Regulatory Focus™ > News Articles > 2021 > 7 > Asia-Pacific Roundup: AstraZeneca fights accusation of Tagrisso overcharging in India

Asia-Pacific Roundup: AstraZeneca fights accusation of Tagrisso overcharging in India

Posted 06 July 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: AstraZeneca fights accusation of Tagrisso overcharging in India

AstraZeneca has begun a legal challenge against a demand by India's National Pharmaceutical Pricing Authority (NPPA) for payment in relation to alleged overcharging. NPPA has accused AstraZeneca of overcharging for cancer drug Tagrisso by more than $2 million from March 2019 to January 2021.
 
The root of the dispute dates back to February 2019, when the Indian government capped the trade margins on 42 oncology medicines. Osimertinib, the active ingredient in Tagrisso, was one of the 42 treatments covered by the order. The molecules in Novartis’ Afinitor, Pfizer’s Sutent and Roche’s Avastin were also affected by the order, which cut the price of medicines by as much as 87%.
 
AstraZeneca contends that osimertinib is outside the scope of the order and the Drugs (Price Control) Order, 2013 as it is a patented molecule. However, NPPA is still applying the price order to the EGFR tyrosine kinase inhibitor.
 
NPPA has alleged AstraZeneca has violated the order and overcharged by almost Rs. 1.6 billion ($2.1 million). In a notice received by AstraZeneca on 25 June, NPPA asked the company to pay the amount it allegedly overcharged within 30 days. NPPA said AstraZeneca is also liable for interest.
 
AstraZeneca is challenging the NPPA demand. In a financial regulatory disclosure, AstraZeneca said it “strongly believes that the NPPA has not adequately considered several submissions made in support of the Company’s contentions.” Having evaluated its legal position, AstraZeneca concluded the NPPA demand “is grossly erroneous and legally unsustainable.” AstraZeneca disputes the calculation, too.
 
“The notice penalises the Company for supplying at lower rate to government institutions vide tenders as compared to maximum retail price {MRP} and yet for purposes of accounting erroneously included the MRP and not the amount actually realized,” AstraZeneca wrote.
 
AstraZeneca has challenged the demand in the High Court of Delhi. As AstraZeneca sees it, the case has implications beyond Tagrisso. AstraZeneca said the order “may have Industry wide implications on patient assistance programs,” such as its own initiative to help people who pay out of pocket, and could therefore affect the affordability of medicines for some individuals.
 
AstraZeneca Statement
 
TGA sees support for a mandatory timeframe for medical device adverse event reports
 
Australia’s Therapeutic Goods Administration (TGA) has found support for the implementation of a mandatory timeframe for the submission of final medical device adverse event reports. TGA is now holding follow-up discussions on some of the proposals to inform regulatory drafting decisions.
 
Last year, TGA held a consultation on five proposed enhancements to adverse event reporting for medical devices. The consultation drew 112 responses, more than two-thirds of which were filed by medical device manufacturers or sponsors. TGA recently shared a summary and analysis of feedback it received.
 
The consultation revealed most industry respondents support the implementation of a mandatory timeframe to file the final adverse event report of up to 120 days from the time of submission of the initial report. Some respondents asked for a provision that enables TGA to approve an extension or an interim report when a company cannot prepare a final report within the mandatory timeframe. TGA said the feedback indicated a need to raise consumer awareness about adverse event reporting.
 
Two other proposals received the support of most industry respondents. TGA saw support for the implementation of audits of sponsor activities and premises to validate their postmarket surveillance obligations. Most industry respondents identified a need to educate and promote better regulatory compliance among sponsors.
 
TGA also saw industry support for the adoption of the postmarket definition used in the European Union Medical Device Regulations. The support reflects a belief that the fact the terms are used but not defined in Australian legislation results in ambiguity, subjectivity and inconsistency.
 
The industry opposed the removal of all eight of the exemption rules to reporting adverse events over concerns about increased administrative burden. However, there was industry support for the removal or rewording of some of the exemptions. Finally, industry respondents said they are adequately informed about medical device issues and do not need enhanced communication. TGA did see an opportunity to improve the understanding of healthcare providers and consumers.
 
Based on the consultation and follow-up discussions, TGA will provide feedback to the Minister of Health. The feedback could inform the policy of the Australian government and regulatory drafting decisions.
 
TGA Notice, Feedback Summary
 
India designates two central laboratories for COVID-19 vaccines to support supply
 
The Indian government is designating two more sites to handle batch testing and quality control for COVID-19 vaccines. Officials took the action to accelerate the testing and pre-release certification of vaccines.
 
India has relied on the Central Drugs Laboratory (CDL) at Kasauli for testing and pre-release so far, reflecting the site's status as the National Control Laboratory for human vaccines. With India in the middle of a huge vaccination campaign that has so far given 358 million people at least one dose, the government has identified a need for more capacity.
 
The National Centre for Cell Science (NCCS) in Pune was designated as a CDL for COVID-19 vaccines last week. The government expects the National Institute of Animal Biotechnology (NIAB) in Hyderabad to receive the designation shortly.
 
NCCS and NIAB are poised to join the vaccine testing effort as the result of investment in capacity to handle the work. The government expects the two sites to process around 60 batches of vaccines a month. Officials picked the facilities in part due to their proximity to vaccine manufacturing hubs. The Serum Institute of India, which is manufacturing the Oxford-AstraZeneca jab, works out of Pune.
 
Press Release, Gazette Notification
 
Malaysia’s MDA updates guidelines for testing medical face masks
 
Malaysia’s Medical Device Authority (MDA) has updated its guidelines for the testing of medical face masks in response to the COVID-19 pandemic.
 
The requirements, which MDA communicated in written guidance and an infographic, describes the different types of medical face masks and respirators and their labeling requirements. MDA also used the guidelines to set minimum performance and testing requirements based on resources from bodies such as ASTM International and the European Committee for Standardization.
 
MDA wants manufacturers to refer to the guidance when registering a medical face mask and respirator. The agency has also created a tool which healthcare facilities and the public can use to check the registration of a face mask. 
 
MDA Notice (Malaysian)
 
Australian fecal microbiota transplant products regulation takes effect
 
New regulatory requirements for fecal microbiota transplant (FMT) products have come into force in Australia. TGA set out the implications of the 1 July change to FMT regulation in a notice.
 
With the 18-month transition period now over, FMT products need to be included in the Australian Register of Therapeutic Goods (ARTG) to be supplied. The only exceptions are FMT products that are supplied under a pathway for unapproved products, such as in clinical trials, and products that were submitted for inclusion in the ARTG on or before 30 June and are pending a TGA decision.
 
The changes mean Australian gastroenterologists and infectious disease specialists can only source FMT products from TGA-approved providers or manufacturers. The products will be treated as Class 1 or Class 2 biologicals for regulatory purposes.
 
TGA Notice

 

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