiry of the [license] shall not result in surcharges notwithstanding the posting of payment.”

FDA Notice

Other news

Malaysia’s Medical Device Authority (MDA) has begun implementing regulations on the compounding of offenses. When a company commits a compoundable offense, MDA may offer to drop plans to prosecute if the business agrees to make a payment. Regulations published last year explain the process and list the offenses that can be resolved under the mechanism. MDA Notice

The Philippine FDA has published a recall notice about cefixime granules for suspension. The Cathay Drug Co. is voluntarily recalling the product “because the specific lots did not meet the required product specification based on the chemical assay tests performed by a third-party laboratory,” FDA said, which advised patients against using the affected products. Recall Notice

Malaysia’s MDA is running a customer satisfaction survey. The agency is collecting feedback until 25 February to inform efforts to improve its service. MDA Survey

Asia-Pacific Roundup: TGA reopens consultation on IV potassium scheduling

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