Generic Drugs: The Cost-Effective Healthcare Option
According to research, regions like US, Europe, Japan, and Africa provide great opportunities to Indian drug manufacturers who already hold a 10.5% share in the US generic market in 2010. Countries in the European and African regions are primary consumers of the Indian generic medicines. Furthermore, an increasing number of FDA, WHO approved plants and agreements between big pharma and domestic generic companies suggest that India may soon become a generic medicine hub on the world map.
The Indian generic drug market has made some key developments that offer a huge scope of opportunities for the generic medicine suppliers of India. Patent expiries have resulted as an important growth booster. Moreover, government support also plays a pivotal role in the development of India in global pharma.
Generic drugs are becoming a widely chosen alternative to brand-name drugs. Although there are many people who still do not have enough knowledge about generic drugs and its benefits.
What are generic drugs?
A generic medicine is a drug created to be the same as an existing approved brand-name drug in dosage, form, safety, strength, route of administration, quality and performance characteristics. In simple terms when the patent of a brand-name medication expires, a generic version of that drug can be produced and sold.
Every drug starts out as a brand-name product. Pharmaceutical companies invest a whole lot of time and money on research, development, and manufacturing of the medicine. After getting the approval from the Food And Drug Administration(FDA), the drug receives its patent. The patent gives the pharmaceutical company that created the drug the right to exclusively sell it for a certain time period. Brand- drugs are costlier because the company has to cover-up the research, development and promotional costs.
As the drug’s patent nears its expiry date, other pharmaceutical companies apply to the FDA for permission to make and sell the generic version. The FDA confirms that a generic drug is identical or bioequivalent to a brand name drug.
The FDA has set parameters that the generic medicines need to meet, to receive approval from them. All the generic drugs are reviewed thoroughly and only then approved by the Food And Drug Administration before they can be prescribed or sold over-the-counter. The Indian drug market has seen a considerable rise in the demand for generic drugs as a result of which the generic medicine suppliers of India are being hugely benefited. The dramatic growth in the use of generic drugs has generated substantial savings for Indian consumers.
What are the benefits of using generic drugs?
Now that you have been informed about generic drugs, it is time to go a step further and discover the benefits of these medicines.
The main reason why so many people prefer generic drugs over brand-name drugs is that they are far more affordable. It can help you save money. Generic medicines usually cost 50-85% less than the brand name drugs. In the current economic condition when money is tighter than ever, these medicines can help you cut down a whole lot of healthcare costs. Not many of us are looking into our medicine cabinets to save money, but this is your chance to save up!
Generic drugs tend to cost less than their brand-name counterparts as they do not have to create the medication from scratch. Often people ask, why brand-name drugs are so expensive? Unlike the generic manufacturer, the original pharmaceutical company has to pay for much more than just the production of that medication. A recent study showed that the cost to develop and win marketing approval for a drug is huge. Moreover, the company also pays for the research and development that failed in the trials and could not be brought to the market. Hence, brand-name drugs are more expensive than the generic ones.
As generic medicines do not have to undergo the development process all over again, they cost less. The reduction in upfront research costs implies that generic medicines have the same therapeutic effect as their brand-name counterpart but are sold at a much lower cost. When various generic companies market a single approved product, the prices go even lesser. The competition in the market results in prices about 85% less than the brand-name. Thus, generic drugs are a cost-effective option for those who do not want to spend a huge amount of money on brand-name medicines.
They are safe and effective:
Generic drugs are as safe and effective as the brand-name medicines. Generic drugs have been designed to work in the same way and provide the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. These medicines use the same active ingredient as brand-name medicines and work similarly, hence they have identical benefits as the brand-name medicines.
If you are worried about safety then you need to know that all generic medicines undergo stringent tests before getting approval. The FDA conducts a rigorous review to ensure that the remade drugs meet the safety and quality standards. In addition to that, FDA also carries out inspections of the manufacturing plants where these medicines are made. The examination is carried out with an aim to ensure that the plant is complying with the regulations on good manufacturing practices.
FDA staff also constantly monitors drug products to make sure that the medicines at all levels of the supply chain, from active pharmaceutical ingredients (API) to products being sold to consumers, are safe, effective and high quality. If in case, the drugs are reported to have negative side effects on a patient, the FDA investigates the matter and carries out the appropriate changes required in the use of the drug. Now that you know that generic drugs undergo such rigorous tests, you can be assured that these medicines are highly safe and effective.
They meet the high standards of quality:
Before the drugs are distributed by the generic drug suppliers in India, FDA requires the manufacturers of the drug to demonstrate that the drug can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The drug companies must submit an application that the generic medicine is the same as brand-name medicine in the following ways:
- The active ingredient in both the drugs is same.
- The generic medicine has the same strength, use indications, form, and route of administration.
- The inactive elements of the generic medicine are not harmful in any manner.
- The generic medicine is manufactured under the same strict standards as the brand-name medicine.
- The container in which the medicine will be shipped and sold is appropriate, and the label is same as the brand name’s medicine label.
FDA ensures that generic drugs are manufactured in the same facilities where brand-name drugs are manufactured. It does not approve of drugs that are manufactured in substandard facilities.
They are bioequivalent:
There are many people out there who might question the worthiness and effectiveness of a brand name medicine. It is an obvious fact that generic-brand manufacturers do not just say that the drugs are the same on their own, they carry out certain tests that prove this fact. The medicines need to be tested for bioequivalence.
This process is used to examine how the generic and brand-name medications act on a person’s body. In this procedure, it is evaluated how both of these drugs work in a patient’s bloodstream. For inspection purposes, two separate group of patients are selected, one group of patients is prescribed the brand-name medicine, whereas the other group takes the generic medicine.
The people who participated in the study take the medication and wait for the required amount of time for the medication to start getting absorbed into the bloodstream. After this, the blood samples of the participants are inspected to measure the amount of active ingredient present in both the drugs. The blood samples of the patient are collected over time to see the changes in the concentration of the drug in the bloodstream. The bioequivalence of the generic drugs with brand name medicine can be effectively determined through this test.
Some myths about generic medicine you need to stop believing:
There are three common myths about generic medicine and they are as follows:
- Brand name drugs work better.
- Brand name drugs are safer.
- Generic drugs use low-quality ingredients.
All of these myths are completely baseless as FDA approves generic drugs only after making sure they are effective, safe and the ingredients used are of high quality.
With the help of generic medicine suppliers in India, the generic medicine industry can be taken to the next level. When you choose generic medicine, you can have the assurance that you are making the right choice!