Branded medicines and generic drugs

Branded medicines and generic drugs

 

A branded medicine is the original product that has been developed by a pharmaceutical company. When a company develops a new medicine, their product must undergo and pass rigorous tests and evaluations to ensure that it is both effective in curing the condition it claims to treat and safe for human use. Because pharmaceutical companies invest considerable amounts of money to develop a new medicine, they are given the sole right to manufacture the medicine for a period of time. When a pharmaceutical company is given sole rights of manufacture, the medicine is said to have a patent on it. A patent is a technical description of what the drug is and what it is used for. For a period of time after the patent is granted, no one else can produce a drug that is the same as the patented drug; the medicine belongs exclusively to the original company. For this reason, branded medicines are the most well known and most trusted type of that particular medicine.

A branded drug is protected by a patent and has a trade name. The drug cannot be manufactured or sold by any other company. The rate is fixed by the company. New drugs are generally developed under patent protection. Branded drugs are manufactured by conforming to global standards. Brand name drugs are usually given patent protection for years from the date of submission of the patent.  A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect. This provides protection for the innovator of such drugs to make good the initial costs incurred by him, viz., research and development and marketing expenses to develop the new drug.

A branded generic drug is a name given to a type of drug by the manufacturing company. The use of the name given is strictly reserved for its owner company only.  A branded generic drug is a drug that is bio-equivalent to the original product, but it can be marketed under another company’s brand name. The use of the name is reserved exclusively for its owner.

According to experts the brand-name medications are not always better. Many of them are highly expensive, As a result of this high cost, some people may skip doses or not take a drug at all because they just can not afford it. In this way, generic drugs may be a clear winner. In many places pharmacists are required to provide patients with the generic version of the medication, unless patients’ doctors specify. It is estimated that if more prescribers substituted generic drugs for brand-name drugs, drug spending could drop substantially. In addition, there is really no hard proof at this point that generic medications are any less effective than the originals. These drugs are heavily regulated, which can give patients some assurances about quality.

Are branded medicines better than their generic counterparts? Studies say no. If you had a fever, you would most likely rush to the nearest medical store and buy a ‘Crocin’ or any other brand of paracetamol. But, if you were given a plain pill of paracetamol, without any brand name on it, perhaps you would think twice before taking it. In an attempt to understand this, many researchers from various health institutes have assessed the quality of generic medicines and their branded equivalents. The research was part of a larger study to understand the how to improve equitable access to medicines for patients, generic medicines being an important way to do so. Using qualitative analysis, the researchers also developed a framework that explains the role of trust in improving access to medicines. “We knew from our research that improving the availability of generic medicines was not enough to increase its consumption. We also had to address the trust in medicines and in health services to improve access,” say the researchers of the studies.

Generic drugs

A generic drug is a drug defined as “a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics and intended use”.  It has also been defined as a term referring to any drug marketed under its chemical name without advertising. Although they may not be associated with a particular company, generic drugs are subject to the regulations of the governments of the nations where they are dispensed. Generic drugs are labeled with the name of the manufacturer and the adopted name (non-proprietary name) of the drug. A generic drug must contain the same active ingredients as the original formulation. According to the US FDA, generic drugs are identical or within an acceptable bio-equivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.

Generic drugs are marketed without brand names and are normally less in price compared to branded medicines. Both generic drugs and branded medicines are chemically identical and meeting the same standards of the US FDA in its safety, purity, effectiveness. Generic drugs are marketed under an approved name rather than a branded name. Generic drugs are frequently as effective as, but much cheaper in cost than branded medicines. A simple example is that paracetamol is a chemical ingredient found in a number of branded name painkillers, but it is also sold as a generic drug – not sold under a brand name – because of its low cost, generic drugs are often the only drugs that the common people can afford.

Many people become concerned because generic drugs are often substantially cheaper than the brand-name versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. The US FDA requires that generic drugs be as safe and effective as brand-name drugs. Actually, generic drugs are only cheaper because the manufacturers have not had the costs of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research & development, marketing and promotion of the drug.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.  In other words, their pharmacological effects are exactly the same as those of their brand-name drugs. They are equivalent in terms of safety, dosage, strength and quality. When a generic drug product is approved, it has to meet the standards established by the US FDA with respect to identity, strength, quality, purity and potency. Generic drugs must have the same active ingredient, strength, dosage from and route of administration as the brand name. But, generic drugs may not contain the same inactive ingredients as that of brand name. The generic drug must be bio-equivalent to the drug of brand name. The generic drug must perform the same function as that of branded drug, ie. they have to treat the same medical condition. The generic drug should absorb into the bloodstream at a similar rate and over the same period of time as the brand-name drug.

Developing of generic drugs

In developing generic drugs, the manufacturer must prove the bioequivalence of the drug with that of branded drug. The purity, consistency and strength have to be maintained. In this process there is no involvement of lengthy and other expensive clinical trial process except the bioequivalence tests. Thus generics can take only about maximum of three years as compared to the branded drugs which takes about six to seven years for the development. Generic drugs are often manufactured by companies that also make brand-name drugs. The US FDA regulates and inspects all generic drug manufacturers as that of branded drugs. If any marketed products fail to meet their production standards, they will be recall by the US FDA.

Benefits of generic drugs

The main benefit of generic drug is cost saving; therefore, drugs can be available at affordable prices.  The cost is 80-85 per cent less than the branded drugs. The drug is sold at lower prices because they are not required to repeat the costly clinical trials, high marketing, advertising and promotion cost. The cost difference is such that the generic drugs can be easy affordable.

Scope of generic drugs

Due to increase in disease conditions such as diabetes, heart diseases, etc manufacturing of generic drugs are also increasing due to low costs affordable by the patients. Taking advantage of shortcoming in patent application of patent holders, leading Indian pharmaceutical companies can introduce generic drug of its own.

Use of generic drugs

In India, there are many wrong impressions about the quality of generic medicines, compared to branded medicines. Statements such as ‘the more you pay, the better the quality’ are often the basis on which generic medicines are weighed down. The US FDA requires that generic drugs are manufactured with the same strict standards as their brand name drugs. “The FDA conducts more than 3500 inspections of manufacturing units to ensure generic drugs are bio-equivalent. Bio-equivalent = when two drugs have the same result – meaning that generic treatments are just as legit and safe as the brand-name versions. Generic drugs are subject to the same US FDA oversight as brand name medications and the same standards of potency and purity. So, then if they are the same thing. That is why they are literally 80-85 per cent cheaper than brand name drugs. In US, 80 per cent of the prescription filled drugs are generic drugs. Thus the cost of the prescription can be lowered. These drugs have the same strength, dosage and quality of the branded drug. In the drug store pharmacists refer to the drug indexes like Current Index of Medical Specialties to find out the active ingredient and then dispense from the available stock from the hospitals. Pharmacists also play a vital role in educating the doctors about the availability of generic drugs. Thus the right medication could be given to the patients at the best possible price. In countries like the US or the UK, community pharmacists play an important role in dispensing medicines and hence their cost awareness becomes crucial. But in India, the concept of community pharmacists does not exist and hence the onus for cost reduction, from the point of view of drug selection, lies with the doctors.

Conclusion

Expense of medicines is a major concern today. Generic drugs provide major saving opportunity in healthcare cost since they usually have lower cost. However, doctors and patients are apprehensive regarding their quality, although they are bio-equivalents of the innovator products. With the sky-rocketing healthcare cost, the interest in generic drugs usage has raised across the globe, amongst rich or poor. Generic drugs enable major savings in healthcare cost since they are usually substantially lower in price than the innovator brands. Generic drugs are effective, safe and bioequivalent as that of branded drugs. Generic drugs are less risky than new drug therapies. Due to expiry of patents of branded drugs, more generic drugs can be formulated with fewer prices. Many multinational companies are investing in such generic drugs to cater to the needs of people across the globe at affordable cost.

Give a Reply