There is an urgent need for a reform of the pharmaceutical industry in the developing world as counterfeit and substandard quality medicines are making their way onto the market and damaging the health of already vulnerable people. The health care system is already behind the developed world in countries including India and some African nations, and there has been little progress made in setting a standard for prescription medicines. In developed countries, GMP consulting is used to ensure that all drugs comply with good manufacturing practices and the relevant regulations, but there is no such system in under-developed countries.

There are several factors behind the failure to achieve a streamlined and regulated pharmaceutical industry in India and some African countries. A few are listed below;

? Corruption in government and business

? Lack of funds to establish a regulatory authority

? A black market of counterfeit medicines

? Lack of direction from the existing authorities

? No set GMP consulting or training system

These draw-backs make it difficult but not impossible to establish a safer pharmaceutical industry. One of the main problems is that whilst there are manufacturers ready and willing to produce safer medicines, they have no knowledge of good manufacturing practices. If GMP consulting firms worked with the manufacturers to establish complying procedures and processes this would make it a lot easier for the pharmaceutical industry to become safer. Then the authorities and regulators can begin their work. The problem at the moment is that a lot is being done to tackle counterfeit medicines and so substandard drugs are being allowed to enter the market. Until this stops and the focus shifts to quality and safety, medicines will pose a health threat to those who take them.

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