Since long, it has been a matter of debate and discussion among healthcare providers about the merits, demerits, adoptability, therapeutic efficacy, physicians' prescribing pattern, and patients' inclination for brand named drugs and generic drugs. Various factors are resposible for governing the option for each category. Physicians and patients have got natural preference for brand-named drugs due to obvious reasons. On the other hand, in the changing scenario, a switch-over is being observed and now generic world is rapidly becoming favourite choice for all concerned. Generic drugs are making rooms into the global pharmaceutical market.
Drugs for patients
There are numerous factors which affect the choice of drugs with respect to the patients. At the point of selection of the drugs for therapeutic purpose, a patient considers these factors before taking any decision. Such factors are given under:
Cost effective drugs: It is one significant factor which is considered by most of the patients particularly when they are opting for self medication. It becomes more and more prominent when we talk about a country like India where still majority of population is categorized below poverty line. An average Indian patient finds himself unable to afford costly drugs (majority of such drug belongs to brand name drugs) and under such circumstances he prefers to remain untreated rather than continuing the treatment with costly drugs.
Ease of availability: As per an average patient a drug should be available at right time and at right place. Certain drugs are available only at big outlets located only in metro cities. Medical stores located at small towns and villages generally remain short of supply of such drugs and patients face lot of difficulty to procure such drugs.
Desired therapeutic action: Exerting desirable therapeutic effect is the most important characterstic of the drugs which a patient looks for.
Minimum side effects: A drug with minimum side effects is generally preferred by the patient for the treatment of particular disease.
Ease of administration: Though seldom, this factor also affects a patient choice for a particular drug. It is of more prominance when it comes to children and giartric patients.
Motto of pharmaceutical care: All the healthcare providers are morally bound to provide adequate pharmaceutical care to patients. Pharmacist plays crucial role in affecting a patient's choice of drug by imparting appropriate patient counseling and by dissaminating relevant drug information.
Options before patients
When it comes to the therapeutic treatment of a particular disease, a patient does have following options to go ahead with:
Prescription drugs: For opting such class of drugs a patient goes to physician for therapeutics treatment and physician prescribes certain drugs which a patient purchases from the medical store. It is most widely excercised option of the treatment of the desease all over the world.
Non prescription drugs: Generally over the counter drugs belong to this category. Such drugs are displayed over the counter in medical stores and patients purchase them without prescription by a physician.
Self medication: Patients with this option have some previous knowledge and experience about the drugs and diseases. They decide about the drug to be used in a particular desease at their own and go for purchasing them.
Generic drugs
A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, which is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights. A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. Generic drugs can be defined as a substitute or a bio equivalent of a branded drug satisfying the pharmacokinetic and pharmacodynamic standards. A generic name is the actual chemical name of the drug with respect to the chemical ingredients present within the drug.
Essential criteria
● Generic drugs can be legally produced for drugs where:
● The patent has expired,
● The generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed,
● For drugs which have never held patents, or
A generic must contain the same active ingredients as the original formulation.
● According to the US Food and Drug Administration (FDA), generic drugs are identical or bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties.
● Generics are identical in dose, strength, route of administration, safety, efficacy, and intended use.
Brand named drugs
A branded drug has a trade name and does a well-established pharmaceutical company, protected by a patent, manufacture drug. It cannot be produced or sold by any other company. A drug that has a trade name and is protected by a patent (can be produced and sold only by the company holding the patent) comes under this category.
Brand named drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
The "active" ingredients (the basic chemical composition) of a brand name drug and its generic equivalent may be same. However, there can be differences in the colour(s) used in the drug, and other similar "inactive" ingredients. It has been observed that drugs that are sold under specific brand names are usually costlier than the ones that are sold under their generic names.
Characteristic features
● Brand named drugs are found to be costlier than drugs sold under their generic names.
● A brand name will be simpler than the generic name.
● Some brand named drugs may be more easily absorbed by the body.
● Brand named drugs may cause fewer or weaker side effects.
● Drug companies spend a lot of cash on advertisements. Huge amount is invested for popularizing the drugs.
SWOT analysis
Generic drugs
Strengths
● Economical production.
● Low price of finished product.
● Therapeutically equivalent.
● Low expenditure on advertising.
● Low expenditure on research and devolopment
Weaknesses
● Difficult to remember generic names.
● Physcian as well as patient are hesitant and reluctant to prescribe and use generic drugs.
● Less popular among users and majority of the users do suffer from lack of awareness with regard to the therapeutic efficacy.
Opportunities
● A chage in prescribing habits of physicians as well as purchasing habits of customers is being observed and favourable circumstances are there for the generic drugs to make rooms in the existing pharmaceutical marketing scenario.
● The pharmaceutical industry is focussing attention on increased production of generic drugs.
Threats
● Wide spread flow of information about the features of generic drugs among all concerned is need of the hour otherwise there may not be sufficient inclination towards generic drugs.
● The fact that generic drugs are bioequvalent to brand named drugs is required to be highlighted.
Brand named drugs
Strengths:
● Heavily advertised and publicised.
● Frequently prescribed
● Highly popularised and names are easy to remember.
● Huge investment and focus on marketing aspects.
● Generated faith and trust in patients as far as therapeutic effect and quality of the drug is concerned.
Weaknesses
● Costly and expensive
● Huge investments by company on the research & development and marketing aspects.
● High competition among players.
● Patients may be in problem in case of non-availability of drug.
Opportunities
● The trust of physcians and patients can be intensified.by adopting strategies for cost reduction.
● Thearapeutic efficacy can be enhanced through research and development efforts.
Threats
● People may switch over to generic drugs considering the cost factor.
● The government may adopt negative attitude particularly the countries of third and fourth world.
Some common myths
● Generic drugs are therapeutically less effective.
● Generic drugs are of substandard and low quality.
● Physicians do not prefer to prescribe generic drugs.
● For treatment of certain diseases generic drugs are not available.
● There are very few companies which manufacture generic drugs.
● Generic drugs are not bioequivalent to brand named drugs.
Obvious reasons to opt for
There are obvious reasons to justify the use of generic drugs which are resposible for the growing popularity of these drugs. Some of such reasons are mentioned here under:
● Comparatively cheaper prices of generic drugs mainly account for their acceptance by physcians and patients when compared with the brand named drugs. The principal reasons for the relatively low price of generic medicines are:
● That competition increases among producers when drugs no longer are protected by patents.
● Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers.
● Generic drug manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions.
● Generic drug manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company.
● Generic drug companies may also receive the benefit of the previous marketing efforts of the brand named drug company, including media advertising, presentations by drug representatives, and distribution of free samples.
● Generic drugs naturally become drugs of choice when the treatment is long-term, particularly in chronic deseases. Under such circumstances, physicians or health plans adopt policies of preferentially prescribing generic drugs because the therapy involves various steps and levels.
● Generic drugs introduce competition in the market which prevents any single company from dictating the overall market price of the drug. Hence, generic drugs play an important role in governing the monopoly of brand named drugs.
● On certain occasions physicians adopt policies of preferentially prescribing generic drugs as in step therapy. The reason could be attributed to the low price of generic drugs.
● Promotion of generic drugs has become inevitable in the rapidly changing competitive global environment where survival in isolation is very difficult and generic drugs are being regarded as pacemaker for pharmaceutical industry all over the world.
Generic drugs: The govt factor
Government is one agency which can remarkably influence the production, sales promotion and acceptance of generic drugs in the pharmaceutical arena. The announcement and the implimentation of rules and regulation as well as legislations laid down by the government from time to time with regard to the drug price and its productuion are of vital significance. In a democratic country like India the role of government in controling drugs in the mentioned respects becomes even more important. If we talk from the point of view of patients having week economic backgrounds, for them, it is pleasant surprise that the Indian government is adopting a flexible approach as far as drug policies are concerned. It appears that in current times, in comparision to brand named or brand named drugs, the generic world is on an edge if we analyze the Indian pharmaceutical market scenario. Being democratic in nature, in India, the government is morally bound and committed to provide cheaper and quality drugs to the patients and to attain this objective the government is left with no other option except to promote the generic drug market. Another reason for promoting generic drug market is that in this competitive global environment, one cannot survive in isolation and we have to march past with rest of the world if we have to remain in the race.
Conclusion
It is crystal clear that dilemma still persists with regard to the use of generic drugs when it comes to physicians, pharmacists and patients. Despite of massive popularity, huge publicity and strong marketing network in case of brand named drugs, a switch over is being observed and due to certain and obvious reasons generic drugs are rapidly emerging as alternative to brand named drugs. Price seems to be the prime factor apart from other benefits of generic drugs. The edge of generic drugs over brand named drugs appears quite justified when we talk about global environment particularly for a developing nation like India where still 2/3rd of total population is categorised below poverty line. Nevertheless, the significance and relevance of brand named drugs can't be ignored.
(The authors VK Sharma, Pranav Sharma, Lubhan Singh, VP Yadav are with D. J. College of Pharmacy, Modinagar (U.P.). and Kamal Dua is with International Medical University, Malaysia)