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Regulating medicines

Published: February 3, 2012

In such cases, government should step in and help out because the idea is not to kill industry but to make it work.

The discovery that the heart medication Isotab — manufactured by a Karachi-based company — was contaminated and had been responsible for dozens of deaths has caused understandable alarm amongst the public. Yet, we feel that had this crisis been managed better, much of what may soon become the economic fallout could have been avoided. The pharmaceutical industry in Pakistan is small, but growing at a healthy pace and even beginning to export some of its products now. The last thing they needed was a panic like this one. There had been rumours of cancelled export orders and countries reconsidering allowing Pakistani pharmaceutical exports into their markets. Pakistan’s reputation as a producer of reliable drugs is at stake. One bad batch of medicines does not mean that the whole industry is not worth saving and protecting. If we allow the present discourse to devolve into finger-pointing, we could potentially ruin what could be a strong export revenue generator for Pakistan. Each of the protagonists could have acted better. The pharmaceutical company which is now under scrutiny should have acted faster in determining what the problem was and should have recalled the entire stock of the drug as a gesture of proactive goodwill. In the pharmaceutical business, credibility is everything and worth paying for to protect. Meanwhile, the federal and Punjab governments should have acted more responsibly, instead of engaging in a blame game. They should have acted in concert to help prevent the further dissemination of the contaminated drugs.

The fact is that pharmaceutical manufacturing is a dangerous business. Accidents can and do happen and mistakes can and will be made. The most effective response is to be able to quickly determine exactly what went wrong in the manufacturing process or supply chain and fix it. This process requires the collaboration of both the manufacturer and the regulators. The US and the EU are generally good examples of this. There, incidents such as these, but on a smaller scale, have happened, but the industry wasn’t shut down. Rather, the government stepped in and helped out because the idea is not to kill the industry but to make it work and become a provider of safe and affordable medicines.

Published in The Express Tribune, February 4th, 2012.

Reader Comments (2)

  • Concerned
    Feb 4, 2012 - 12:48AM

    Thank you! Maybe if people read this article they will realize that they have a role to play as Pakistanis – which is of responsible, problem-solving citizens. Wish we have more articles like this one. One asking for solutions rather than talking about the problem over and over again. Let’s pray that the pharma industry doesn’t get impacted in as bad a way as it seems and that it overcomes this crisis. Long live Pakistan!

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  • It's (still) the economy, stupid
    Feb 4, 2012 - 4:55AM

    “The fact is that pharmaceutical manufacturing is a dangerous business. Accidents can and do happen and mistakes can and will be made.” This is nothing but a justification for negligence. UndercGMP all batches of drug before release has to be analyzed to ensure that it contains the correct active pharmaceutical ingredient, inactive carrier and any impurities including nature and amount of impurities. If impurities are found a toxicologist has to justify that the impurity is safe to the human beings. Once a Toxicologist signs the paper than the drug is released from the warehouse. None of this happened and probably never happened.
    Owner never reported the stolen drugs and did not took proactive action shows it lacks respect for the patients. I think it is the company culture and it needs to be challenged to ensure that the safety is number one from top to bottom. It is about time company implements cGMP ( a norm for the industry) and hire right peole and buy good analytical equipent. As the saying goes If you can not handle the heat than get out of the kitchen.

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