The Consumers Association of Subang and Shah Alam, Selangor would like to question whether the efficacy and safety of generic drugs being used in the country are being regulated and monitored by the Health Ministry?

Questions are also raised if any such reports are available for public scrutiny in view of protecting the rights and interests of consumers in the country in using generic drugs as opposed to the original or branded ones.

This is a pertinent call, in view of the active promotion, prescription and usage of generic drugs by the Health Ministry to formulate and implement a comprehensive National Drug Policy (NDP) in all government hospitals to achieve optimal, accessible and cost-effective use of drugs, which is one of the most expensive components in the country's health delivery system.

As such, in facilitating policies aimed at reducing operating budgets by using less costly therapeutic alternatives, where generic drugs widely replaces the original or branded drugs in hospitals, it is pertinent that the relevant authorities conduct bio-equivalence studies for all generic drugs and retain for public scrutiny, accountable data revealing the efficacy and safety of the said generic drug being used.

Cassa questions that in an effort to control costs - without arbitrarily reducing access or lowering the quality of care - have we neglected to monitor safety, appropriateness and effectiveness of drugs, tests and procedures and the way and manner care is provided by our medical care institutions and their professional personnel?

Is there regular monitoring done and the feedback of the side effects of generic drugs recorded? This will surely help the Health Ministry to identify early increased reports on side effects of the generic drug used.

This data could facilitate and assist the relevant authorities, especially the Drug Control Authority (DCA), to regulate the penetration of generic drugs - both local and imported - into Malaysian market and ensure that such drugs prescribed are safe and efficacious for public consumption.

In this context, to protect consumers, it is crucial that efforts are made to bring into the Health Ministry's orbit and regulations traditional and direct selling health products which are being marketed aggressively with their many unsubstantiated health claims.

The writer is Cassa's president and legal adviser.