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THE PHARMA REVIEW JUNE - JULY 2007 |
Why Drugs Are Banned? |
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R.K. Rishi |
Abstract: When a drug is banned in a country, the first question asked is, why it was allowed to be marketed? Was it supposed to be safe? While no drug is considered 100% safe, banning of any drug in a country is based on a risk assessment process undertaken by Governments in consultation with experts. When it comes to any drug, "safe" means that the benefits of the drug outweigh the risks for the population for which that drug is intended to be used. Safe does not mean harmless, as every drug comes with risks, and our tolerance for risk is higher for drugs that treat serious and life-threatening illnesses. It is beyond doubt that cancer drugs are highly toxic, but they are allowed to be used in humans because they also save lives. Drugs available in the market continue to be evaluated through post marketing surveillance (PMS) - a system that monitors a drug's safety on an ongoing basis. PMS system is meant to identify adverse effects of drugs that weren't observed or recognized before marketing approval and any problems that might arise because a product isn't being used as anticipated. The ultimate goal of PMS is to catch any bad news right away so that the risks associated with the drug are informed to consumers and doctors well in time!
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