Global Health Guide

Global Health Guide

Guidelines for Manufacturing the Generic Drugs

Generic drugs are the perfect carbon copy of the branded drugs. Generic drugs works perfectly in the similar manner like the branded drugs and shows exactly the same effects. Generic drugs are perfect combination of the quality medication and low price. The main reason behind the low prices of the generic drugs is that they are manufactured in the developing countries which have the currency value very low in comparison to the dollars. Additionally generic drugs don’t have to spend any money on research, advertisement, and clinical trials of the drugs as they use the same active ingredient used by the branded drug. But, everyone today still is confused whether to buy the generic drugs. So, here is the detailed explanation for the guidelines that must be followed by the generic drugs manufacturer—

1. Generic drug are allowed to be manufactured only of those drugs whose patent is being expired. It means that suppose a company manufacturers some drugs and it patents it, then generic drugs of that same drugs could not be manufactured. But, it depends on that what company is patenting because if company patents the only the formulation then other company can use the active constituent and manufacture the drug with different name and if company manufacturers active constituent then the other company can use the formulation and manufacture the generic drugs.

2. The important guideline for the manufacturing of the generic drugs is that the manufacturer must use the same active constituent used by the branded drugs for preparing the generic drug of the same drug. Also, the concentration of the active constituent in the generic drug should be same as used in the branded drug. If the generic drugs fails to qualify this point then it doesn’t gets the approval from the Food and Drug Administration for sale in the market.

3. Another important point is that the generic drugs should show the same effect like the branded drug and in the same duration, if the generic drug fails to do so then it is not at all approved to be sold in the market.

4. The standard dosage of the generic drugs should be same as the dose of the branded drug. If suppose there 50 mg of Ampicillin in branded drug then there should be same amount of the Ampicillin in the generic drugs. Please note that this point is of great importance and first to be checked by the verifying committee.

5. The effect of the drug when it enters the human body is also checked and it is bit obligatory for the generic drugs that it also works in a similar pattern and gets washed out of the body once the effect is done. If there is the difference in the working of the drug then it is not approved.

6. According to the FDA approval norms and conditions, generic drug should not be same in the shape and color of the branded drugs. Otherwise it may difficult to identify which is branded and which is generic for the customer.

7. The side effects of the generic drugs should not be more than that of the branded drug. The side effect of the generic drugs could be same or less than the branded drug, only on these conditions the generic drugs is approved.

8. Once generic drug approvals all the quality standards then the officials from the FDA visits the manufacturing unit of the generic drugs to check the manufacturing standards. If the manufacturing standards are perfect and they follow all the safety measures perfectly then the generic drugs gets the final approval.

The above mentioned guidelines are too be followed by the manufacturer strictly then only the generic drugs gets the approval.

Me Ethen H,an associated editor to the website www.trustpharma.com. It is guaranteed and committed to provide customers a wide range of Men's health products such as Apcalis,Caverta,Generic Levitra, generic viagra etc. We at trustpharma.com work hard to bring you the highest quality generic drugs at the most competitive prices.


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