Asia-Pacific Roundup: Goa warns Abbott India over production plant involved in recall

India's Goa state has warned Abbott Laboratories that it plans to suspend the manufacturing license of a local facility. The situation stems from Abbott’s reporting of a potential quality incident to officials and a voluntary recall, and the company has begun implementing corrective measures to fix the problem.

Late last month, India’s Central Drugs Standard Control Organization (CDSCO) sent a notice about the voluntary recall of batches of certain Digene products, a brand of antacids sold by Abbott. The recall was triggered by a customer report that one bottle of Digene Gel Mint had a white color, bitter taste and pungent odor, unlike another bottle that had the regular sweet taste and light pink color.

After looking into the report, Abbott began a voluntary recall of one batch of its mint-flavored Digene and four batches of its orange-flavored product. The company subsequently expanded the recall to cover all batches of Digene in all flavors — mint, orange and mixed fruits — that are within their shelf lives and were made at the Goa facility.

“The impugned product may be unsafe, and its use may result in adverse reaction,” CDSCO wrote in its notice about the voluntary recall. Abbott told Reuters there is no impact on patient health.

CDSCO asked healthcare professionals to “carefully prescribe and educate their patients to discontinue the use” and report any adverse drug reactions. The agency also told consumers to stop using Digene Gel made at the Goa plant, advised wholesalers and distributors to remove products from their supply chains, and asked other regional regulatory officials to monitor the trade in the antacid.

Reuters followed up with a report, based on government documents, that India's Goa state has warned the local unit of Abbott Laboratories that it plans to suspend the antacid manufacturing license “after inspectors flagged contamination risks and sanitization issues at its factory.” Inspectors reportedly spent the last week of August at the plant and flagged issues such as water stagnation in tanks and pipes.

Considering the risk of contamination and microbial growth, the state director of the Goa Food and Drugs Department wrote to Abbott about his intent “to cancel the product permission for all variants of Digene Gel/suspend the licenses held by you for a period deemed fit.” Abbott is reportedly taking corrective measures to address diversions from standard operating procedures for sanitization.

Goa Notice, Reuters, More

TGA acts to mitigate impact of Sanofi recall on access to epilepsy treatment Sabril

Australia’s Therapeutic Goods Administration (TGA) has approved the substitution of different dosage forms of Sanofi’s epilepsy medicine Sabril (vigabatrin) to mitigate the impact of a recall on product availability.

Sanofi is recalling the tablet form of Sabril globally. Regulatory agencies in Canada and the UK have attributed the recall to the discovery of traces of tiapride, a drug used to treat a range of neurological and psychiatric disorders, in batches of the source material. The levels of tiapride in Sabril are significantly lower than the permitted threshold in adults but may pose a risk to children.

TGA learned about the recall and published a medicine shortage alert in August. Last week, the Australian regulator moved to mitigate the effect of the supply disruption by posting a Serious Scarcity Substitution Instrument. The instrument authorized pharmacists to provide oral sachets of Sabril to fill prescriptions for the tablet dosage form without prior approval from the prescriber, until the end of January.

The decision to provide the flexibility follows the earlier approval of Sabril tablets registered in the UK for temporary use in Australia. However, the recall affects the UK too, and TGA has warned that the supply of the overseas stock is “extremely limited.” Sanofi has advised TGA that there should be enough sachets of Sabril to meet demand in Australia until the tablet formulation returns to the market.

TGA Notice

HSA authorizes updated version of Pfizer’s COVID vaccine for use in Singapore

The Health Sciences Authority (HSA) has authorized an updated, omicron subvariant version of Comirnaty, the COVID-19 vaccine from Pfizer/BioNTech, for use in Singapore.

The updated product targets the XBB.1.5 variant, a form of omicron that became dominant earlier in the year.

“HSA had considered the extensive data accrued from the previous versions of Comirnaty Vaccine, as well as additional data which demonstrated that the updated vaccine could enhance the immune responses against the predominant circulating Omicron subvariants including XBB.1.5, EG.5 (Eris), as well as the emerging BA.2.86,” the authority wrote adding that the “overall evidence supported authorisation of the updated Comirnaty vaccine.”

HSA Notice

Philippine FDA seeks feedback on recognizing service providers for radiation dosimetry

The Philippine Food and Drug Administration (FDA) has released draft guidance on the recognition of accredited technical service providers for radiation dosimetry of individual monitoring services for public consultation.

Eleven months ago, FDA and the Philippine Nuclear Research Institute jointly hosted the International Atomic Energy Agency (IAEA) Occupational Radiation Protection Appraisal Service (ORPAS). The ORPAS team emphasized the importance of technical service providers in radiation protection and the need to have procedures for their authorization to comply with IAEA’s general safety requirements.

Now, FDA has released draft guidance on the recognition of technical service providers for radiation dosimetry of individual monitoring services used in radiation facilities and activities. The guidance applies to ionizing radiation facilities and activities under the jurisdiction of FDA.

In the draft, FDA states that it will only recognize technical service providers that are accredited by the Philippines or the International Laboratory Accreditation Cooperation (ILAC) for ISO/IEC 17025. FDA expects radiation facilities to check the Philippine and ILAC lists of conformity assessment bodies for accredited technical service providers.

FDA Draft

Malaysia’s MDA schedules meeting to understand the needs of the medtech industry

Malaysia’s Medical Device Authority (MDA) has arranged a meeting to gather industry feedback on the design and development of “regulatory programs, policies and engagement strategies for effective policy formulation and implementation.”

The meeting, which is scheduled for the morning of 26 September, will give up to 80 participants the chance to hear from MDA and provide feedback to help the authority understand their needs and the issues they face. MDA sees the meeting as a chance to provide effective regulatory advice and guidance that helps companies improve compliance and identify opportunities to support the industry.

At the meeting, representatives of MDA and the industry will present on topics such as the opportunities for growth available to local players from Malaysia and the potential to turn the country into a hub for medical device manufacturing. MDA has provided a form for attendees to use if they have questions or problems that they want the regulator to discuss at the event.

MDA Notice

Asia-Pacific Roundup: Goa warns Abbott India over production plant involved in recall

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