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Generic medicines,is generic medicine safe as branded drugs?

Updated: Aug 3



Yes, they are safe. On behalf of the price difference between branded drugs and generics. Let me elucidate in a nut shell as to why the price difference occurs in the first place.

Innovative drug companies spend around $1 Billion for bringing new innovative drugs to the market. To develop these block buster drugs they take a minimum of 10 years. Hence given the high cost of clinical trials and R&D these branded drugs tend to be priced heavily for the firms to recover the money spent and also to earn windfall profits (Patent life is only for 20 years for these drugs).

In US and Europe, the Generic is absolutely similar to the Brand drug. Both in terms of safety and efficacy.

However, in some countries the generic is supposedly similar to the brand drug. It is so, on paper. But many at times it may not be as effective as branded.

Generic Manufacturers wait for the patents to end and capitalize on the markets by producing bio equivalent versions of the brand name drugs. Since the only cost that is incurred by them is the cost of manufacturing and supplying, generic drugs tend to be priced 80% lower than the latter. All generic drugs get approved only when their bio-equivalence is proved and not prior to that. So they function in a similar way as brand name drugs and are safe. Hope this clarifies some of your doubts.

What is Generic medicines?

Generic Medicine or Drugs are medications created the same as the brand name drug available in market. Both are exactly the same in safety, strength, dosage, quality, performance, characteristics, and usage.

Generic medicines results in the same way and same benefit as a branded one does and this standard is applicable to all the generic medicines available.

A generic drug is the non-branded medicine which is cheaper compared to the original Branded drug. It has the same active pharmaceutical ingredient (API) but it costs 30–80% less compared to the original product. When a new company files for a patent (NDA-New Drug Application) to for example USFDA, the company gets an exclusivity to sell the drug in the market and no one can copy that medicine, hence the company gets a trademark done for that product, the exclusivity remains for around say 20 years. When the exclusivity period nears an end, another company can file to FDA to get a right to manufacture a duplicate copy of that drug. The drug should be chemically and bio equivalent to the original branded drug and undergoes all the required tests mentioned in the country’s Pharmacopoeia, once the patent expires, the drug is open in the market. Generic drug manufacturer do not have to invest huge amount of money in the initial research process, clinical trials, pharmacovigilance processes which the initial company who made the branded drug did, hence their only expense is in marketing the drug, and this makes the price of the drug cheaper. Generic drugs may vary in shape, size and color compared to the branded drugs, this is because though the API is same, due to trademark of the branded drug, they cannot copy the exact details. Hence they can vary a bit on coloring agent used, the fillers, diluents or the preservation agents used. There is a conception that the branded drugs is more efficacious compared to the generic drug since the initial testing conditions and exact compositions tested suits the branded drug the more, however on paper generic drugs are similar to the branded drugs.For countries like India and China, almost 70% of the sale is of generic drugs whereas in US it is exactly the opposite. You can watch the documentary “Fire in the blood” regarding how Big Pharma Giants blocked the supply of generics and focused more on Branded drugs in African countries affected with HIV Aids, you will get a consumer perspective of Generic drugs.

These are some points which make generic drugs different from Brand name drugs:

1. Price: Generics are cheaper than brand name drugs

2. Color: Color may vary due to the presence of an inactive ingredient in the drug.

3. Taste: The taste of a generic drug may be different from Brand name drugs due to an inactive ingredient.

But the pharmaceutical properties are the same as brand name drugs.

https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers#q1


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