Asia-Pacific Roundup: India’s CDSCO posts guidance on validating rapid infectious disease diagnostics

India’s Central Drugs Standard Control Organization (CDSCO) has published guidance on validating rapid diagnostics for pathogen identification and antimicrobial susceptibility testing.

The guidance, created with the Indian Council of Medical Research (ICMR), sets out “a comprehensive framework to systematically evaluate and confirm the diagnostic performance of a given test, ensuring its reliability and its utility for clinical decision making,” according to the agencies.

Rajiv Bahl, ICMR director general, framed the guidance as India’s response to the rise of antimicrobial resistance and the development of molecular techniques for identifying microorganisms and detecting drug-resistance genes. India has a “pressing need for high-quality, affordable diagnostic tools tailored to meet the specific requirements of the healthcare system,” Balh said. Molecular techniques could address the need, but the lack of a standardized framework for validation has impeded uptake, according to Bahl.

The protocol provides guidance on evaluating a test and showing its effectiveness. Companies that adhere to the standardized process can “expedite validation, reducing the time and steps required for regulatory approval,” Bahl said. He added that by bridging the gap between developers and regulatory bodies, the guidance could minimize delays and facilitate the timely introduction of tests into the Indian healthcare system.

The guidance includes “evaluation criteria for methods to detect, identify and quantify pathogenic microorganisms,” the agencies said, and methods for antimicrobial susceptibility testing. The collaborators have illustrated the steps to validate such diagnostic tests.

CDSCO and ICMR said the document will help companies “understand the kind of evidence required to be generated before approaching the validating laboratory and prepare for the validation process.” The document “delineates the steps in the pathway of regulatory approval for a test,” the agencies said.

CDSCO Guidance

Japan’s PMDA shares perspective on real-world data as an external control

Researchers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have published a paper on using real-world data and evidence (RWD/RWE) as an external control.

The research, published in the journal Clinical Pharmacology and Therapeutics, looks at eight recent examples of companies using RWD/RWE as an external control to win approval in Japan. Most of the approvals were for rare diseases, while two were for treating life-threatening cancers with limited therapeutic options.

The research team generated recommendations for companies that want to use RWD/RWE as an external control to support authorization in Japan. Drug developers should talk to PMDA at an early stage about the limitations of their RWD/RWE and their plan for the clinical data package, the researchers wrote, and should consider running a feasibility study.

“Conduct of a feasibility study may be useful for understanding the possible number of patients for comparisons and considering the limitations more appropriately, but examination of outcome itself and related indexes should be avoided to maintain scientific integrity of a study,” the authors said.

Drug developers should carefully consider the effects of potential biases and limitations, including those that are difficult to mitigate, at the planning stage of a study.

“Analytical methods including adjustment of confounding factors should be prespecified in a protocol for appropriate interpretation of study results,” the researchers wrote. “Any amendments of the protocol during a study should be clearly recorded and described.”

PMDA Paper

Hong Kong committee advises against universal RSV vaccination in seniors, pregnant women

Experts convened by the Hong Kong Department of Health have recommended against the universal use of respiratory syncytial virus (RSV) vaccines in seniors and pregnant women.

GSK and Pfizer have won approval for RSV vaccines in Hong Kong in recent years. GSK’s Arexvy was the first RSV vaccine approved in Hong Kong in 2023, but its approval was for seniors only. Pfizer’s Abrysvo was approved in 2024 for use in both seniors and pregnant women. When administered during pregnancy, Abrysvo is designed to protect babies from RSV after they are born.

Hong Kong’s Scientific Committee on Vaccine Preventable Diseases said data from overseas studies show the vaccines prevent RSV-associated lower respiratory tract disease among elderly persons. The experts also said the overseas data shows efficacy in preventing severe RSV-associated lower respiratory tract disease among infants born to vaccinated mothers for up to six months after birth.

However, the committee recommended against universal vaccination of either population. In seniors, the committee advised against universal use “pending specific recommendations from the [World Health Organization] and local data from the cost-benefit perspective.” In pregnant women, the experts want to see more safety data before recommending universal use of the vaccine.

“RSV vaccination did not show an increased risk for preterm birth but there was an observed increased risk of hypertensive disorders of pregnancy in a time-dependent model,” the experts said. “Post-marketing safety analysis is actively ongoing to further address safety concerns regarding the use of RSV vaccines in pregnant women.”

Press Release, Committee Report

Australia updates position on using whole live microorganisms as an active ingredient

The Australian government has published a notice about importing, supplying, and exporting medicines that contain whole live microorganisms.

Officials granted consent to trade the medicines under certain conditions. The government consent applies to products listed in the Australian Register of Therapeutic Goods and containing a whole live microorganism as an active ingredient. Export-only medicines and products that contain Arthrospira maxima or Arthrospira platensis are excluded from the consent.

Products covered by the consent must comply with relevant monographs in the British, European or US pharmacopeias or with a specific section of the Australian labeling requirements. Which documents a product complies with informs the labeling requirements. For example, compliance with the British or European pharmacopeias necessitates the inclusion of the name and potency of each strain on the label.

TGA Notice

New Zealand’s Medsafe flags safety concern with anti-CD20 drugs from Roche, Sandoz

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is monitoring the safety of anti-CD20 monoclonal antibodies sold by Roche and Sandoz.

Medsafe placed the potential safety concern on Roche’s Ocrevus, Gazyva and MabThera and Sandoz’s Riximyo, a biosimilar copy of MabThera, in response to international reports of pyoderma gangrenosum in recipients of anti-CD20 drugs. The rare inflammatory skin disease presents as a rapidly enlarging, very painful ulcer, Medsafe said.

Some other classes of prescription drugs can cause the disease. Attempts to understand if CD20 drugs can cause the condition are complicated by the fact some of the diseases treated by the medicines, such as rheumatoid arthritis, are associated with pyoderma gangrenosum.

The potential confounding and small number of cases led authorities in New Zealand to conclude the current evidence of a causal association between anti-CD20 antibodies and the condition is weak. Medsafe put a six-month potential safety concern on CD20 drugs to encourage reporting of events that could inform analyses of the risk.

Medsafe Notice

Asia-Pacific Roundup: India’s CDSCO posts guidance on validating rapid infectious disease diagnostics

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