Asia-Pacific Roundup: India establishes tougher penalties for filing misleading or fake documents
The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.
Previously, Indian law permitted authorities to reject applications featuring misleading, fake, or fabricated documents and to cancel the applicant’s existing licenses. Seeking to align India’s regulatory framework with global best practices, the government identified a need to strengthen the penalties for seeking approval based on fake or fabricated data.
“Submission of fake or fabricated data compromises the integrity of the regulatory process, casts aspersions over the quality of drugs, and may pose serious risks to public health,” the government said. “The present amendment is intended to deter such misconduct, strengthen accountability among applicants, and ensure that approvals of drugs are backed by reliable and scientifically valid evidence.”
The government, which sought feedback on its plans in October, has notified amendments to the Drugs Rules, 1945. The update adds a definition for “debarment” and establishes a process for when and how authorities will use the punishment.
Under the new legislation, debarment means “the prohibition, exclusion, or disqualification of any person, firm, or entity from engaging in the import of drugs, manufacture for sale or for distribution, sell, stock or exhibit or offer for sale, or distribute, for a specified period or permanently as a consequence to the violation of statutory provisions.”
The definition was absent from the draft proposals released for consultation last year. The rest of the text is largely unchanged from the draft, with both the provisional and notified versions inserting one or two paragraphs about debarment in seven parts of the existing legislation.
All the additions include a paragraph stating that applicants found guilty of submitting misleading, fake, or fabricated documents or information will be given a chance to argue against debarment. If those arguments fail to persuade the regulator, the licensing authority will debar the applicant “for such period as may be deemed fit.”
Six of the seven additions include a second paragraph about the appeals process. If an applicant is aggrieved by their debarment, they can submit an appeal to the government within 30 days of receiving the punishment. The government will make “such enquiry as it considers necessary” and give the applicant the chance to be heard before passing “such orders as may be considered appropriate.”
The changes are intended to promote regulatory compliant drug manufacturers and distributors while dealing with reported instances of malpractice, the government said. Officials see the legislative updates as complementary to ongoing reforms of pharmaceutical regulations designed to enhance oversight, promote ethical practices, and ensure that “unscrupulous entities are adequately penalized.”
Press Release, Gazette Notification
New Zealand’s Medsafe extends general labeling exemption to more drug products
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has extended the general labeling exemption to more types of drugs and product packaging.
New Zealand law allows the Director-General of Health to exempt manufacturers of medicines in certain types of containers from complying with labeling requirements. Exemptions are typically granted for up to two years. However, medical gases receive lifetime dispensations through a process called the general labeling exemption.
After an internal review and risk assessment, Medsafe has extended the general labeling exemption to 10 types of medicine and product packaging beyond medical gases. The list of newly exempt products includes personalized prescription medicines and general sale parenteral solutions or injections given under the care of healthcare professionals. Multivalent vaccines, whole blood, and blood components are also exempt, as are fixed-dose combination products subject to certain labeling space constraints.
Intermediate and transparent packaging is now covered by the general labeling exemption, which also extends to sample or starter packs and certain single- and multi-dose small containers. Controlled drugs or related products are not eligible for a general labeling exemption.
Medsafe updated its labeling guidance to reflect the changes, which take effect on 11 August. Sponsors of products currently covered by time-limited exemptions do not need to do anything. Their exemptions will remain valid until expiry, at which point the general labeling exemption will take effect. Some sponsors may need to update their labels to benefit from the general exemption. Medsafe evaluators of pending filings for time-limited dispensations will apply the general exemption when applicable.
CDSCO schedules consultation on single ethics review for multi-center studies in India
The Central Drugs Standard Control Organization (CDSCO) has arranged a consultation meeting for 25 August to discuss the introduction of single ethics reviews of multi-center studies in India.
In March, the Indian Council of Medical Research (ICMR) outlined plans for clinical trial sites to choose one ethics committee to review the study protocol. ICMR framed the proposal to streamline the study startup process. Earlier attempts to streamline the process, which ICMR put forward in 2017 and 2023, were undermined by operational and logistical constraints that limited adoption.
Four months after ICMR published final operational guidelines for single ethics reviews, CDSCO has set up a meeting to receive feedback on the implementation of the proposals. The regulator has invited drug developers, contract research organizations, and other groups affected by the guidelines to the meeting. Companies can nominate representatives to participate in person or via an online platform.
Malaysia implements hologram security labels to strengthen medical device oversight
Malaysia’s Ministry of Health has proposed the phased implementation of hologram security labels for registered medical devices.
The proposal is “a strategic initiative to strengthen post-market regulatory oversight, enhance the integrity of the medical device supply chain, and protect consumers from the risks associated with counterfeit and unregistered medical devices,” Malaysia’s Medical Device Authority (MDA) said. Consumers will use the labels to identify medical devices that are registered with MDA.
Malaysia’s Minister of Health will officially announce the implementation of hologram labels at an event on 26 August. The government has yet to provide a timeline for implementation, although its references to “phases” and plans to “progressively expand” the program suggest a staggered transition.
The proposals build on decades of use of the Farmatag hologram security label for pharmaceutical products. The labels, which Malaysia introduced in 2005, have helped identify registered products and combat counterfeits, MDA said. Experience with Farmatag forms the foundation for expanding hologram labels to medical devices.
Other News:
Australia’s Therapeutic Goods Administration (TGA) has started a review of the benefits and risks of Amgen’s Tavneos. The drug, which treats the rare autoimmune disorder ANCA-associated vasculitis, has been the subject of global regulatory scrutiny amid concerns about the integrity of the pivotal trial that supported approval. European authorities recommended revoking Tavneos’ approval in June. TGA Notice
The World Health Organization’s South-East Asia Regulatory Network has recognized the Indian Pharmacopoeia Commission as the regional center of excellence in pharmacovigilance and the technical center in quality. The recognition reflects contributions to strengthening pharmacovigilance systems, advancing pharmaceutical quality standards, and building regulatory capacity. Press Release
TGA has sued Better Leaf, Better Life Aussie, and their sole director Jack Weisberg over alleged unlawful advertising of medicinal cannabis. TGA took legal action after issuing repeated warnings to the companies, as well as multiple infringement notices to the companies and Weisberg that went unpaid. The agency alleges that the companies promote cannabis for treating serious diseases. TGA Notice
