Research & Reviews in Pharmacy and Pharmaceutical Sciences
Menue-ISSN:2320-1215 p-ISSN: 2322-0112
e-ISSN:2320-1215 p-ISSN: 2322-0112
Lalitha school of pharmacy, Hyderabad, India
Received date: 04-06-2016; Accepted date: 22-06-2016; Published date: 28-06-2016
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Generic Drugs, Branded Drugs, Pharmaceuticals, Medications, Abbreviated New Drug Application (ANDA), FDA.
Generic medicine contains equivalent active ingredients, within the exact same strength, as brand-name medicine. Once a drug is initial developed, the drug company that discovers and markets it receives a patent on its new drug. The patent sometimes lasts for twenty years, to allow the originating company an opportunity to recoup its analysis investment. Once the patent expires, a generic version of the drug might become on the market. Generics ar marketed underneath the drug's chemical, or generic, name and meet an equivalent FDA quality and effectiveness standards because the original [1-5].
Is generic medication as effective as brand-name drugs?
A drug is that the same as a drug in dose, safety, strength, quality, the approach it works, and the approach it's taken and therefore the approach it ought to be used. FDA needs generic medication has constant top quality, strength, purity and stability as brand-name medication. Not each drug contains a drug [6-10].
Once new medication area unit 1st created they need drug patents. Most drug patents area unit protected for twenty years. The patent, that protects the corporate that created the drug 1st, does not permit anyone else to form and sell the drug. Once the patent expires, alternative drug firms will begin commerce a generic version of the drug. But, first, they need to take a look at the drug and therefore the agency must approve it. Creating a drug prices numerous cash. Since drug manufacturers don't develop a drug from scratch, the prices to bring the drug to plug area unit less; so, generic medication area unit sometimes more cost-effective than brand-name medication. But, drug manufacturers should show that their product performs within the same approach because the drug [8].
How generic medication approved?
Drug corporations should submit abbreviated new drug application (ANDA) [5], for approval to promote a generic product. Drug corporations gained bigger access to the marketplace for pharmaceuticals, and originator corporations gained restoration of patent lifetime of their product lost throughout FDA's approval method [11-16].
New drugs, like alternative new product, square measure developed beneath patent protection. The patent protects the investment within the drug's development by giving the corporate the only right to sell the drug whereas the patent is in result. Once patents or alternative periods of exclusivity expire, makers will apply to the authority to sell generic versions. The ANDA [5], method doesn't need the drug sponsor to repeat expensive animal and clinical analysis on ingredients or indefinite quantity forms already approved for safety and effectiveness [6].
Standards for a generic drug
Health professionals and customers may be assured that agency approved generic medicine have met an equivalent rigid standards because the pioneer drug. It should contain an equivalent active ingredients because the pioneer drug(inactive ingredients could vary) be identical in strength, dose kind, and route of administration, have equivalent use indications, be bioequivalent, meet an equivalent batch necessities for identity, strength, purity, and quality, be factory-made underneath an equivalent strict standards of FDA's smart producing observe laws needed for pioneer product [16-20].
When a drug product is approved, it's met rigorous standards established by the agency with relation to identity, strength, quality, purity, and efficiency. However, some variability will and will occur throughout producing, for each brand and generic medicine. Once a drug, generic or brand, is factory-made, terribly tiny variations in purity, size, strength, and different parameters area unit allowable. Agency limits what proportion variability is suitable. Generic medicine area unit needed to possess an equivalent active ingredient, strength, dose kind, and route of administration because the brand product [21-25].
Generic medicine ought not to contain an equivalent inactive ingredients because the brand product. The drug manufacturer should prove its drug is that the same as (bioequivalent) the brand drug. For instance, once the patient takes the drug, the number of drug within the blood is measured. If the amount of the drug within the blood area unit an equivalent because the levels found once the brand product is employed, the drug can work an equivalent.
Through review of bioequivalence [9] knowledge, agency ensures that the generic product performs an equivalent as its various brand product. This customary applies to all or any generic medicine, whether or not immediate or controlled unharness. All generic producing, packaging, and testing sites should pass an equivalent quality standards as those of name medicine, and also the generic product should meet an equivalent exacting specifications as any brand product. In fact, several generic medicine area units created within the same producing plants as brand drug product [9].
Generics drugs works same as brand drugs
A study evaluated the results of 42 published clinical trials that compared diabetic generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic drugs [10].
The Food and Drug Administration (FDA) requires generic drugs to have the same quality, strength, purity and stability as their brand-name versions. Generic drugs are thoroughly tested to make sure their performance and ingredients meet the FDA’s standards for equivalency [26-30]. Generic drugs work in your body in the same way and in the same amount of time as brand-name drugs.
Both brand-name and drug facilities should meet identical standards; the bureau won’t allow medicine to be created in substandard facilities. The bureau conducts regarding three, 500 inspections a year to make sure standards are met. In fact, brand-name companies are connected to associate degree calculable five hundredth of drug production. They often build generic copies of their own or alternative brand-name medicine, and then sell them with a generic name.
The science of bioequivalence evaluations for generics has been in place in most countries for more than 20 years with an established track record of therapeutic equivalence. These evaluation methods have been so successful in establishing generic drug standards that they are largely consistent between all of the major drug regulators worldwide. Consumers and health professionals alike can be reassured that generic drugs approved under these regulatory frameworks are indeed bioequivalent, and therefore, interchangeable with brand name products [12].
Why generic drugs are cheaper?
Cheaper doesn't mean lower quality it was a misconception. Actually a generic drug is cheap compared to originals because the generic manufacture not needed to repeat the expensive clinical trials, expensive advertising, marketing, and promotion. Generic drug companies don’t have the expense of researching and developing a new chemical entity. There is usually competition among generic drug manufacturers [30-35]. Most of the generic drug manufactures switch to the same product this creates competition within the market place, typically leading to lower costs (Table 1).
| Used as | Generic name | price | Branded drug | price |
|---|---|---|---|---|
| Painkiller | Paracetamol | Rs 2.45 | Crocin | Rs 11 |
| Calpol | Rs 10.70 | |||
| Paracetamol syrup | Rs 9.00 | Crocin (syrup) | Rs 15 | |
| Febrex | Rs 20.50 | |||
| Diclofenac sodium + Paracetamol | Rs 4.4 | Diclogesic | Rs 19.40 | |
| Antibiotic | Amoxicillin | Rs 13.2 | LMX | Rs 40 |
| Remox | Rs 38.7 | |||
| Azithromycin | Rs 41.8 | Azee | Rs 107 | |
| Azithral | Rs 128.55 | |||
| Anti-TB | Ethambutol | Rs 14.8 | Myambutol | Rs 15.3 |
| Vitamins | Folic acid | Rs 2.8 | Folivite | Rs 11.8 |
| B-complex | Rs 1.8 | Becosul | Rs 11.0 | |
| Cardiovascular (Blood Pressure) drug | Atenolol | Rs 7.0 | Aten | Rs 23.8 |
Table 1: price list of generic & branded drugs
When a corporation develops a brand new drug and submits it for Food and Drug Administration approval, a 20-year patent is issued, preventing different corporations from mercantilism the drug throughout the lifetime of the patent. As a drug patent nears expiration, any drug manufacturer will apply to the Food and Drug Administration to sell its generic version. As a result of these makers didn’t have an equivalent development prices (such as years of high-priced research), they will sell the drug at a reduction. Once generics square measure allowed, the competition keeps the worth down. On average, the price of a drug is 80 to 90% not up to the brand product. In 2011 alone, the employment of FDA-approved generics saved $158 billion, a median of $3 billion weekly [36-40].
FDA monitoring
FDA will take care of the adverse reactions of the drug and regularly monitor the generic products. FDA is stepping in to take control of generic drugs and applying stringent rules for the manufacture regarding the quality of the product. FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur [15].
The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient. Reports are monitored and investigated, when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured [16].
Safety of generic drugs
There is misconception about the safety of the generic drug that it won’t work as the branded product. Generic and brand name drugs have identical active ingredients, and generic drugs must meet standards for bioequivalence.so people can take the generic drug without any fear [41-45].
FDA doesn't permit a 45% distinction within the effectiveness of the drug product. When it involves worth, there's a giant distinction between generic and brand medicine. U.S. trademark laws do not permit generic medication to appear precisely the same as another drug already on the market. For that reason, the colour and form of a generic pill could also be completely different than the brand-name. Typically it'll have a distinct coating or flavor. Variations in style or look don't have an effect on the drug's safety or effectiveness [18].
You can use generics with confidence. Although they may look different from their brand-name versions, generics are safe and effective. As always, any medication changes must be discussed with your physician and pharmacist [19]
The savings related to policies that encourage the employment of cheap generic prescribed drugs create them a plain selection within the struggle to contain health care prices. However, policymakers and researchers ought to address the queries close the therapeutic equivalence of generic medication; develop ways of encouraging generic utilization among all consumers; and make a statutory pathway for the approval of generic biological drugs. Additionally, given the inherent complexness of the health care system, it's probably variety of generic utilization policies ought to be combined in an exceedingly a lot of comprehensive approach before drug utilization are often maximized [46-50].
It is the government's task to supply health professionals with correct info concerning generic medicines. Completely different initiatives, like visits from government representatives, audit and feedback on prescribing knowledge or pharmacotherapeutic discussion teams (with physicians solely or physicians and pharmacists) have, therefore, been enforced in some European countries. These activities ought to inform physicians concerning the benefits of generic medicines and purpose them at the cost–consequences of their prescribing behavior. Health care professionals' information and perception of generic medicines were absolutely influenced by these activities.
This demonstrates the necessity of continuous medical education for each physicians and pharmacists [51]. People ought to remember of each the brand-name and generic versions of a medicine. So as to assist them perceive that the drugs share a similar active ingredients. As a result of generic medicine usually take issue in look or packaging from their brand-name equivalents, suppliers ought to additionally clear up any confusion patients could have by reminding them that these visual details don't have any impact on a drug’s safety or effectiveness [18,21].