What is Allegation and why is it important in Pharmaceutical Industry? Every Pharmaceutical Engineer or scientist in the field of Pharmaceutical Claims must be aware of this question, as this plays a vital role in the claim approval procedure. There are times when the company claims that their product is the best in the market and it can cure all the common diseases like arthritis, cancer and so on. But then a scientist from any other company can challenge those claims and say that his product is much better than the claimed one. This can be seen in many Pharmaceutical Industry related court cases.
So, how does this impact the whole process of Pharmaceutical Claims and what is it all about? Basically, the company scientists work very hard to prove their point. They take years to complete the research work and then present their case to the regulatory authorities of the country. After having the information checked by the FDA (Food & Drug Administration) they submit the final documents. They should provide hard data, accurate graphs and pictures along with the references cited by other scientists who have worked on the subject. This helps the FDA in verifying the data and then approving the claim.
But then there are times when the company reverses the processing of the drug or suggests another alternative for curing the disease. In such a situation the regulatory authority takes over the responsibility of the drug and declares it to be safe. Thus, when the manufacturer disputes the safety of the drug and asks for redetermination of the drug, the entire process gets canceled and the product comes under the scanner. This is the reason why the company scientist spends years in the laboratory but get frustrated in the process.
The second major reason as to why questions like what is the allegation and why is it important in the pharmaceutical industry is because of the demand of the product. Every year millions of new drugs are introduced into the market, which is enough to challenge the scientists to produce accurate drug related data. If all the data is properly scrutinized and analyzed then the company can claim its product to be effective. However, if the data is found not to be correct or if the analysis is found to be flawed then the company has to restart the testing process from the scratch.
So the question still stands that what is allegation and why is it important in the pharmaceutical industry. It is because of the excessive amount of data required to evaluate and verify the efficacy of the drugs. Since the company has to make a return on its investment in manufacturing and launching the product, they have to make claims and stand by them. This means even if a drug has been tested many times it cannot be claimed to be effective unless the company is successful in providing a larger number of data points. It is for this reason that the importance of Allegation in Pharmaceutical Industry cannot be neglected.
What is Allegation in Pharmaceutical Industry? First of all an effective drug must not only be able to achieve desired results, but it must also be safe. Any company manufacturing drugs can come up with stories about the safety of their products. However, there are certain factors that may not support such claims. For example an accidental death cannot be considered as ‘safe’ when the cause of death is due to the medication taken by the patient.
So, what is Allegation in Pharmaceutical Industry? At a larger scale companies make claims about their products and then do nothing to back them up. There are certain reasons why the company may not release data supporting their claims. If the data is available, it can be used by other research institutions but it will not be manipulated or used for any commercial purpose.
Hence, we can conclude that what is allegation and why is it important in the pharmaceutical industry? It is because of the way companies justify their claims or lack of them. Without such justification, it is irrelevant about what is allegation and why is it important in the pharmaceutical industry.