Asia-Pacific Roundup: India starts mandatory tests of exported cough syrups after child deaths

India will require manufacturers of cough syrups to acquire a Certificate of Analysis (CoA) from a designated laboratory before they can export their products, starting 1 June. The new requirement follows the deaths of children who consumed cough syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG).

The World Health Organization (WHO) linked some deaths to products manufactured in India. Until now, India has had a free export policy on cough syrups, meaning companies can ship products overseas without submitting paperwork to show they meet requirements that restrict the content of EG and DEG.

Both forms of glycol are highly toxic byproducts of the production of propylene glycol. Manufacturers of pharmaceutical-grade propylene glycol purify their products to remove toxins, resulting in excipients that contain safe levels of EG and DEG. The use of cheaper, industrial-grade propylene glycol, due to either errors or cost-saving substitutions, can result in medicines that cause kidney failure and death.

Beginning 1 June, manufacturers will need to send samples for testing at either the Indian Pharmacopoeia Commission; one of six Central Drugs Laboratories, Central Drugs Testing Laboratories and Regional Drugs Testing Laboratories; or any State Drugs Testing Laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories.

The new policy represents a shift in India’s approach to the problem and a rare sign that the deaths have impacted how it polices the industry. India's health ministry has previously denied that cough syrups made in the country are linked to deaths in Gambia and told WHO that its allegations “adversely impacted the image” of the local pharma industry.

Shortly after the Indian government published the new trade policy, the Central Drugs Standard Control Organisation told laboratories to give “top priority” to cough syrup samples and “issue the test report at the earliest,” Reuters reports. The Drugs Controller General of India has written to state drug controllers to ask them to tell state-owned laboratories to prioritize processing cough syrup samples.

Gazette Notification, Reuters

Fake semaglutide sparks TGA warning

The Therapeutic Goods Administration (TGA) has issued a warning after finding fake semaglutide being imported into Australia. TGA found that two drug products labeled as semaglutide, used in Ozempic and Wegovy, did not contain the active ingredient.

Demand for semaglutide has increased in response to evidence that the medicine can support weight loss. Wegovy is approved for use in managing obesity, while Ozempic is approved to manage blood glucose levels in people with type 2 diabetes but is used off-label for weight loss.

In Australia, some consumers have sourced products purporting to contain semaglutide from unverified online sellers. TGA tested two products labeled as Global Health Pharmaceuticals and Therapeutics 5 mg semaglutide vials and Peptides Lab 10 mg semaglutide vials. Neither product contained semaglutide per the label.

“These results serve as a warning to consumers to avoid buying semaglutide products from unverified online sellers, as they may not contain the active ingredient,” the agency wrote. “Counterfeit products may also contain other undeclared and hazardous ingredients that could cause serious risk to the health and safety of consumers. They also may not meet manufacturing quality and safety standards and have unknown contaminants.”

Ozempic remains in short supply in Australia. There are no generic versions of the drug. People with a valid prescription can import up to three months’ supply of the medicine for personal use.

Since it is illegal to advertise prescription medicines to the Australian public, any website promoting Ozempic or semaglutide “is illegal and likely represents a counterfeit product or a scam,” TGA wrote. Any overseas websites advertised as supporting the Personal Importation Scheme “should be approached with extreme caution” and “advertisers are prohibited from using a government logo or implying that any government body endorses a therapeutic good.”

TGA Notice

WHO works with Korea and Japan to strengthen regulatory, biomanufacturing capacity

The World Health Organization (WHO) has started working with officials in Korea and Japan to build regulatory capacity in Asia and train people in the production of biologics such as vaccines, insulin and monoclonal antibodies.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met with WHO officials earlier this year and shared details of their discussions last week. The partners plan to leverage PMDA’s Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs to provide training and seminars and to plan capacity building in the Association of Southeast Asian Nations countries.

WHO referenced its intensification of “regulatory system strengthening to ensure the quality and safety of health products” in a separate notice about its collaboration with the Republic of Korea. The two parties have signed a memorandum of understanding (MOU) to establish a global training hub.

The MOU covers the creation of a global training center that will help low- and middle-income countries produce biologics, such as vaccines, insulin, monoclonal antibodies and cancer medicines. WHO sees the center as addressing a skills gap that could stymie its work to equip countries to make their biologics and ensure equitable access to an important class of medicines.

“Korea is offering a large range of national training facilities and programs covering the full spectrum of biological manufacturing and is expanding its operations to accommodate more trainees from other countries with the construction of a Global Bio Education Campus to be launched in 2025,” WHO wrote.

PMDA Notice, WHO Statement

Philippine FDA seeks feedback on import and export guidelines for drug products, APIs

The Philippine Food and Drug Administration (FDA) has released draft guidelines on importing and exporting finished drug products and raw materials.

FDA is creating guidelines to clarify the procedures for issuing Clearance for Customs Release (CFCR) and conducting inspections of entry/exit ports authorized by the Bureau of Customs. The guidelines will apply to all FDA-licensed drug establishments involved in manufacturing, importing and exporting finished drug products and raw materials. Investigational products are excluded from the guidelines.

The draft guidelines describe the documents companies must upload to the FDA eServices Portal System to import or export finished drug products and raw materials. Once companies have an approved CFCR, they must submit more information, such as the products’ arrival date or materials, as part of their post-approval commitments.

FDA is accepting feedback until 23 June.

Draft Guidelines

Asia-Pacific Roundup: India starts mandatory tests of exported cough syrups after child deaths

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