Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Indian High Court Stays Profiteering Proceedings Against Abbott
The Delhi High Court has hit pause on anti-profiteering proceedings against Abbott. The ruling frees Abbott from the need to pay a fine imposed by the National Anti-Profiteering Authority (NAPA) while the constitutional validity of the punishment is considered.
NAPA fined Abbott Rs 96.59 lakh ($137,000) in early March over a goods and services tax (GST). The anti-profiteering body took the action after finding Abbott had failed to pass the benefits of a change in GST onto consumers. The fine related to the pricing of a single product — Melaglow Rich — but NAPA planned to expand the investigation to cover all Abbott’s portfolio after reaching its verdict.
Now, the high court has thrown the case against Abbott into doubt. Abbott appealed the NAPA ruling on various grounds, including a challenge to its constitutional validity. The company also pushed back against NAPA’s plans to investigate other products, arguing that it is beyond the agency’s powers. Abbott’s legal team said the company tried to reach an agreement with the agency “on the basis that there would be no further investigation by the NAPA and no further penalty.”
The arguments persuaded the high court to order a stay of further proceedings against Abbott and set aside six weeks for people to file replies to its action.
Companies other than Abbott could benefit from the decision. The high court order notes that other companies have made arguments similar to Abbott’s, and observers think these challenges may now have a chance of success. Harpreet Singh, partner at consulting firm KPMG, told local media the ruling provides “an opportunity for all dealers to consider filing a letter with anti-profiteering authorities pleading that their proceedings should be stayed till the time the issue surrounding constitutional validity is settled by courts.”
Pratik Jain, national leader, indirect taxes at PwC, also weighed in on the case, noting that NAPA’s hopes of using GST cases against single products as a springboard for company-wide investigations may now be in trouble.
“This is another case where courts have indicated that ambit of anti-profiteering should be limited to the product under question and not extended to entity as a whole,” Jain said.
, The Times of India
, The Economic Times
Singapore Updates Breast Implant Advice, Discusses Ban of Allergan Device
Singapore’s Health Sciences Authority (HSA) has updated its advice on the management of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). HSA banned the sale of Allergan’s Natrelle breast implant last month and is monitoring the safety of other devices.
Like other regulators, HSA has reconsidered its position on the safety of textured breast implants in light of reports of BIA-ALCL and the actions taken by its peers in other countries to counter the safety concerns. As Allergan’s Natrelle is the only macro-textured breast implant available in Singapore, HSA has focused on the safety of the device, leading to a ban on its sale last month. An expert panel set up by HSA in February supported the ban.
The action leaves seven other brands of breast implant on the market. HSA is continuing to monitor and review local and global developments but has opted against taking further action at this time.
That position is underpinned by the findings of the expert committee, which ruled that while the data suggest textured breast implants pose a greater risk than smooth devices, the risk factors linked to BIA-ALCL remain unclear. HSA’s position is in line with those of regulators in countries including Australia and Switzerland, which have identified gaps in the data and the mechanistic understanding of the disease.
HSA thinks the best plan, for now, is to ensure cases of BIA-ALCL are detected quickly and treated appropriately. With that in mind, HSA has advised people with breast implants to regularly inspect their breasts for signs of swelling, lumps or pain.
China’s Drug Regulator Tightens Ties to Agencies in Hong Kong and Macau
China’s National Medical Products Administration (NMPA) has signed a cooperation agreement with its counterparts in Hong Kong and Macau. The agreement positions the agencies to share regulatory information and cooperate on standards.
Chinese officials framed the agreement as a continuation of the “one country, two systems” approach it began to pursue in the 1980s to reunify the country without imposing economic and administrative systems on Hong Kong and Macau. The model led Macau and, particularly, Hong Kong to develop standalone regulatory systems.
Now, NMPA wants to deepen its cooperation with the neighboring medicine regulatory agencies. The statement to disclose the news highlights personnel training, recalls, safety alerts and the exchange of regulatory information as areas covered by the agreement.
uMPA also said meeting with officials from Hong Kong and Macao gave it a chance to hear their views on China’s plans to create a Greater Bay Area that will involve all three territories. The plans for the development include the creation of a science and technology innovation center.
India Appoints Chief Vigilance Officer to Tackle Corruption at Pharma Department
India’s Department of Pharmaceuticals (DoP) has named Hara Kumar Hajong as its chief vigilance officer (CVO). The appointment puts Hajong in charge of preventing and detecting corruption and malpractice at the department.
The Central Vigilance Commission (CVC) of India appoints CVOs to serve as its “extended hands” in each government department. CVOs, who are typically hired from outside the department, work to prevent corruption and malpractice by improving rules and procedures, monitoring parts of the organization that are susceptible to wrongdoing and running inspections to find system failures.
Hajong will serve this function at DoP, at least for the next three months. The part-time appointment will see Hajong serve as CVO and be the main contact for all DoP vigilance matters while continuing to perform his current functions.
DoP brought Hajong on board to serve as an economic advisor earlier this year. Hajong has worked at the Indian Economic Service for more than 20 years and specialized in economics at university.
has issued a notice about 23 batches of drugs that failed to meet its testing requirements. The drugs include paclitaxel injections made by Shanxi Zhendong Taisheng Pharmaceutical and Harbin Pharmaceutical Bioengineering that NMPA inspected for visible foreign objects. NMPA has tasked the affected organizations with recalling their drugs and rectifying the problems. NMPA Notice
has seized illegally manufactured codeine and other drugs with a claimed street value of S$53,000 ($39,000). The seizure included 80,000 liters of codeine cough syrup and 32,000 tablets containing various active ingredients, including midazolam, nitrazepam and diazepam. The drugs were sold out of a coffee shop and manufactured at a nearby apartment. HSA Statement
has approved a a long-acting GLP-1 receptor agonist for use in the treatment of Type 2 diabetes. The drug is designed to help adult diabetics improve glycemic control, either alone or in combination with metformin. Around 10% of Chinese adults are diabetic, and many more have prediabetes. NMPA Notice
The New Zealand Medicines and Medical Devices Safety Authority
(Medsafe) is reviewing the risks and benefits of Cafergot, a migraine treatment supplied by AFT Pharmaceuticals
that combines ergotamine tartrate and caffeine. Medsafe Notice