Asia-Pacific Roundup: India health minister reviews drug, device regulations in push to raise standards
India’s minister of health, J.P. Nadda, has reviewed the regulation of drugs and medical devices to establish a “world-class regulatory framework matching our scale of operations and international expectations.”Nadda has focused on raising quality since re-taking office this year, using an early meeting to set out plans to upgrade all drug and medical device manufacturing plants to “world-class standards” over the next three years.
Nadda wants India’s Central Drugs Standard Control Organization (CDSCO) to lead efforts to raise standards, calling on CDSCO to create a roadmap with timelines for achieving global standards in its mandated activities. The health minister wants the “upscaling” to be “systems-based, focusing on highest standards of uniformity, technical upgradation and futuristic approach.”
“To achieve global standards, our focus needs to be on transparency of procedures at CDSCO and within the drugs and medical devices industry,” Nadda said. He wants the regulator and industry to work to the “highest principles of transparency” to ensure that products manufactured and sold by India meet “the highest indices of global quality standards.”
Nadda’s vision for how the agency can achieve that objective includes a continuous dialogue between CDSCO and the drug and device industries. He said that India should focus on developing mechanisms that make it easy for drugmakers to do business within the regulatory requirements, adding that CDSCO needs to be “user-friendly” and have “state-of-the-art facilities matching global standards.”
The export system should be “designed for proper intervention to maintain the quality of drugs being exported,” Nadda said, and the broader regulatory framework should reflect the needs of micro, small and medium enterprises. Nadda wants to understand smaller companies' issues and “support them to strengthen their capacity and quality of products on the one hand, and encourage them to meet the regulatory requirements on the other.”
Nadda was briefed about CDSCO's challenges related to aligning the roles and responsibilities of central and state drug regulatory bodies. He emphasized the need to work with states to enhance their skills and capacities and encourage them to align with the central government’s quality standards.
“This is especially important in view of upgradation of good manufacturing practices to global level embarked upon by CDSCO,” Nadda said.
Press Release
TGA seeks feedback on planned changes to standards for export-only medicines
Australia’s Therapeutic Goods Administration (TGA) has proposed changing its standards for export-only medicines as it prepares to sunset its existing legislation on the products.
The existing Therapeutic Goods Order (TGO) on export-only medicine standards expires on 1 October. TGA plans to replace the document with a new one that features changes intended to “expand options and increase flexibility for industry whilst safeguarding product safety and quality prior to export.”
Currently, the TGO refers to specific editions of international pharmacopeia that can serve as alternative standards for export-only medicines. Over the years, the TGA expanded the range of permissible standards, adding the US Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopoeia to the initial reference to the British Pharmacopoeia. Still, it retained the focus on specific editions.
In the latest update, TGA is proposing to remove references to specific editions of a standard or pharmacopeia. Instead, the TGO will refer to current editions of standards that are applied internationally within industry, freeing sponsors to use global product specifications for applications for export listings. The agency is also proposing formatting changes to clarify certain requirements.
TGA expects replacing the TGO “will be positive and welcomed by sponsors and industry.” The agency said the likely impacts include a more precise understanding for sponsors of the standards that can be used, reduced regulatory burden, improved alignment with international regulators' requirements, and a more fit-for-purpose TGO that keeps pace with medical advancements and drug discovery.
The draft is open for comment until 26 August.
TGA Notice
China creates a national working group to standardize healthcare security
China has set up a national working group to coordinate the creation of a list of national healthcare security standards.
The National Medical Products Administration (NMPA) of China shared details of the working group in an article that quoted Qu Hao, an expert on standards in the services sector at the State Administration for Market Regulation. Hao said the working group would provide a technical platform for standardizing security management services and treatments, pharmaceutical procurement, and fund supervision.
The project builds on the work of the National Healthcare Security Administration (NHSA), which has formulated and released 18 information coding standards since 2018. The standards apply to medical consumables, medical services and medicines covered by medical insurance.
Huang Huabo, deputy director of NHSA, listed cross-departmental sharing and mutual recognition of standardized data and standardizing and improving the supervision and evaluation mechanism among the next priority actions.
NMPA Notice
CDSCO proposes adding excipient information to barcodes, QR codes
CDSCO has proposed expanding the information companies should include on bar and QR codes.
The Drugs Rules, 1945 require manufacturers of certain drug formulation products to include a bar or QR code on the primary packaging label unless space constraints make inclusion on the secondary packaging viable. The current legislation lists eight pieces of information, such as the brand name and batch number, that manufacturers should store on the codes.
Recently, CDSCO proposed updating the legislation to add “details of excipients” to the information manufacturers should include in the codes. The proposal is open for comment, and “the draft rules shall be taken into consideration on or after the expiry of a period of 30 days” after publication.
CDSCO Notice
Inspection rejection prompts NMPA to stop imports of Daewoong Bio antibiotic
NMPA has suspended imports of an antibiotic made by Daewoong Bio after the Korean drugmaker rejected a request to inspect its manufacturing facility.
The agency wanted to visit the facility as part of its dynamic overseas production site inspection plan for 2024. However, Daewoong said in writing that it could not accept inspection as required, NMPA said, leading the agency to determine the company was not compliant.
The suspension applies to the import, sale and use of cefodizime sodium, a cephalosporin antibiotic, for injection. Separately, NMPA said it suspended imports and sales of Samo’s artificial knee joint system after a remote off-site inspection found fault with the Italian company’s compliance with Chinese regulatory requirements.
NMPA Notice (Chinese), Reuters
Other news:
Malaysia’s National Pharmaceutical Regulatory Agency (NRPA) has created a pre-membership module page for users to access its online forms. Unregistered users can visit the module page to access pre-membership online forms linked to the QUEST3+ online submission system. The page includes forms for full membership application and reporting adverse drug reactions. NPRA Notice
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