Asia-Pacific Roundup: India’s CDSCO meets WHO international standards for vaccine regulations

India’s Central Drugs Standard Control Organization (CDSCO) has met the World Health Organization’s (WHO) published indicators for a functional vaccine regulatory system.

In 2017, a team of international experts led by WHO reviewed India’s vaccine regulatory system. The team ruled India met the published indicators for a functional vaccine system. India achieved maturity level 4, the highest rank, for several functions such as clinical trial oversight, marketing authorization, vigilance, lab access and lot release and maturity level 3 for the remaining four functions.

Since then, WHO has updated its Global Benchmarking Tool. India’s Ministry of Health and Family Welfare said version VI of the tool has “raised bars and stringency in benchmarking criteria.” A paper by experts from USAID Medicines, Technologies, and Pharmaceutical Services called WHO’s version VI the “first globally accepted tool for objectively assessing and strengthening regulatory capacity.”

A team of international experts assessed India’s vaccine regulatory system against version VI of the tool in September. India’s health ministry said the country “retains maturity level 3 with highest marks in several functions.” Roderico Ofrin, WHO representative to India, added that “this is indeed a great achievement” in a statement published by the health ministry.

The WHO experts evaluated the general framework for the system and specific regulatory functions including registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, inspections, laboratory testing, clinical trial oversight and lot release. As part of the review, WHO’s team has created a plan featuring activities India can take to strengthen its system.

Receiving maturity level 3 means India has the sort of stable, well-functioning and integrated regulatory system that WHO has sought to help establish since it reached a resolution in 2014. In 2019, WHO said around one-quarter of regulatory systems globally were at maturity level 3 or 4.

India plays an important role in the global vaccine supply chain, meaning the maturity of its regulatory system has an impact beyond its borders. Countries need a functional national regulatory authority to receive WHO prequalification for vaccines. India, which the health ministry said has 36 major vaccine manufacturing facilities, supplies products to prevent disease to 150 countries.

Press Release

Australia’s TGA agrees to share information with South African counterpart

Australia’s Therapeutic Goods Administration (TGA) has entered into a memorandum of understanding with its counterpart in South Africa. The agreement supports cooperation between TGA and the South African Health Products Regulatory Authority (SAHPRA).

TGA and SAHPRA already had a relationship. The new agreement is intended to build on those ties and improve capabilities in two areas: the assessment of medical products and therapeutic goods; and monitoring for continued efficacy, safety and quality once products are registered.

To achieve those goals, TGA and SAHPRA will share data that could improve regulatory functions carried out by both organizations. The focus of the data sharing is aligned with the two overarching goals of the agreement, meaning the organizations will pay particular attention to exchanges of information related to assessment and approval and postmarketing monitoring of efficacy and safety.

SAHPRA CEO Boitumelo Semete-Makokotlela said the agreement will expand the geographical reach of the pharmacovigilance programs run by both regulators. Information sharing could supplement internal expertise at the two organizations.

“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use. This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality,” Semete-Makokotlela said.

Press Release

TGA explains impact of closure of 3G mobile network on medical devices

The closure of 3G mobile networks by two Australian providers will affect older medical devices that rely exclusively on the wireless telecommunications technology, according to TGA.

Telstra and Optus, two of Australia's three main mobile networks, are switching off their third-generation systems from 28 October. The other main provider switched its 3G network off earlier this year. TGA has monitored the situation because some medical devices use 3G networks, which have been in use since the early 2000s.

Newer medical devices are equipped to use 4G or 5G networks, which will remain operational after 3G is turned off. However, TGA said “older devices that rely exclusively on 3G for data transmission or to make calls are more likely to be at risk.”

After the 3G switch off, devices that rely on 3G will be unable to send or receive data and texts or make calls, including to Australia’s emergency telephone number. Some 4G devices will be affected because they rely on 3G services to make emergency calls.

TGA has identified monitoring devices for cardiac resynchronisation therapy, pacemakers and glucose data transmitters among the products that may be affected. The regulator has asked manufacturers and suppliers of 3G-enabled medical devices to proactively inform customers and health professionals about the risks and what they need to do.

TGA Notice

WHO publishes alert about falsified propylene glycol batches in Pakistan

WHO has published a medical product alert about the presence of falsified propylene glycol in Pakistan, sounding the alarm about three batches that were found in the country in August.

The global public health body posted a similar alert in April to warn people about five batches of falsified propylene glycol in Pakistan. The batches, which falsely claimed to be DOW USP/EP PROPYLENE GLYCOL, were linked to the production of contaminated oral liquid medicines. Excipients contaminated with ethylene glycol can kill children.

WHO’s latest notice relates to three other falsified batches of DOW USP/EP PROPYLENE GLYCOL that were found in Pakistan in August. After receiving details of the batches, WHO shared the information with the Drug Regulatory Authority of Pakistan (DRAP). DRAP published alerts about the batches and oral liquid medicines that used the falsified excipients in August and September.

Like the five earlier batches, the latest excipients detected by WHO carry Dow labeling but the company has confirmed it did not manufacture or supply the products. The batch numbers listed on the labels of the containers are falsified. Officials have also identified at least one falsified Dow certificate of analysis.

WHO Alert

Japanese Pharmacopoeia seeks feedback on delayed-release aspirin tablets

The Japanese Pharmacopoeia (JP) has released a draft document about the testing of delayed-release aspirin tablets for consultation.

In the draft text, JP describes processes for identifying delayed-release aspirin tablets and assessing the purity, dissolution and other characteristics of the products. The document provides detailed instructions for how to perform each test, explaining, for example, which substances to mix with the tablets and how to perform thin-layer chromatography to complete the identification step.

The draft text covers products with the same composition as an existing document from the US Pharmacopeia. JP is accepting feedback on the draft until 30 December.

PMDA Consultation

Other news:

The New Zealand Medicines and Medical Devices Safety Authority has shared notices about the reclassification of paracetamol and naproxen. The reclassification notices describe situations in which the two molecules are classed as prescription, restricted or pharmacy-only medicines. The dose and delivery format affects how the drugs are classified in New Zealand. Paracetamol, Naproxen

Asia-Pacific Roundup: India’s CDSCO meets WHO international standards for vaccine regulations

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