The ministry said it viewed seriously the “baseless and irresponsible” statements made by certain parties, in reference to an association’s recent criticism of its directive for the National Heart Institute (IJN) to switch government patients from using innovator drugs to generic versions.

It stressed that all medicines, including generics, must comply with the standards set by the Drug Control Authority (DCA) for their registration, which include bioequivalence studies.

“(Bioequivalence studies) are run to prove generic medicines have the same quantities of active ingredients, rates of absorption and drug blood levels as equivalent doses of innovator drugs in the same period of time.

“This (regulatory) mechanism is important to ensure generic drugs have the same therapeutic effect as innovator drugs and proves that generics approved by the DCA have equivalent levels of safety and effectiveness,” it said.

The ministry’s warning follows a recent report by CodeBlue quoting Pharmaceutical Association of Malaysia executive director Chan Li Jin as saying that merely changing medicines would not solve cost management for IJN.

Chan said it might even backfire if the patient’s condition deteriorates and requires more treatment, increasing the cost and burden.

However, the Malaysian Organisation of Pharmaceutical Industries disputed her claim as “baseless, non-factual and misleading”, saying it failed to consider the long-term economic benefits generic and biosimilar medicines bring.

Meanwhile, the ministry also said all approved drugs are subject to monitoring activities in the market, based also on product quality complaints and adverse effect reports.

“The National Pharmaceutical Regulatory Agency also conducts scheduled inspections and assessments to ensure drug manufacturers comply with good manufacturing practices and the set standards.

“Regulatory actions such as the recall of products from the market and cancellation of registration will be taken if they fail to meet the standards,” it said.

The ministry said it also prioritises the use of medicines that give the best results at appropriate prices, and stresses that generics can be both cost-effective and of high quality.

“The health ministry guarantees that the use of generic drugs is safe and effective. They can bring the best results, based on detailed assessments by certified medical practitioners of patients’ clinical needs.

“The ministry will never compromise on quality, safety and patient health merely to reduce medical costs,” it said.