Regulatory Focus™ > News Articles > 2021 > 8 > Asia-Pacific Roundup: India starts probe into pricing of Chinese imports of atorvastatin intermediat

Asia-Pacific Roundup: India starts probe into pricing of Chinese imports of atorvastatin intermediate

Posted 10 August 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: India starts probe into pricing of Chinese imports of atorvastatin intermediate

The Indian government has begun an investigation into the pricing of Chinese imports of the ATS-8 intermediate used in the production of the cardiovascular disease drug atorvastatin.
 
Arch Pharmalabs, a manufacturer of intermediates including ATS-8, petitioned India’s Directorate General of Trade Remedies (DGTR) to carry out an anti-dumping investigation. Dumping is the trade practice of selling imported goods at below the value they command in their country of export. In this case, Chinese intermediate producers are accused of selling ATS-8 for less in India than at home.
 
As dumping puts local manufacturers at a disadvantage, governments impose anti-dumping rates to level the playing field. DGTR is now assessing whether Arch Pharmalabs is suffering “material injury” because of Chinese pricing practices and considering the imposition of an anti-dumping duty.
 
Arch Pharmalabs, which claims to be the only ATS-8 manufacturer in India, petitioned DGTR on the grounds that there is “significant price suppression, price underselling, low-capacity utilization and continued losses to the industry on account of the dumped imports.” The intermediate manufacturer made the accusation of dumping despite not having accurate information about the cost or price of ATS-8 in China. Arch Pharmalabs estimated the normal value in China based on its own costs.
 
DGTR’s first impression is that there is sufficient evidence of dumping, injury to Arch Pharmalabs and a causal link between the two to open an investigation. The investigation will seek to determine the existence, degree and effect of the alleged dumping and recommend an import duty that will stop Arch Pharmalabs from suffering further injury. DGTR will now spend one month gathering submissions about the subject.
 
DGTR Notice
 
TGA allows pharmacy-level substitution of Roche drug as COVID-19 stretches supply
 
The Therapeutic Goods Administration (TGA) is allowing pharmacists to substitute two versions of Roche’s Actemra amid Australian shortages created by use of the drug in COVID-19 patients.
 
Last month, the World Health Organization (WHO) issued a strong recommendation to use IL-6 receptor blockers including Actemra in people with severe or critical COVID-19. The recommendation came after WHO determined that there is high-quality evidence showing IL-6 inhibitors reduce mortality and the need for mechanical ventilation.
 
Weeks after the WHO recommendation, Roche told TGA that it faced shortages of multiple forms of Actemra that it expects to last into next year. Both the Actemra prefilled syringe and prefilled ACTPen autoinjector are expected to be in short supply at the patient level for six weeks.
 
TGA and other stakeholders have taken several actions in recent days to reduce the risk that people with rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and cytokine release syndrome will be unable to access Actemra because of demand from COVID-19 patients.
 
The actions include the publication of a Serious Scarcity Substitution Instrument (SSSI) that clears pharmacists to substitute the syringe and autoinjector versions of Actemra 162 mg/0.9 mL solution. Until the end of the year, pharmacists will be able to provide whichever version they have and then notify the prescriber of the substitution.
 
TGA began allowing pharmacy-level substitution of certain drugs in short supply last year. However, the scheme was only formalized and enshrined in law in March. Actemra is currently the only drug covered by an active SSSI.
 
TGA Notice
 
J&J gets emergency approval for COVID-19 vaccine in India
 
India has approved Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use. However, it is currently unclear when supplies of the vaccine will be available for use in the country.
 
Mansukh Mandaviya, the Indian Minister of Health and Family Welfare, disclosed the authorization on Twitter. The vaccine becomes the fifth COVID-19 prophylactic cleared for emergency use in India, although the experience of the fourth product raises questions about the impact of J&J’s clearance.
 
Moderna became the fourth company to win emergency approval in India, after AstraZeneca, Bharat Biotech and Russia's Gamaleya Institute, in June but its vaccine is yet to become part of the country’s vaccination campaign. The delay stems from the inability to reach an agreement over indemnity. India is reportedly unlikely to grant the legal protection sought by Moderna.
 
Pfizer is yet to win emergency approval in India, having been rebuffed early in the year, despite the country changing the evidence requirements for vaccines used overseas. J&J received clearance to sell its vaccine in India on the strength of its multinational pivotal clinical trial, the company told Reuters.
 
Mandaviya Post, Reuters
 
TGA defers down-scheduling decision on MDMA and psilocybin to allow review of evidence
 
TGA has deferred a decision on whether to down-schedule MDMA and psilocybin to enable a review of their therapeutic value, risks and benefits to take place.
 
In September, TGA began a consultation on whether to down-schedule MDMA and psilocybin from prohibited substances to controlled medicines. TGA received more than 1,000 responses to the two consultations. The agency made interim decisions not to down-schedule the molecules in February but delayed its final decision two months later, citing the need to seek further advice.
 
Now, TGA has tasked three independent experts with reviewing the clinical evidence on the roles that MDMA and psilocybin can play in the treatment of mental health conditions. The panel consists of a molecular pharmacologist with expertise in analgesics and psychoactive drugs, a psychiatrist and a professor in clinical and experimental pharmacology.
 
TGA expects to publish the panel’s report at the end of next month. The agency said the Advisory Committee on Medicines Scheduling will consider the report but gave no details of the timing of the final decision.
 
TGA Notice
 
Moderna wins provisional approval for COVID-19 vaccine in Australia
 
TGA has provisionally approved Moderna’s COVID-19 vaccine for use in Australia. The authorization positions Australia to administer 10 million doses of the mRNA vaccine due to be supplied this year.
 
Australia initially struck vaccine supply deals with AstraZeneca and Pfizer but added an agreement with Moderna in May. Moderna is contracted to supply Australia with 10 million doses of its original COVID-19 vaccine this year and 15 million doses of a version updated for variants in 2022.
 
TGA cleared a regulatory barrier to the use of the 10 million doses this week by granting emergency approval to the vaccine in adults. The agency said data on the use of the vaccine in adolescents is under evaluation and it will disclose a separate decision about the younger age group in three to four weeks’ time.
 
TGA Statement, More
 
Other News:
 
The Philippine Food and Drug Administration (FDA) has extended its interim guidelines on the registration of foreign drug manufacturers “until international travels return to normal.” FDA originally suspended foreign inspections and put in place alternative practices for one year. With the pandemic dragging on and cases in the Philippines rising quickly again, FDA has extended the temporary measures indefinitely. FDA Notice
 
TGA has published a Q&A on the conditions of supply for rapid antigen tests. The document sets out why TGA requires testing to be supervised by a health practitioner trained in sample collection and is opposed to the supply of home tests. TGA does allow rapid antigen tests to be supplied to medical practitioners who supervise sample collection via video. TGA Q&A

 

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