Impotant Generic Drugs Making Guidelines
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—
- 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.
- 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.
- 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.
- 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.
- 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.
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Comment by Dwayne — October 20, 2009 @ 8:18 pm