Generics undergo stringent evaluation

Tue, 02/10/2012


The Star Online

Tuesday October 2, 2012

Generics undergo stringent evaluation

WE refer to “Generic drug post strong growth” (The Star, Sept 8).

With regard to the issue of a handful of local pharmaceutical companies that produce low quality generic medicines, let us assure you that all medicines for use in Malaysia undergo stringent evaluation to ensure quality, efficacy and safety prior to approval by the Drug Control Authority.

There is also a requirement for all generics to undergo bioequivalence (BE) studies to prove that they are as effective as the original innovator product.
Facilities which manufacture medicines as well as the laboratories where the BE studies are conducted are subjected to inspections by accredited auditors from the National Pharmaceutical Control Bureau (NPCB).
Marketed products are also regularly sampled and tested to ensure compliance with regulatory requirements.

With regard to expenditure on medicines, the statistics should be analysed in totality, taking into account volume as well as cost.

When the patent expires and a generic version of a medicine becomes available, usage will normally increase as the reduced cost allows doctors to prescribe more freely for patients who will benefit from these drugs.

Thus, total expenditure will not necessarily go down due to increased volume of use.

Based on the price survey conducted by the Health Ministry (MOH), the price of Stilnox which is the innovator product containing zolpidem 10mg is between RM3.50 and RM3.70 per tablet as mentioned. The prices for generic zolpidem (Somidem, Zopim and Anpro-Zolpidem) may range between RM0.44 and RM2.80 per tablet.

We will investigate to ascertain why the price tagged for generic zolpidem has not been changed, as the price on the envelope should be based on the purchase price of the actual brand being used.

Government procurement procedures for medicines are in accordance with the policies and directives from the Treasury and other relevant agencies, to secure best value for money for the Government without compromising on quality, efficacy and safety.

Health Ministry procurement involves not only the price of the medicine but is inclusive of delivery charges to all facilities throughout the country. This may result in a slightly higher price compared to a clinic where delivery costs may be negligible especially in the Klang Valley.

We acknowledge the complaint that Anpro-Zolpidem is not as efficacious as other brands of zolpidem, and this issue has been forwarded to the drug regulatory agency for immediate investigation.
However, please be aware of the fact that patients may experience or show variation in their response towards medicines for reasons which may not necessarily be attributable to the quality of the product.

We are committed towards ensuring the quality, efficacy and safety of medicines used in the country and we value comments which will help us to further improve the standard of pharmaceutical care provided to the public.

Senior Director of Pharmaceutical Services
Ministry of Health Malaysia