The high price of low quality

Published: April 8, 2014

The writer is associate professor in the departments of Biomedical Engineering and Medicine at Boston University

An old problem resurfaces again. It was hardly unexpected. Fortunately, this time it was without the loss of precious lives. A large batch of spurious medicines were seized in Lahore last week. This was one of the many reports associated with poor quality drugs in Pakistan in the last few weeks. Other similar reports have indicated the presence of expired drugs in a Karachi hospital, another seizure of drugs in Lahore last month and the busting of a ring involved in illegal drug manufacture and packaging in Karachi. Countless other incidents will go unreported and those affected will accept it as their fate. The recent seizures may be a small reason to rejoice, but there is little comfort in the fact that the prevalence of poor quality drugs continues to be a major threat to our fragile health system.

Just over two years ago, we had one of the biggest public health crises in the country. The Pakistan Institute of Cardiology drug scandal was an outcome of poor quality, poor regulation, poor oversight and poor investigation. In the next few months, some other stories about a cough syrup, Tyno, emerged, which were initially brushed under the carpet by the government staff as the responsibility of careless consumers! Hopefully those days of moral bankruptcy are behind us.

The first sign of a positive development is a discussion of the topic in parliament by Minister of State for National Health Services, Regulations and Coordination Saira Afzal Tarar, for which she deserves credit and appreciation. While underscoring the gravity of the situation, she highlighted the fact that the Drug Regulatory Authority of Pakistan (DRAP) still does not have a CEO. She argued that many of the problems of counterfeit drugs would go away if DRAP had a CEO. I doubt if that would completely solve all of the problems we see with bad drugs. Having a CEO (which is the government’s responsibility) and harsher punishments for the perpetrators of these crimes will contribute positively, but at the end of the day, the problem has to be resolved by developing and implementing a stronger policy of oversight and quality control at all points in the supply chain. There are a number of key things that have to be done in order for the problem to be effectively and comprehensively addressed.

Firstly, we have to recognise that this is not a provincial problem and neither should it be dealt with as a local issue. The smokescreen of the Eighteenth Amendment is hardly an excuse. Ensuring quality of medicines is a national priority and a national security problem, which makes everyone vulnerable, irrespective of their province.

Secondly, we have to understand that the problem of poor quality medicines is about registered companies not adhering to good manufacturing practices (due to complacency and incompetence) and lack of quality control in storage and transportation that can make good quality drugs ineffective or dangerous. The problem is much bigger than just counterfeits. As a result, the solutions we adopt nationally have to be able to address the problem in its entirety. Checking the boxes, or having Radio Frequency Identification tags or a scratch code to verify authenticity is not enough to catch degraded, poorly manufactured and inappropriately stored drugs. We need to have solutions and technologies that test drug concentration, potency and its reactivity.

Thirdly and perhaps, most importantly, the government needs to empower consumers at all points in the supply chain. This should happen through oversight of regular testing, transparency in investigations and publication of reports. We also need to ensure that distributors and pharmacists can test random batches before they accept large shipments without incurring any financial penalty.

Politicians often argue why the public should put their trust in them. Creating and sustaining solutions that guarantee public safety through safer medicines is one way to earn it.

Published in The Express Tribune, April 8th, 2014.

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