EDITORIAL: Inadequate response to substandard drugs

KATHMANDU (The Kathmandu Post/ANN) - Medicines are a matter of life and death, the concerned should ensure their quality.

The Department of Drug Administration, the national regulatory body for medicines, found as many as 41 samples, from 285 essential medicines, to be of substandard quality in the last fiscal year. The medicines were sampled from state-run health facilities throughout the country. Yet, six months into the new fiscal year, neither has the report of the laboratory tests been publicised nor has there been any effort from the concerned to ban and pull these inferior drugs from the market.

The continued use of these medicines means that a large part of the population may have had their health adversely affected; many probably still continue to consume these drugs without any knowledge. This can lead to serious consequences--more so since the drugs were also being distributed through state-run facilities to the unwary. The fact that the drugs were allowed untested into the market shows how ill-prepared the health sector is to move forward with the federal system, as none of the provinces has laboratories equipped to test for quality. Moreover, the national regulator’s inaction further shows the inability of the government to deal with such quality failures.

The shoddy medicines were only found after the Nepal Health Research Council, the federal government’s premier research and policy framing body for the health sector, sent the samples to the Department of Drug Administration for tests. The initiative did not come from the regulatory body itself. And the medications that were found to be substandard were all from the government’s essential drugs list.

For example, samples of folic acid--an essential supplement that pregnant women take which helps in embryo development--were found to be inferior. This can have serious consequences on the brain and spine development of babies. Similarly, a crucial drug that helps patients with type 2 diabetes regulate blood sugar levels, metformin, was among the samples found to be of low quality. Metformin dosages are calculated to ensure that diabetes patients’ sugar levels do not reach a fatal point, and the provision of poor quality drugs can severely hamper their ability to survive.

That such crucial drugs were allowed into the market, and into government-sanctioned distributive programmes, without testing is extremely worrying. This is a direct failure on the state’s part to ensure quality healthcare for its citizens. It also points to a failure of proper implementation of the federal health system. While the task of purchasing essential drugs has been handed over to the provincial governments, they still do not yet have the capability to conduct tests to ensure quality delivery. The problem here is that transition has occurred in an ad hoc, unsystematic manner.

The process has failed to handle even the simplest of problems, such as transferring staff and defining the role of district health offices. But with the role medicines, from essential supplements to life-saving drugs, have in ensuring the health and wellbeing of generations of Nepalis, the provinces should have been provided more planning and funding support to set up regulatory agencies and laboratories before the transition to a federal system began.

Still, the issue in this particular case goes deeper than a failure of transition or capacity. As soon as the Department of Drug Administration knew about the substandard drugs, it should have, in its capacity as a regulatory body, immediately moved to recall the inferior brands. It still can make amends--the public’s health depends on the concerned springing into action.

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