Asia-Pacific Roundup: India becomes IMDRF affiliate member

India’s Central Drugs Standard Control Organization (CDSCO) has joined the International Medical Device Regulators Forum (IMDRF) as an affiliate member. The Indian Ministry of Health and Family Welfare said the membership will strengthen CDSCO’s medical device regulatory system.

In recent years, the Indian government has introduced regulations for medical devices to align the country's regulatory framework with globally accepted standards and to grow the Indian medtech industry.

IMDRF, which was established in 2011, brings together regulators from countries and regions including the US, EU and Japan to accelerate the harmonization and convergence of medical device regulations. Recent projects include the creation of guiding principles for good machine learning practice in medical device development and in support of medical device health equity.

As an affiliate member, CDSCO will participate in IMDRF open sessions. The Indian organization will exchange information on technical topics with other regulators, discuss medical device regulatory strategies and trends, provide feedback on its experience and perspectives, and use IMDRF documents as the basis for its regulatory frameworks.

CDSCO’s participation will strengthen India’s medical device regulatory system, helping to “meet emerging technical challenges that are increasingly diverse” while ensuring the protection of public health and safety, according to the Indian Ministry of Health and Family Welfare. As an affiliate member, CDSCO will “continue to maintain the goal of international recognition for its medical device regulation.”

International recognition is central to the government’s plans to grow the Indian medical device industry. Supported by the affiliate membership, Indian medical device manufacturers could meet the regulatory requirements of IMDRF member countries while strengthening “Brand India” in the global market, the ministry said.

India joins Botswana, Chile, Cuba, Egypt, Israel, Paraguay, Peru, South Africa and others on the list of affiliate members. At the most recent IMDRF meeting, Asian countries including China, Japan, Singapore and South Korea shared updates on their medical device regulations.

Press Release

TGA receives report of life-threatening adverse event linked to counterfeit semaglutide

Australia’s Therapeutic Goods Administration (TGA) has published a warning about counterfeit semaglutide after a person suffered a life-threatening adverse event while using a fake version of the GLP-1 drug.

Shortages of Novo Nordisk’s Ozempic and Wegovy, respectively the diabetes and weight-loss brands for semaglutide, and Eli Lilly’s rival GLP-1 receptor agonist products have created opportunities for counterfeiters. TGA warned the public about counterfeit semaglutide in 2023 and other global regulatory agencies have issued similar alerts.

TGA sent another notice last week after receiving a report of a life-threatening adverse event in a person who used a counterfeit pen labeled as Ozempic that contained insulin. Unintended insulin use can cause dangerously low blood sugar levels. The person bought the counterfeit product outside of Australia.

Working with the Australian Border Force, TGA has detected another counterfeit pen product labeled Ozempic. The pens are now undergoing laboratory testing. TGA said the imported product, which authorities bought online from a website outside of Australia, and the pen that caused the adverse event both appear to be relabeled insulin pens. Both products differ visually from authentic Ozempic.

“The end cap is blue (not gray), the dosage barrel is in a different place, the sticker is not adhering properly to the pen and the rendering of the packaging is poor quality,” TGA said. Neither product has a genuine batch number. TGA shared images of falsified and genuine Ozempic pens and packaging.

TGA said counterfeiters “are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources.” Australians were previously able to buy compounded GLP-1 drugs but TGA prohibited sales at the start of October.

TGA Notice

PMDA imposes safety measures on sodium valproate after reviewing overseas data

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has updated the electronic package insert for sodium valproate to address a potential link to neurodevelopmental disorders in children whose fathers take the medicine.

PMDA took the action after reviewing the results of a post-authorization safety study and other evidence of the risks of the drug, which has been used as a treatment for epilepsy and other conditions in Japan since 1975. Based on the European studies, the regulator concluded the possibility of the occurrence of neurodevelopmental disorder children with paternal exposure to sodium valproate cannot be ruled out.

The data, coupled to the opinion of experts PMDA consulted, led the Japanese regulator to update the “other precautions” section of the drug’s electronic package insert. The updated insert informs healthcare professionals of reports of the link with and without a statistically significant increased risk. PMDA has asked healthcare professionals to review the new inserts.

The agency shared details of the update alongside information about the revisions of the precautions for mirogabalin besilate. PMDA updated the precautions for the neuropathic pain treatment in response to evidence of renal impairment in people treated with the medicine.

PMDA Report

DRAP moves drug import license process to Pakistan Single Window digital platform

The Drug Regulatory Authority of Pakistan (DRAP) is preparing to use an integrated digital platform to issue drug import licenses and electronic release orders.

Previously, companies used the Web Based One Customs platform to apply for the licenses and orders. DRAP is now switching to the Pakistan Single Window (PSW), an integrated digital platform that acts as a single-entry point for all import, export and transit-related regulatory requirements.

DRAP launched the first phase of its switch to PSW in February. All import-export matters related to the sea and dry ports at Karachi moved to the digital platform in August. On 8 October, DRAP will move all drugs imported via customs stations at Peshawar and Islamabad to PSW and make clearance subject to electronic release orders.

The regulator is asking importers to file single declarations through the PSW system to get the orders they will need to ship products via the two customs stations.

DRAP Notice

Other news:

Japan’s PMDA has updated some of its pharmaceutical educational videos. The revised videos cover the pharmacovigilance activities that are implemented in Japan to monitor adverse drug reactions and the risk communication tools used to share information and promote the proper use of medicines. The videos are part of a library of educational materials provided by the agency. PMDA Update

DRAP has published a rapid alert about an unregistered, potentially falsified rabies vaccine in the supply chain in Pakistan. The regulator said falsified rabies vaccines pose a significant threat to public health because their safety and efficacy cannot be established. If a falsified vaccine fails to provide adequate immunity, an individual may be vulnerable to rabies infection. DRAP Notice

China’s National Medical Products Administration (NMPA) has reported four cases of illegal and irregular online sales of medical devices. The cases, which were developed through inspections from April to July, form the seventh batch of NMPA reports on online medical device sales. NMPA Notice (Chinese)

Asia-Pacific Roundup: India becomes IMDRF affiliate member

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