WITH DIFFERENT brands of generic drugs steadily increasing in number here in the Philippines, consumers can’t help but wonder if these low-priced drugs are as effective and as safe as the original (innovator) drugs they copied.

The fact that a number of doctors would rather not prescribe them (especially if their patient could afford buying the innovator drug brand) attest to the fact that doubt still plagues generic drugs.

With such misgivings still hounding generic drug brands, it’s interesting to note that another group – aside from the Bureau of Food and Drugs – is doing its share in making sure your chosen generic drug brand will measure up.

“A particular brand of generic drug should qualify in the market not only on the basis of its low cost but also of its quality (potency) and safety,” stressed Dr. William Torres, president of the University of Santo Tomas Center for Drug Research, Evaluation and Studies (UST-CeDres).

The UST-CeDres was initiated five years ago to assist the government in qualifying pharmaceutical products in the country in terms of their safety and efficacy performance.

Primary mission

Its primary mission is to ensure safe and effective drugs by conducting state-of-the-art drug research, specifically bioequivalence/bioavailability studies, clinical research and monograph testing.

The UST-CeDres could compare a particular generic drug brand’s “bioequvalence” meaning its manufacturer must prove that it has the same strength as the innovator drug, and affects people the same way within the same time frame, as well as its bioavailability, meaning, the degree to which or rate at which the generic drug (compared to the innovator) is absorbed or becomes available at the site where it is needed.

For example, the UST-CeDres recently conducted bioequivalence/bioavailability study of generic hypertension drug (amlodipine besilate) manufactured by Prime Drug, under brand name Amlobes 5 mg tablet, comparing it with the innovator drug, Norvasc 5 mg tablet.

The results reveal that Amlobes is bioequivalent as well as bioavailable to the reference or innovator drug Norvasc.

“The idea for generic a drug brand is that it should be interchangeable with the innovator drug. For example, when you decide to shift from an innovator drug brand to its generic counterpart, it should have the same effect, nothing more, nothing less,” pointed out Dr. Benjamin Co, executive director of UST-CeDRES.

Co added that it was the burden of manufacturers of generic drug brands to prove that they are bioequivalent/bioavailable.

While the UST CeDres is capable of conducting at least 52 bioavailability/bioequivalence studies every year, he admitted that only 80 percent of the pharmaceutical companies take advantage of their services.

“It is a moral obligation, an ethical requirement for the companies to have their products undergo bioequivalence/bioavailability testing. These companies should be admired as their responsibility to consumers comes first,” Co said.

Center of excellence

Recognized as the center of excellence for bioequivalence and bioavailability by the United States Pharmacopeia, UST-CeDres is run by an institutional review board/ethics committee comprised of distinguished professionals.

“This is to ensure that every study made here adheres to the requirements of the International Conference on Harmonization), United States Food and Drug Administration and the European Medicines Agency on both good laboratory practice and good clinical practice,” Co explained.

As one of the top and most credible drug research centers in the country, UST-CeDres boasts of highly trained staff and fully equipped facilities to serve the needs of the academe, pharmaceutical industry as well as government and non-government agencies for drug research.

“More than our task of doing clinical and analytical services, UST-CeDres takes on a deeper role of educating the public about the importance of knowing if drugs are therapeutically equivalent. What we want to communicate to the consumers is that generic drugs may be affordable for more people but they should be warned that not all generic version drugs conform to the standards of quality, safety and efficacy,” Torres reminded.

Co added that there was still a lot of work to do in terms of expanding the guidelines and educating the people on safe and quality drugs available in the market.

As part of its advocacy, Co said the UST-CeDres also invested on holding seminars and giving lectures to doctors who were often faced with the problem of prescribing a quality drug brand as their patients insist on getting just the cheapest.