Under a World Trade Organization agreement, dumping is banned if it injures, or threatens to injure, the domestic industry in the importing country. Indian manufacturers Nectar Life Sciences and Sterile India claim imports of the ceftriaxone sodium sterile API meet the definition of dumping, leading DGFT to investigate.
The probe will seek to determine whether dumping is happening and, if so, what effects it is having on the Indian API industry. If DGFT finds evidence of dumping, it can recommend the Indian Finance Minister impose a levy on imports of the API. The size of the levy would depend on DGFT’s view on what it will take to create a level playing field for Indian ceftriaxone manufacturers.
Paperwork released by DGFT points to the challenges it will face in trying to determine whether the API is being sold at a price that qualifies as dumping. The applicants said the lack of manufacturers of the API outside of China and India makes it impossible to use the price in a third country as a guide. As such, the applicants have estimated the “normal value” of the API using knowledge of global raw material prices, the expenses of ingredient manufacturers and a 5% profit margin.
DGFT’s assessment of the normal value of the cephalosporin API will dictate what, if any, levy it recommends. The trade body will gather information from affected organizations for around the next month but has already seen enough evidence to think an investigation is necessary.
“The price underselling is significantly positive. Performance of the domestic industry has deteriorated in respect of various parameters such as capacity utilization, market share, profits, cash profits and return on capital employed. There is prima facie evidence that the dumped imports from subject country are causing material injury to the domestic industry,” the DGFT notice states.
DGFT will focus its investigation on the year leading up to April 2020, although its injury probe will also look as far back as the 2016-2017 financial year. The injury probe goes back to within two years of the last time DGFT looked at the dumping of cephalosporin. DGFT began looking into dumping of the API in 2007 and published its final findings in 2014.
The 2014 report, which was also triggered by an application from Nectar Life Sciences, claimed that Chinese manufacturers had engaged in “significant price undercutting” and that the Indian industry had suffered losses since 2010. DGFT recommended the imposition of an anti-dumping duty. Since the 2014 report, the Indian government has discussed plans to lessen the country’s reliance on API imports from China, including through the July proposal for the promotion of bulk drug parks.
DGFT Notice, 2014 Report
TGA seeks feedback on interpreting GMPs for compounded medicines
Australia’s Therapeutic Goods Administration (TGA) wants input on good manufacturing practices (GMPs) for compounded medicines via a consultation to get feedback on the changes it plans to make in response to its adoption of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to GMP PE009-14.
TGA developed the current GMP guidance, which was finalized after a consultation in 2015, to help producers of compounded and dispensed therapeutic goods interpret an earlier PIC/S guide. Since then, TGA has adopted the PIC/S Guide to GMP PE009-14 and identified areas in which its existing guidance is lacking, leading it to release the third version of the document for consultation last week.
The new version differs significantly from its predecessor. Many of the changes proposed by TGA are intended to “align with contemporary expectations.” Other planned revisions are more specific.
TGA highlighted the product expiry of compounded medicinal products as a specific area in which it has sought to provide additional guidance. Expiry dates are addressed in the existing guidance, but the topic is covered in more detail in the new draft, which features subsections on topics such as the special considerations affecting expiry dates for compounded biological medicines.
Other specific changes include the addition of details about dose administration aids (DAAs), a topic absent from the current guidance. The new section outlines the state and territory requirements that can apply to DAA manufacturers and automated and semi-automated dose packaging systems they use.
TGA is accepting feedback on the draft until 18 December.
Australia fines face mask importers $59,000 in relation to COVID-19
TGA has fined importers of medical face masks AU$82,584 ($59,382), with Sydney Tools receiving the largest fine, AU$26,640, for allegedly importing face masks that at the time were neither included in the Australian Register of Therapeutic Goods (ARTG) nor destined for the National Medical Stockpile.
Early in the pandemic, Australia exempted importers from the need to get face masks added to the ARTG if they were bringing products into the country to supply the national stockpile. However, TGA has identified companies that allegedly unlawfully imported face masks into the country. Sydney Tools and the other companies hit by the flurry of fines lacked contracts with the government.
TGA said it is helping importers not covered by the exemption to get their face masks added to the ARTG. The agency, which has stepped up its advertising enforcement activity during the pandemic, highlighted guidance on the face masks and respirators under its purview.
TGA Notice, More
China’s CDE starts consultations on cell therapy development
China’s Center for Drug Evaluation (CDE) has released draft cell therapy guidelines for consultation. The two documents cover development of immune cell therapies and gene transfer.
In developing the guidelines, CDE has drawn on the work of its international peers, leading to texts that address topics such as process development, quality control and the design of viral vectors. The release of the guidelines is the latest in a series of updates affecting the regulation of cell and gene therapies issued by bodies including CDE and China’s National Institute for Food and Drug Inspection in recent years.
CDE is accepting feedback on the drafts until 30 October.
CDE Notice, More
TGA signals end of expedited labelling pathway opened amid COVID-19
TGA is set to close an expedited pathway for companies seeking to supply medicines without TGO 91 compliant labels on 9 October. The standard pathway will remain open.
Australia was due to switch from TGO 69 to TGO 91 at the start of September. However, companies told TGA they had encountered problems when trying to introduce TGO 91 assessed labels. In light of the difficulties, which the companies attributed to COVID-19, TGA set up an expedited pathway for manufacturers that were yet to swap approved TGO 91 labels for approved TGO 69 labels.
TGA disclosed the pathway in June. Last week, TGA said the pathway will close on 9 October. Companies that want consent to supply products with noncompliant labels after that date will need to use the standard section 14 process.