Malaysia Mandates Testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in High-Risk Oral Liquid Products

On February 10, 2026, the National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health Malaysia, issued “Directive No. 8 of 2026” requiring mandatory testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in high-risk active ingredients, excipients, and finished oral liquid products. The directive was issued under Regulation 29 of the “Control of Drugs and Cosmetics Regulations 1984” following a decision by the Drug Control Authority (DCA) at its 417th meeting on February 3, 2026.

The measure strengthens Malaysia’s pharmaceutical quality oversight and introduces new testing and documentation expectations for companies supplying oral liquid products to the Malaysian market.

The directive affects a wide range of stakeholders involved in the development, manufacturing, and commercialization of these products, including:

• Pharmaceutical manufacturers
• Health supplement companies
• Natural product manufacturers
• Local and overseas product registration holders (PRHs)
• Contract manufacturers

Global Contamination Incidents Drive New Malaysian Controls

The new directive reflects growing international regulatory concern over contamination of pharmaceutical solvent excipients with toxic glycols.

According to the directive, the World Health Organization reported multiple incidents of DEG and EG contamination in pharmaceutical products worldwide. Between 2022 and 2023, these contamination events were linked to more than 300 pediatric deaths, primarily resulting from acute kidney failure.

Many of these incidents involved contaminated excipients used in oral liquid medicines, particularly pediatric formulations. In response, regulators globally have emphasized stronger supply chain oversight and testing controls. Malaysia’s directive follows this trend by focusing specifically on excipients known to present elevated contamination risk.

The directive identifies several excipients historically associated with DEG or EG contamination, including:

• Glycerin
• Propylene Glycol (PG)
• Polyethylene Glycol (PEG)
• Sorbitol and sorbitol solution
• Maltitol and maltitol solution
• Hydrogenated starch hydrolysate
• Other sugar polyols produced through catalytic hydrogenation processes

Manufacturers using these materials in oral liquid formulations are expected to implement appropriate testing controls to verify DEG and EG levels before product release.

Scope of the Directive: Products Subject to Testing

The directive applies broadly to registered oral liquid dosage forms that contain high-risk active ingredients or excipients. By covering multiple regulatory product categories, the requirement extends beyond prescription medicines.

Affected categories include:

• Poison category (Category A) medicines
• Non-poison category (Category X) medicines
• Health supplements (Category N)
• Natural products (Category T)

As a result, the directive applies to a wide range of products marketed in liquid form, including over-the-counter medicines and supplements.

Permissible Limits for DEG and EG

To ensure consistent safety standards, the directive establishes clear quantitative limits for contamination. Maximum allowable levels are:

• Diethylene Glycol (DEG): ≤ 0.1% (1000 ppm)
• Ethylene Glycol (EG): ≤ 0.1% (1000 ppm)

Products exceeding these limits are considered non-compliant and may trigger regulatory action, including investigation and potential market measures.

Acceptable DEG and EG Testing Approaches

To support implementation, NPRA outlines two acceptable regulatory approaches for demonstrating compliance with DEG and EG testing requirements.

Before selecting a testing strategy, companies must also ensure that analytical methods used are capable of reliably detecting glycol contamination at the specified limits.

Recommended Analytical Methods

The directive recommends gas chromatography (GC) as the primary analytical approach for detecting DEG and EG contamination.

Acceptable methods include:

• GC-FID (Gas Chromatography – Flame Ionization Detection)
• GC-MS (Gas Chromatography – Mass Spectrometry)

Testing may be performed either by the manufacturer’s in-house quality control laboratory or by an accredited external laboratory.

Testing of High-Risk Active Ingredients or Excipients

Under this approach, manufacturers test high-risk excipients or active ingredients for DEG and EG contamination before they are used in production. Verifying compliance at this stage helps prevent contaminated materials from entering the manufacturing process.

Testing of the Finished Product

Where testing of excipients is not performed, manufacturers must instead test the finished oral liquid product.

However, the directive emphasizes that finished product testing does not replace broader Good Manufacturing Practice (GMP) obligations. Manufacturers must still maintain appropriate quality management controls, including robust supplier qualification procedures and supplier audits.

These measures ensure that contamination risks are addressed throughout the supply chain rather than only at the final product stage.

Implementation Timeline

NPRA has introduced a phased implementation period to allow manufacturers time to adjust their quality systems and testing procedures.

PhaseDateStatusVoluntary ImplementationApril 1, 2026Transition period beginsMandatory ComplianceApril 1, 2027Full enforcement

After April 1, 2027, failure to comply with the directive may lead to regulatory review of the product’s registration status and potential enforcement measures.

For international manufacturers exporting oral liquid products to Malaysia, these requirements apply regardless of whether manufacturing occurs locally or overseas.

Documentation Requirements for Registration and Inspection

In addition to testing obligations, the directive establishes documentation requirements for both new product registrations and products already registered in Malaysia.

New Registration Applications Submitted After April 1, 2027

Applications submitted after the enforcement date must include documentation demonstrating DEG and EG testing compliance.

Product CategoryDocumentation RequiredCategories T, N, X (Abridged Evaluation)Certificate of Analysis (COA)Categories A, X, T, N (Full Evaluation)Certificate of Analysis (COA) + Proof of Analysis (POA)

Existing Registered Products

For products that are already registered, companies must be prepared to present testing evidence during routine regulatory oversight beginning April 1, 2027.

Authorities may request documentation during:

• GMP inspections
• GDP inspections
• Product Quality Monitoring Program sampling

Actions Required When DEG or EG Limits Are Exceeded

If testing identifies DEG or EG levels above the permissible limits, companies must immediately notify NPRA and initiate appropriate corrective actions.

Required responses include:

• Immediate reporting to NPRA
• Conducting a risk assessment
• Implementing corrective and preventive actions (CAPA)
• Submitting a market action proposal

Regulatory Implications for International Manufacturers

For companies supplying oral liquid medicines, supplements, or natural products to Malaysia, the directive introduces several operational and quality management considerations. Manufacturers should begin preparing their systems and documentation ahead of the April 2027 enforcement deadline.

Key compliance steps include:

• Reviewing product formulations for the presence of high-risk excipients
• Strengthening supplier qualification and oversight programs
• Implementing routine DEG and EG testing procedures
• Updating quality control processes and standard operating procedures
• Preparing documentation that may be requested during regulatory inspections

These steps are particularly relevant for overseas manufacturers exporting oral liquid products into the Malaysian market, where documentation and testing readiness may be assessed during inspections or product monitoring activities.

Malaysia Strengthens Safeguards Against Glycol Contamination

“Directive No. 8 of 2026” introduces a clear new expectation for manufacturers to actively verify the safety of high-risk excipients used in oral liquid products. By formalizing DEG and EG testing requirements, NPRA is strengthening oversight of contamination risks that have previously led to serious global safety incidents.

For companies supplying these products to Malaysia, the directive reinforces the importance of tighter control over excipient sourcing, analytical testing, and supporting quality documentation. With mandatory compliance beginning on April 1, 2027, manufacturers should ensure that appropriate testing procedures and quality systems are in place ahead of the enforcement deadline.

For many international manufacturers, aligning existing quality systems with evolving local regulatory expectations can present practical challenges — particularly when documentation, testing evidence, and supplier controls must withstand inspection by Malaysian authorities. Cisema supports manufacturers navigating these requirements through regulatory strategy, license holding, dossier management, and compliance oversight across Malaysia and other Asia Pacific markets, helping ensure products remain compliant while maintaining operational flexibility.

Further Information

Explore Cisema’s regulatory compliance services in Malaysia.

References

For full details, refer to the official NPRA publication: “Directive on the Requirement for Testing of Diethylene Glycol (DEG) and Ethylene Glycol (EG)”.