Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Posts Guidance on How to Manage and Communicate Drug Shortages
Australia’s Therapeutic Goods Administration (TGA) has posted guidance on the communication and management of drug shortages. The publication of the document comes five weeks before Australia makes the reporting of medicines shortages mandatory.
TGA proposed moving to a mandatory model in April after identifying “major failings” with its current drug shortage protocol. In the absence of mandatory reporting, some sponsors were failing to inform TGA of disruptions to supply. TGA only learned of these disruptions after they had begun to affect the availability of medicines. That lag prevented TGA from taking actions to mitigate the shortages.
Now, with mandatory reporting requirements set to come into force on 1 January, TGA has published guidance on the topic. The text fleshes out the ideas TGA presented in its consultation in April and tweaked in response to industry feedback two months later.
TGA’s guidance strongly advises sponsors to “develop effective internal procedures to ensure that they can comply with the mandatory reporting requirements, including reporting timeframes.” That focus reflects a disagreement between TGA and industry about what constitutes a reasonable length of time to report drug shortages.
Trade group Medicines Australia pushed back against the original timeframe and won a concession. TGA still expects sponsors to move quickly, though. Sponsors of medicines on TGA’s watch list have two working days to provide basic details of shortages, and another three working days to share the remaining required information.
The minimum information TGA expects to receive from sponsors through its Business Services (eBS) portal includes details of the nature and likely impact of the shortage, the anticipated duration of the supply disruption and contact details for the public and the agency.
Other sections of the guidance explain how to generate the requested information. For example, the guidance features an impact assessment framework to help sponsors assess the significance of their shortages. The framework assigns shortages an impact rating ranging from low to critical on the basis of the size of the patient population and availability of alternative treatments. The impact rating dictates how TGA and sponsors will respond to current and anticipated shortages.
TGA is applying the same framework to planned discontinuations of products. Despite resistance from industry, TGA has stuck to its original request to receive 12 months notice of discontinuations of medicines that have a critical impact rating or are on its watch list. If a sponsor is unable to provide that much notice, TGA expects to receive notification of the discontinuation as soon as possible.
The guidance forms part of a broader effort to prepare the industry for the implementation of the mandatory reporting requirements. TGA has also published responses to frequently asked questions about the changes, and is set to hold a webinar on the topic on 28 November.
, TGA FAQ
Indian Court Rejects Abbott’s Plea to Stop Probe into Alleged Diabetes Cartel
The Delhi High Court has rejected Abbott’s request to stop a Competition Commission of India (CCI) probe into alleged attempts to control the price of a diabetes drug. CCI wants to look into allegations that Abbott, Novartis, Emcure and USV collaborated to control the price of vildagliptin.
An anonymous whistleblower claiming to work at Abbott shared details of the alleged wrongdoing in 2016. Months later, the National Pharmaceutical Pricing Authority (NPPA) asked CCI to investigate the matter. CCI responded by asking the companies for information about their trade of vildagliptin, a dipeptidyl peptidase-4 inhibitor designed to prevent hyperglycemia in patients with type 2 diabetes.
In Abbott’s view, the whistleblower email that triggered the investigation is forged and the data cited by NPPA are inaccurate. That view has led Abbott to seek to get NPPA and CCI to change course, both by appealing directly to the agencies and by taking its case to the courts.
Neither route of objection has proven to be successful. The Delhi court found “no merit” in Abbott’s petition, adding that it was “not persuaded to accept any of the contentions advanced” by the company. That led the court to dismiss the case. CCI successfully argued against Abbott by stating its director general has the tools to assess the authenticity of the whistleblower email. CCI also argued that the dispute over the NPPA data centered on when, not if, price increases happened.
The ruling means CCI is free to investigate the allegations.
, The Economic Times
TGA Secures Philips’ Ongoing Support for Obsolete HeartStart MRx Defibrillator
Philips has entered into a memorandum of understanding with TGA. The agreement commits Philips to informing TGA of shortages related to the now-obsolete professional defibrillator HeartStart MRx through to the end of 2022.
TGA learned Philips planned to stop supplying the device in May 2017. Two months later, HeartStart MRx was removed from the Australian Register of Therapeutic Goods (ARTG).
That presented a potential problem. While Philips has dropped HeartStart MRx, the device is still in use at hospitals, private clinics and ambulance fleets across Australia. These organizations need the device to work so they can deliver life-saving electrical shocks to people in cardiac arrest and pace people with slow heartbeats.
To ensure devices already on the market function as intended, Philips has agreed to continue supporting the product line. If accessories, repair parts or consumables used by the device suffer shortages — or look likely to — Philips must tell TGA and work to fix the supply disruption as soon as possible. Philips is set to be freed from those commitments at the end of 2022.
Until then, Philips will meet with TGA twice a year and continue to report adverse events and near adverse events as if HeartStart MRx was still in the ARTG.
India Adds Disability Certificates to List of Materials Requested in J&J Compensation Case
India’s Central Drugs Standard Control Organization (CDSCO) has revised a compensation application form it created for people affected by Johnson & Johnson’s hip implants. The latest version features a request for a copy of disability certificates issued to people affected by the medical devices.
CDSCO published the previous version of the form two months ago to help a committee set up to assess compensation requests gather the information needed to inform its decisions. The revised version asks for all the information requested in the original form, plus a copy of a disability certificate.
The form states the certificate should be “issued by competent authorities as guided by Ministry of Social Justice and Empowerment.” The presence or otherwise of an official disability certificate will help the committee to decide if someone is due compensation, and if so, how much they will receive.
has published guidance on the regulation of menstrual cups. The publication of the guidance follows a change in the regulatory status of menstrual cups, which are now required to be listed in the ARTG. The guidance details the effect of the change on manufacturers, explains the regulatory requirements for menstrual cups and discusses post-marketing expectations. TGA Guidance
is recalling all batches of valsartan products Dilart and Dilart HCT from Australia
due to the presence of an impurity. The recall is the latest event in the multi-month investigation into the risk of N-nitrosodiethylamine contamination of valsartan. TGA Notice