Asia-Pacific Roundup: India proposes immediate license suspensions for manufacturers of substandard drugs
The Indian government has proposed immediately suspending the license of any company that produces a drug that is not of standard quality.
Under the planned change to the Drugs Rules, 1945, the central or state licensing authority will suspend manufacturing licenses upon receipt of a certificate of test or analysis indicating that the drug is not of standard quality with respect to assay, dissolution, related substances, impurity, or sterility tests.
Licenses will remain suspended until the manufacturer completes an effective root cause analysis and implements the corrective and preventive action (CAPA) plan to the licensing authority’s satisfaction. Authorities will verify CAPA implementation before revoking suspensions. The proposals empower central licensing authorities to seek details of root cause analysis, CAPA plans, investigational reports, and the final action taken by their state counterparts to ensure compliance with the requirements.
The government called the proposals “a significant step towards strengthening the regulatory framework for ensuring the quality and safety of medicines in the country.” The significance of the proposed rules reflects the potential to enable prompt regulatory intervention to prevent the continued production of medicines declared not of standard quality (NSQ) on specified critical quality parameters.
Under the current process, authorities suspend or cancel manufacturing licenses after working through a prescribed regulatory procedure, including issuing a show cause notice. The procedure can create a gap between declaring a drug NSQ and starting regulatory action. During the gap, the product may remain on sale, posing potential risks to public health and complicating the recall process.
The government proposed the changes alongside planned amendments to the test report form. Under the proposed changes, the Drugs Controller General of India, the relevant state licensing authority, and the manufacturer and marketer of the affected drug will receive copies of the government analyst’s test report.
By sending the report to relevant authorities and stakeholders, the government aims to ensure timely communication of NSQ findings and facilitate coordinated regulatory action. The goal is to strengthen accountability across the manufacturing and marketing chain. Officials expect the reformed legislation to reinforce public confidence in the quality of medicines sold in India.
The government is seeking feedback on the proposals for 30 days.
Japan’s PMDA posts basic principles for using artificial intelligence in regulatory activities
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared principles for promoting the responsible use and development of artificial intelligence (AI) in activities involving regulatory judgment and decision-making.
The document, part of PMDA’s “early consideration” series, covers the use of AI across the lifecycle of pharmaceuticals, medical devices, and other health products. PMDA has created the document to help its staff, marketing authorization holders, manufacturers, sponsors, contract research organizations, and other companies involved in activities concerning regulatory judgment and decision-making.
PMDA set out a three-tier structure for maximizing the benefits of AI while appropriately managing risks that may arise from its use in regulatory activities. The first tier is the human-centric principle, which states that AI is intended to support, rather than replace, human judgment and decision-making.
The second tier features six core principles. One core principle states that companies using or developing AI should estimate the level of risk based on the probability and severity of undesirable events and implement appropriate mitigation measures. Other core principles cover the need to avoid undue bias in AI outputs and to establish appropriate governance and management processes.
PMDA’s third tier features five implementation and management principles. The principles address the need to align AI with the intended use and scope, to complete performance assessment and validation prior to use, and to continuously monitor and evaluate technologies after they come to market. It is important to continuously improve understanding of the characteristics and limitations of AI to maintain effective human oversight, PMDA said.
The five-page document covers key considerations that warrant particular attention. PMDA also expects companies to address organizational governance, operational frameworks, and other generally applicable requirements, regardless of whether they are described in the AI document. The agency will review and update the document as necessary.
India floats changes to rules on qualified persons and microbial monitoring requirements
The Indian government has proposed establishing new requirements for qualified persons for drug batch release and aligning microbial monitoring requirements with international guidelines.
Under the batch release proposal, manufacturers will need to designate a suitably qualified and experienced person for the activity. Currently, licensed manufacturers must provide details of competent technical staff responsible for monitoring and testing, but no equivalent provision applies to the person authorized to undertake batch release.
The government wants to change the rules to strengthen accountability in drug manufacturing. Imposing the requirements will establish clear responsibility for batch release, ensure traceability of decisions, and provide an additional level of oversight of product quality, the government said. Officials are also seeking feedback on a prescribed format for the batch release certificate.
One day after disclosing the proposals, the government published details of planned revisions to the limits for microbial contamination in Grade A clean areas, which are critical to sterile drug manufacturing. The government plans to align its limits with a World Health Organization (WHO) document.
Harmonizing Indian requirements with the WHO guidelines will strengthen the regulatory framework governing sterile pharmaceutical manufacturing and make the detection of microbial growth in Grade A areas a trigger for investigation, the government said.
Malaysia’s MDA seeks feedback on updated medical device distribution record guidance
Malaysia’s Medical Device Authority (MDA) is holding a consultation on planned changes to its guidance on medical device distribution records.
Under Malaysian medical device regulations, licensees must establish procedures for managing and maintaining comprehensive distribution records. The rule reflects the potential for elements of the distribution process, such as storage conditions, to affect the integrity of medical devices. MDA published guidance on the content, maintenance, retention, and control of the records in 2020.
The draft second edition of the guidance features clarifications of the document’s scope. MDA has also added new definitions, including for “distributor” and “field corrective action,” and updated details of the contents, maintenance, retention, and control of distribution records.
Other changes include enhanced traceability requirements for implantable medical devices, for example through tracking at the level of healthcare facilities and patients. MDA has proposed additional obligations for establishments to comply with distribution record requirements.
The agency is accepting feedback on the draft until 18 November.
Other News:
The Indian government has proposed expanding the network of authorized entry points for imports of drugs and medical devices. Indian law restricts imports of the products to authorized ports, airports, railway stations, road crossings, and other entry points. Seeking to facilitate trade, the government has proposed adding new locations to the list of authorized entry points. Press Release
The Drug Regulatory Authority of Pakistan (DRAP) has updated its guideline for the lot release of human vaccines, blood products, and antisera. The guideline covers the responsibilities of different stakeholders and the procedure that registration holders should follow. DRAP Guideline
Australia’s Therapeutic Goods Administration (TGA) has found that Synedica Retatrutide 10-mg products contained less retatrutide than stated on the label. Retatrutide is an investigational weight-loss drug in development at Eli Lilly. TGA Notice
