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Published on July 12, 2007

The Food and Drug Administration (FDA) is compiling a central database of medicines that will allow members of the public to compare drug quality before purchasing.

The database should be complete and available on the Internet later this year, an academic said yesterday.

Dr Wongwiwat Tassaneeya-kul, of Khon Kaen University's Faculty of Pharmaceutical Sciences and secretary to the universal health scheme's drug quality monitoring system development committee, yesterday revealed initial results in preparation for the database.

The committee's random testing over the past year tried to cover all sources of generic drugs that the scheme's hospitals bought from. It found that seven of the 137 samples of 11 medicine types collected from 39 hospitals were substandard. The FDA promptly pulled these problematic drugs from hospitals and retail markets.

The drug samples - mostly prescription drugs given via injection - included antibiotics with a short validity period and most side-effects; highly competitive drugs in a market with wide price gaps; and strong drugs that could be fatal if given in the wrong dosage, according to Wongwiwat.

With the scheme's limited budget, quality checking was essential in Thailand's competitive drug market, he said. Past practice had caused a heavy workload for the Medical Science Department, as drugs were sent to its labs from many hospitals. This led to the idea of establishing an open drug-quality database, he said.

"Since the revelation of drug-quality results to the public may affect drug manufacturers and possibly bring lawsuits, the committee wants to set up a new information system for consumers. This will possibly be done through a positive approach - say, a list of drugs that had passed the test rather than those failing it," he said.

FDA pharmacist Sukanya Jiarapong said the FDA had a checking process starting from the drug's registration to random checking after the drug was released on the market. She admitted that the mass production of drugs could cause quality problems but only a small amount were affected.

She cited a random check last year of 159 drug samples which found that none of the drugs had been produced in substandard factories. How-ever, some of the drugs had become substandard as a result of transportation and storage conditions that affected their quality and efficiency.

There are over 20,000 drugs on the Thai market, with dozens more awaiting registration each year.

Duangkamon    Sajirawattanakul

The Nation