Health

Generic medicines in Malaysia are subject to rigorous regulatory oversight

Misconceptions among patients and medical professionals continue to hinder wider acceptance

Updated 7 months ago · Published on 25 Jan 2026 8:45AM

Generic medicines in Malaysia are subject to rigorous regulatory oversight
Ministry’s push to prioritise generic drugs has delivered substantial public savings and strengthened value-for-money healthcare spending - January 25, 2026

THE government has saved more than RM900 million over the past two years by expanding the use of generic medicines, reflecting a broader strategy to improve value-for-money spending, particularly in high-cost sectors such as healthcare.

Generic medicines contain the same active ingredients as brand-name drugs and function in the same way in the body, despite differences in appearance, packaging or branding.

Under Malaysia’s National Generic Medicines Framework, a generic medicine is considered interchangeable with the original product once patent protection has expired, allowing other manufacturers to produce and market the drug at significantly lower prices.

These medicines are sold using approved non-proprietary names and are manufactured without a licence from the original patent holder.

Their lower cost is largely attributed to the absence of expenses associated with initial research, development and large-scale marketing.

New Straits times reported today that the Health Ministry has long promoted the use of generic medicines within the public healthcare system.

As early as 1986, a ministry circular required medicines dispensed at public healthcare facilities to be labelled by their generic names, a policy that has since been implemented nationwide.

Despite their lower price, generic medicines in Malaysia are subject to rigorous regulatory oversight. Manufacturers must comply with the Control of Drugs and Cosmetics Regulations, including mandatory bioequivalence studies, to demonstrate that generic products meet the same standards of safety, quality and effectiveness as their brand-name counterparts.

However, public understanding of generic medicines remains inconsistent.

A 2014 study conducted by the Pharmacy Department of Hospital Teluk Intan in collaboration with Universiti Sains Malaysia’s School of Pharmaceutical Sciences, led by Dr Zhi Yen Wong, found that just over half of Malaysian patients believed generic medicines were as effective as branded drugs, while only 49 per cent were familiar with the term “generic medicine”.

The study also revealed that nearly one-third of respondents believed generic medicines were cheaper because they were less effective, highlighting persistent misconceptions surrounding quality and efficacy.

Scepticism is not confined to patients alone. A 2015 nationwide survey of private medical practitioners conducted by Universiti Sains Malaysia and led by Dr Rohit Kumar found that many doctors held negative perceptions of the safety, quality and effectiveness of generic medicines.

Health policymakers say addressing these perceptions is critical to sustaining long-term savings and ensuring equitable access to essential medicines, particularly as healthcare costs continue to rise and demand for treatment increases nationwide. - January 25, 2026

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