GENERIC MEDICINES

ABSTRACT
After the expiry of patent or marketing rights of the patented drug, generic drugs are marketed.
Generic drugs are available at affordable prices with maintaining quality. These ‘Generic’
formulations balance public interest as critical disease like cancer, AIDS etc. In situations where
demand for medicines exceeds supply, criminally minded people tend to profit out of crime by
manufacturing and distributing counterfeit medicines as а substitute for genuine medicines
(branded and generic). India’s Pharmaceutical market grew at 15.7% during December 2011.
This paper presents various aspects of generic, branded and counterfeit drugs and their impact
on the Indian Pharmaceutical Industry.

Keywords: Generic, Branded, Counterfeit.

1. INTRODUCTION crime by manufacturing and distributing

After the expiry of patent or marketing rights counterfeit medicines as а substitute for
of the patented drug, generic drugs are genuine medicines (branded and generic).
marketed. Generic drugs are available at The consequence of this will be infiltration of
affordable prices with maintaining quality. counterfeit medicines into national
These ‘Generic’ formulations balance public distribution channels.
interest as critical disease like cancer, AIDS India’s Pharmaceutical market grew at 15.7%
etc. It is widely accepted both developed and during December 2011. Globally India ranks
developing countries. An estimated half of all third in terms of manufacturing
prescriptions in the USA are now filed with pharmaceuticals product by volume.1a The
approved generic drugs. In order to market Indian pharmaceutical industry is expected to
drugs, U.S. generic manufacturers must have grow at a rate of 9.9% till 2010 and after that
a permit and approval from the Food and 9.5% till 2015. The Indian pharmaceutical
Drug Administration (FDA) indicating that market is expected to touch US $72 billion
the active ingredient is approximately the sale by 2020 from US $11 billion. The market
same as that of the brand name. The has the further potential to reach US $70
determination of drug approval is made billion by 2020. India ranks 17th in terms of
according to whether it is pharmaceutically exports its product to more than 200
equivalent, bio-available, and bioequivalent. countries around the globe including highly
World Health Organization (WHO) provided a regulated markets of USA, Europe, Japan, and
definition for counterfeit drugs. In situations Australia. The paradox is that despite
where demand for medicines exceeds supply, producing huge pharmaceutical products,
criminally minded people tend to profit out of India has been identified as one among
several developing countries that are time, should be rewarded by taking patent
regarded as the source of counterfeit protection. During this period, the drug
medicines by the organisation for Economic cannot be copied by anybody. After the patent
Cooperation and Development (OECD). is over, the same drug can be copied by
On the other hand, WHO says 3.2% Indians anybody and the costs reduce drastically.
will fall bellow the poverty line will because Many of the anti-diabetic, antihypertensive
of high of high medical bills. 39 million and antibiotic drugs are available now as
Indians are pushed to poverty because of ill ‘Generic’ formulations.
health every year. Around 30% in rural India It’s important to remember that there are
didn’t go for any treatment for financial brand name and generic versions of
constrains. The world health organization medicines like high blood pressure, diabetes,
(WHO) is also worried about Indians high etc. Today about 50% of all prescriptions are
out-of-pocket (OOP) expenses to medicines. filled with generic drugs. The FDA has
This paper presents various aspects of established standards for generic drugs that
generic, branded and counterfeit drugs and might seem complicated but are really simple.
their impact on the Indian Pharmaceutical In accordance with Black's law dictionary,'
Industry. the term "counterfeit drug" may be used to
describe а drug made by someone other than
2. Branded drugs and generic drugs the genuine manufacturer, by copying or
One of the most debated issues in health care imitating an original product without
today concerns the difference between brand authority or right, with а view to deceive or
name (also called branded, innovator, and defraud, and then marketing the copied or
pioneered) drugs and their generic versions. forged drug as the original. In reality,
Evolution of every drug starts from a however, а counterfeit drug is defined
research laboratory and ends in a medical differently in different countries.
shop. Many new molecules are invented in The absence of а universally accepted
research laboratories. Specific definition not only makes information
pharmacological formulations require tedious exchange between countries very difficult but
technology and procedures. Many of such it also limits the ability to understand the true
molecules never achieve final approval. After extent of the problem at global level. In order
formulation of a drug, it is tested on animals to address this problem the following
and then on human volunteers. These quality definition has been developed by the World
controls are stringent and FDA certification is Health Organization (WHO):
necessary for avoiding side effects and "А counterfeit medicine3 is one which is
toxicity of drugs. Only after testing the drug in deliberately and fraudulently mislabeled with
large number of patients in drug trials, the respect to identity and/or source.
drug comes in market. Drug companies spend Counterfeiting can apply to both branded and
lot of money in formulating each drug. Thus generic products and counterfeit products
every drug cost depends on the expenditure may include products with the correct
of the research and procedures of approval. ingredients or with the wrong ingredients,
Every newly launched drug is thus very without active ingredients, with insufficient
expensive to begin with. Companies have active ingredients or with fake packaging."
drug patent of their drug for a specific time According to the FDA, to substitute a generic
period of 10 to 12 years and cost as much as for brand name drug must follow following
2.0 billion dollar. Each year, world wide, only criteria - It must contain the same active
about 25-30 new chemical entities drugs ingredients (the chemical substance that
enter the market1b. These figures2 indicate makes the drug work), the same dosage
that pharmaceutical companies face huge strength (the amount of active ingredients,
difficulties during drug development. Hence for example 20 mg or 40 mg), the same
their investments in research, resources, dosage form (that it, it needs to be available
in the same form as the original – for example in more ways than just being significantly less
as liquid, pill, etc), have same route of expensive. Cheaper does not mean lower
administration (the way the medication is quality.
introduced into the body) and It must deliver The authorized generic5a has identical size,
similar amounts of the drug to the shape, colour, taste, smell, mouth-feel and
bloodstream (that is, it needs to deliver a inactive ingredients as the brand-name drug
comparable amount of drug into the blood- whereas the generic version is different. The
stream within time period as brand name authorized generic provide consumers the
drug). highest brand quality at lower prices and can
According to the FDA, to substitute a generic be marketed during the 180-day exclusively
for brand name drug differences in the period and even the expiry of the product.
following criteria- They look different
(different sizes, shapes, color or markings and 3. Growth of Generic Drug Industry
different names), might have different The generic market reached 100 billion dollar
inactive ingredients. Drugs are made up of in 2010. The generic growth is three times
both active and inactive ingredients. Some higher than the overall growth of drugs. 20
people may be sensitive to inactive drugs will lose patent protection between
ingredients. For example, some people have 2010 and 2014 with the total market value
reactions to certain dyes used in some drugs. 107 billiion dollar5b. According to expectation
The most important advantage with generic of pharmaceutical industry, percentage of
drugs are less expensive than the branded generic drugs in the US market will rise from
versions. They are cheaper as no R & D 14 to 21. This growth will enhance the export
investments are involved as in the case of of pharmaceutical products from India will
branded or new drug. Generic manufacturers double every year. In future contribution
are able to sell their products for lower prices from the Indian pharmaceutical companies
because they are not required to repeat the will increase due to low cost of worker,
costly clinical trials of new drugs and innovation, recent success in track record in
generally do not pay for costly advertising, design operation of high tech manufacturing,
marketing, and promotion. In addition, testing, quality control, research, clinical
multiple generic companies are often testing and biotechnology. Most of the Indian
approved to market a single product; this companies have United States Food and Drug
creates competition in the market place, often Administration (USFDA) approved plants,
resulting in lower prices. So Generics can cost about 20% of all Abbreviated New Drug
between 20 and 80 percent less4. Generics Applications (ANDA) to the USFDA are field
vary by manufacturer (different pharmacies by Indian companies. Now India’s share of the
carry different generics). whether or not generic market is about to 35%. Hence the
generics are always the same as brand is contribution of the Indian pharmaceutical
another question. “Different” doesn’t always industry for the growth of generic drugs in
mean “not as good.” In some cases a generic the world is very high.
drug can be better than the branded version

Table 1: Top 20 Listed Indian Public Pharmaceutical companies (Rank wise 2010)6
Rank Indian Public Rank Indian Public
Pharmaceutical Pharmaceutical companiey
companiey
1 Cilpa 11 Glaxo
2 Ranbaxy 12 IPCA Labs
3 Dr Reddy’s Labs 13 Wockhardt
4 Lupin 14 Torrent Pharma
5 Aurobindo Pharma 15 Sterling Bio
6 Dabur 16 Biocon
7 Sun Pharma 17 Orchid Chemicals & Pharma
 8 Calida Healthcare 18 Alembic
9 Jubilant Life Sciences 19 Aventis Pharma
10 Piramal Healthcare 20 Glenmark Pharma

Over the next few years, an abnormally large are Blockbuster-brand products and offer
number of blockbuster drugs are scheduled tremendous scope to generic manufactures.
to lose their patent protection, opening the
doors to cheaper generic drugs. These drugs

Table 2: List of Blockbluster Drugs Gone Off-patents6

S. No. Drugs business Use Year

1. Concerta (methylphenidate) $1.33 billion. Used for ADHD (attention deficit) in teens. May 2011
2. Levaquin (levofloxacin) $1.63 billion. An antibiotic used for treating bacterial infections. June 2011
3. Zyprexa (olanzapine) $1.97 billion. Used for treatment of schizophrenia and bipolar Oct 2011
disorder.
4. Lipitora (atorvastatin) $6.05 billion. Used for treating cholesterol. Nov 2011
5. Lexapro (escitalopram) $2.56 billion. Used for treating depression. March 2012
6. Seroquel (quetiapine) $3.48 billion. This is an antipsychotic medication. March 2012
7. Plavix (clopidogrel) $4.56 billion. Used to prevent unwanted blood clots to avoid May 2012
heart attacks and strokes.
8. Tricor (fenofibrate) $1.35 billion. Helps reduce cholesterol and triglycerides (fatty July 2012
acids) in the blood.
9. Singulair (montelukast) $3.47 billion. Used for asthma and allergies. Aug 2012
10. Actos (pioglitazone) $2.78 billion. This is an oral diabetic medication. Aug 2012
11 Diovan HCT $1.38 billion. These drugs are used for the treatment of Sep 2012
(valsartin/hydrochlorothiazide) hypertension.

In December’ 2011, Ranbaxy receives Bayer Corp. under the provisions of the
approval for the generic ‘Atorvastatin’ tablets section 84 of the Indian Patent Act 1970. It is
of the original brand name drug ‘Lipitor’ used for the treatment of Liver and Kidney
owned by Pfizer, Inc. cancer. Its price now Rs 8,800 for 120 tablets
In March 2012, Natco Pharma got compulsory (one months therapy) as against Rs. 2,84,428
License (CL) for ‘Sorafenib tosylate’ of the being the cost of ‘Nexavar’ sold by Bayer
original brand name drug ‘Nexavar’ owned by Corp.

Table 3: Top 10 International Generic companies7

S. No. Company Location Revenues in 2010 Growth Over 2009 (%)
(in $ billion)
1. Teva Isreal 11.03 +17.90
2. Sandoz Germany 8.52 +13.70
3. Mylan US 4.99 +7.00
4. Actavis Switzerland 2.52 (estimated) NA
5. Hospira US 2.35 +13.30
6. Watson US 2.27 +38.20
7. Sanofi France 2.04 +41.50
8. Greenstone US 1.72 (2009 revenues NA)
9. Stada Germany 1.50 0.70
10. Dr Reddy’s India 1.16 16.70
NA=Not Applicable P Johnson: $61.6 billion

4. Availability of Generic drugs in the Availability of Generic drugs in the Indian

Indian Market Market is very low. It is only supplied to the
Government and other hospitals or to the generic tested against a brand name drug. In
physician’s dispensary. For more profit, fact, there have been studies in which brand
generally branded drugs are promoted to name drugs were compared with themselves
doctors while branded generics are sold at as well as with a generic. As a rule, the
the Maximum Retail Price (MRP). But difference for the generic-to-brand (Any
distributors buys branded generic from generic drug and brand name drug must
companies at the discount of 10-15% of the perform approximately the same in the body
MRP. In present situation, consumer patients as the brand name drug) comparison was
are not benefited and retail chemists earn about the same as the brand-to-brand
huge profit. comparison.
It is observed in few cases where some
5. Comparative studies people may experience an undesired effect
In a recent study published in the Journal of when switching from brand name drug to a
the American Medical Association, generic formulation or from one generic drug
researchers compared generic and brand- to another generic drug. FDA is actively
name drugs for the treatment of heart and engaged in making all regulated products –
artery disease. The study included beta- including generic drugs – safer.
blockers, diuretics, stains (for high LDL FDA wants to understand what may cause
cholesterol) and warfarin (a blood thinner) – problems with certain formulations if, in fact,
some of the most commonly prescribed they are linked to specific generic products.
medications worldwide. Thirty eight of the FDA is encouraging the generic industry to
studies were randomized controlled trials – investigate whether, and under what
indicative of high reliability. In these studies, circumstances, such problems occur. The
36 of 38 found no real difference between Agency does not have the resources to
generic and brand. perform independent clinical studies and
The decisions of FDA regarding lacks the regulatory authority to require
bioequivalence studies aren’t made public, so industry to conduct such studies.
doctors have no way of knowing when the FDA monitors adverse events reports for
FDA has found a difference and how telling generic drugs. The monitoring of adverse
the difference is. Nor can they find out about events for all drug products, including generic
differences in fillers and other additives, drugs, is one aspect of the overall FDA effort
which might change the rates of release. So it to evaluate the safety of drugs after approval.
comes as no surprise that only 12 of 43 Many times, reports of adverse events
medical journal commentaries on the subject describe a known reaction to the active drug
of generic vs. brand encouraged the use of ingredient. Reports are monitored and
generics. investigated, when appropriate. The
Generic Drugs are available all over the world investigations may lead to changes in how a
at affordable prices with maintaining quality. product (brand name and generic
These ‘Generic’ formulations balance public counterparts) is used or manufactured.
interest like critical disease like cancer, AIDS
etc. FDA does not allow a 45 percent 6. Counterfeiting of drugs
difference in the effectiveness of the generic There are so many factors encouraging
drug product. The average difference in counterfeiting of drugs. Medicines are high
absorption into the body between the generic value items in relation to their bulk and the
and the brand name was 3.5 percent8. Some demand for medicines is very high.
generics were absorbed slightly more, some Furthermore, for the counterfeiter, ingredient
slightly less. This amount of difference would costs can be very low if cheap substitutes are
be expected and acceptable, whether for one used or if these are omitted altogether, as is
batch of brand name drug tested against often the case. Producing counterfeit drugs
another batch of the same brand, or for a may not require building huge infrastructure
or facilities. There are also no overhead costs under conditions that do not comply with
due to quality assurance or meeting Good good manufacturing practices' requirements.
Manufacturing Practices (GMP) standards, In most cases, counterfeit drugs are not
since such standards are never implemented equivalent in safety, efficacy and quality to
and gross margins are therefore very high. their genuine counterparts. Even if they are of
This would require strong government will the correct quality or contain the correct
and commitment to establish and operate а amount of active substance, their production
strong national drug regulatory authority and and distribution are not within the control of
require proper drug regulation (legislation the drug regulatory authority of the country
and regulations) If it does not exist then the concerned. This means that any associated
criminal activity of counterfeiting of defects and adverse reactions will not be
medicines is not treated as а crime. Currently, easily recognized or monitored and, if
only а few of the WHO member states have needed, an effective product recall would not
enacted special national legislation be possible.
addressing the issue of counterfeit drugs. Most nations require generic drug
At present, out of the 191 WHO member manufacturers to prove their formulation
states about 20% are known to have well exhibits bioequivalence to the innovator
developed drug regulation. Of the remaining product. A number of developing countries
member states, about 50% implement drug have made use of compulsory licensing or
regulation at varying levels of development government use orders to enable the supply
and operational capacity. The remaining 30% of more affordable generic drugs in recent
either have no drug regulation in place or а years. India today has the distinction of
very limited capacity that hardly functions. producing high quality generic medicines that
Inadequate resources for drug regulation are sold around the world. India tops in the
activities and absence of training of national world in exporting generic medicines worth
drug regulatory authorities' personnel may of Rs 50,000 core and currently, the Indian
also manifest itself as inefficiency and pharmaceutical industry is one of the world's
incompetence of national drug regulatory largest and most developed
authorities. The efficiency of personnel is The detrimental impact of this description of
adversely affected by corruption and conflict counterfeit drugs on Indian generic industry
of interest resulting in laws not being is very emphatic as situations here are also
enforced and criminals not being arrested, paradoxical. India on one hand has been
prosecuted and convicted for their crimes. identified as one among several developing
lntersectoral cooperation between regulatory countries that are regarded as the source of
authorities, police, and customs services and counterfeit medicines by the organisation for
the judiciary is essential for effective control Economic Cooperation and Development
of the national drug market and enforcement (OECD). India is the fourth largest producer
of drug legislation. of pharmaceuticals in the world which
Pharmaceuticals made for export are not accounts to 8% of world’s production by
regulated by many exporting countries to the volume and 1.5% by value. India
same standard as those produced for pharmaceutical industry ranks 17th in terms
domestic use. Trade in pharmaceuticals of exports its product to more than 200
rarely takes place between the manufacturing countries around the globe including highly
country and the importing country. Currently, regulated markets of USA, Europe, Japan, and
it takes place through one or more Australia. According to Gold Saches study, it is
intermediate countries or trading houses. estimated that India is estimated to be the
Activities in trading houses may sometimes fifth largest pharmaceutical market in the
involve repackaging and re-labeling which world by 2020.
may be carried out without any controls In order to market drugs, U.S. generic
manufacturers must have a permit and
approval from the Food and Drug generics as therapeutically equivalent or non-
Administration (FDA) indicating that the equivalent. Because the antibiotic protocol
active ingredient is approximately the same uses such low doses, leeway between
as that of the brand name. The determination versions which are effective and those which
of drug approval is made according to are not may be much more critical.
whether it is pharmaceutically equivalent,
bio-available, and bioequivalent. 8. Bioavailability
In bioavailability, it can be assumed that the
7. Pharmaceutically Equivalent drug's effectiveness is related to the amount
Two drugs are considered pharmaceutical of product absorbed and the speed of
equivalents when they contain the same absorption. However, in some cases, the
chemically active ingredient(s) and are pharmaceutically equivalent products can
identical in dosage form and strength. have different bioavailability. They may be
Pharmaceutical equivalence may be affected absorbed either faster or slower than the
by many things. brand name drug which may or may not be
1. Variations in inert ingredients clinically significant.
2. Plants in different parts of the world The pH-dissolution profile of a product may
3. In oral drugs, capsule content may be have clinical relevance. Even if the coating is
7% over or 7% under the stated adequate to prevent release of the enzymes in
content, e.g. a 100 mg. capsule may be the stomach where the ingredients are
as low as 93 mg. or as high as 107 mg. irreversibly inactivated, it may not dissolve at
4. Manufacturers may shift their source the pH of the duodenum after meals.
of supply.
5. Once a drug has been approved by the 9. Bioequivalence
FDA, manufacturers sometimes make In bioequivalence studies, the goal of testing
changes to the formula which was is to determine if the drugs are functionally
originally submitted. equivalent. The FDA requires that any
6. Many arthritic patients are elderly. approved drug be effective within a 20%
The age of the patient may be a factor range of the original patented or brand name
in pharmacokinetics. Digestive tract drug. This means that the effectiveness may
absorption of an oral drug may be be 20% greater or 20% less effective than the
altered by a variety of factors, brand name so that two generic drugs could
including higher gastric pH, contain as much as a 40% difference from
accelerated gastric emptying, and each other. Therefore, a drug may be legally
thinning and reduction of the chemically equivalent but not at the same
absorptive surface. time clinically equivalent. A study run on a
generic of the anti-seizure, Tegretol, found
In addition to general approval, the FDA rates the generic allowed breakthrough seizures.
drugs with codes. All drugs with an "A" code An example of how the above factors may
are rated as being therapeutically equivalent; affect the bioavailability and clinical
"B" coded drugs are those not rated effectiveness is seen by applying these factors
equivalent some pharmacies fill with B-rated to tetracycline. At one extreme, a 500 mg.
drugs. At this time, it is recommended that no dose of tetracycline taken in 2-250 mg.
patient use a version of a drug with a B- capsules which is 20% lower in effectiveness,
rating. Clinical differences or serious 7% low in the mg. amount in each capsule
bioequivalence problems with B-rated (14% dose total) and which is taken with
products have been reported for drugs such food, decreasing the absorption rate (<50%),
as prednisone, estrogen tablets, levodopa and could provide as low as 136 mg of
phenytoin. In addition to The Orange Book9, tetracycline that is available to the body.
The Physician's Generics lists available Correspondingly, the same 2-250 mg.
capsules making a total dose of 500 mg. on healthy volunteers and thus may not
which is 20% more effective, 7% over on mg. account for the full pharmacologic and
in capsule and taken without food (increasing therapeutic impact of generic substitution on
the absorption rate to 77%), provides 555 mg patients with disease.
that is functionally available to the system. It Most nations require generic drug
should be noted the food-drug interaction is manufacturers to prove their formulation
less a factor with minocycline and exhibits bioequivalence to the innovator
doxycycline as they are absorbed differently. product.10-15 In the U.S., the FDA must
In addition to the ±20% difference allowed in approve generic drugs just as innovator drugs
bioavailability by the FDA and the ±7% of the must be approved16. The FDA requires the
stated capsule content allowed by the U.S. bioequivalence of the generic product to be
Pharmacopoeia, there are other between 80% and 125% of that of the
considerations which should be considered innovator product.17
when using a generic drug. This value range is part of a statistical
calculation, and does not mean the FDA
1. Some drugs lose potency while on the allows generic drugs to differ from the brand
shelf, so drug companies increase the name counterpart by up to 25 percent. FDA
strength so as the drug ages, it will recently evaluated 2,070 human studies
still provide a therapeutic level. This conducted between 1996 and 2007, which
means patients who use the drug soon compared the absorption of brand name and
after production when the dose may generic drugs into a person’s body; they were
be stronger may be getting an submitted to the FDA to support approval of
overdose. generics. The average difference in
2. There is a risk that a generic absorption into the body between the generic
substitution could result in a change and the brand name was 3.5 percent,
in serum concentration. comparable to differences between two
3. Such a change may lead to significant different batches of a brand name drug.18, 19
adverse effects or loss of benefit. Bioequivalence, however, does not mean
4. The risk that patients may receive generic drugs must be exactly the same
different generics each time they fill (“pharmaceutical equivalent”) as their
their prescription, changing the innovator product counterparts, as chemical
response to the drug. differences may exist (different salt or ester –
5. Cost of brand names is usually, but a “pharmaceutical alternative”).
not always, higher than for a generic. A physician survey in the US found only 17%
6. Blood tests can become necessary to of prescribing physicians correctly identified
determine adequate concentrations, the USFDA's standards for bioequivalence of
excessive, possibly toxic generic drugs.20
concentrations or low, possibly A latest development to address this issue
ineffective concentrations. enables interested doctors and consumers to
7. The cost of the time and effort spent check generic drug interactions and outcomes
in adjusting the dose (if needed). detail to the specific drug and drug company.

Bioequivalence may be affected by the type of 10. The WHO Executive Board Meet
study; e.g. two brand name pharmaceutical The most controversial part of definition of
equivalents were each compared with a counterfeiting of drugs is that any ‘false
placebo in separate trials but were not representation’ in relation to ‘identity, history
compared with each other for bioequivalence. or source’. False representation of identity
Thus while each was effective, it cannot be and source applies not only to mere labeling
assumed that they produce the same clinical of the products, but also to container or other
effect. Bioequivalence studies are performed packaging’. Thus, false representation with
regard to any of these would make the Act, standardized U.S. procedures for
product ‘counterfeit within the scope of the recognition of generic drugs. An applicant
definition. The WHO Executive Board meeting files an Abbreviated New Drug Application
in Geneva in January 2009, India’s (ANDA) with the Food and Drug
suggestion’s were accepted and the word Administration (FDA), and seeks to
‘history’ was deleted and modify the present demonstrate therapeutic equivalence to a
defination.21 specified, previously approved “reference
India has stressed that a generic or branded listed drug”. When an ANDA is approved, the
medicine not registered in a particular FDA adds the drug to its Approved Drug
country, but available in that country is not Products list, also known as the Orange Book,
counterfeit, but simply an unregistered and annotates the list to show equivalence
product.22 between the references listed drug and the
approved generic. The FDA also recognizes
Patient Perspective drugs using the same ingredients with
• Cost and compliance. Theoretically, different bioavailability, and divides them
generic medications should improve into therapeutic equivalence groups. For
management and patient compliance because example, as of 2006, diltiazem hydrochloride
the obstacle of cost has been removed. had four equivalence groups, all using the
• Inferiority complex. Another potential same active ingredient, but considered
issue is that patients may be resistant to equivalent only within a group.23
going on a generic medication because they
perceive them as inferior to their branded 12. Patent System in the US
counterpart.22 Generics are often considered After getting the FDA approval for marketing,
second-rate medications due to perceived the drug innovator company may apply for
poor compliance with standard manufacturing process and grant of
manufacturing practices, lack of patient exclusively rights for about 20 years. The
knowledge about generics, and influence of Patient Protection and Affordable Care Act
the brand-name company.22, 23 We need to 2010 authorized FDA to approve generic
educate our patients so they can make an versions of biological manufacturers 12 years
informed decision about their treatment and of exclusive use before generics can be
be willing to try a generic medication if the developed. On the other hand, after January 1,
situation is appropriate. This is particularly 2005, India enacted an amendment to its
true in the elderly who may be on multiple patent law that reinstated product patents for
medications, as well as those with low the first time since 1972. The legislation took
socioeconomic status who could benefit from effect on the deadline set by WTO’s Trade
the savings. Related aspects of Intellectual Property Right
• Patient preferences. We often need to (TRIPs) agreement, which mandated patent
consider our patient’s personality and past protection on both product as-well-as
experience when deciding between generic processes for the period 20 years. Under this
and brand drugs as well. One important new law, India is forced to recognize not only
question to ask our patients is whether they new patents but also any patent filed after
have taken generics before and what the January 1, 1995.
outcome was. If the patient had a poor
experience, they may be biased towards 13. Challenging patents
branded medications and willing to pay the Brand-name drug companies have used a
higher price. number of strategies to extend the period of
11. U.S. generics approval process market exclusivity on their drugs, and
Enacted in 1984, the U.S. Drug Price prevent generic competition. This may
Competition and Patent Term Restoration involve aggressive litigation to preserve or
Act, informally known as the Hatch-Waxman extend patent protection on their medicines,
which is called ‘ever greening’ of patents. warning labels when significant new risks
Drug companies may seek new patents on the emerge. The financial and safety implications
production of specific forms of these from the court's ruling could prove decisive.
compounds, such as single enantiomers of
drugs which can exist in both “left-handed” 16. CONCLUSION
and “right-handed” forms,24 different inactive In situations where demand for medicines
components in a drug salt,25 or a specific exceeds supply, criminally minded people
hydrate form of the drug salt. 26 If granted, tend to profit out of crime by manufacturing
these patents ‘reset the clock’ on patent and distributing counterfeit medicines as а
expiration. These sorts of patents may later substitute for genuine medicines. Also,
be targeted for invalidation (“paragraph IV consumers who use medicines
certification”)27 by generic drug inappropriately generate demand for such
manufacturers.28-30 medicines, the sources of which may be
The USFDA offers 180 days exclusively period counterfeit. In many cases counterfeit drugs
to the first successful generic manufacture, have been found to be without active
who argues that a patent is invalid or dose ingredients, or with wrong ingredients or
not violate the production of the original with incorrect quantities of active
drug. After this exclusivity period, other ingredients. Treatment with ineffective
manufacturers can enter the market. As a counterfeit drugs such as antibiotics can lead
result that further lowers the price of the to the emergence of resistant organisms and
drug due to competition. may have а deleterious effect on а wide
section of the population. In extreme cases,
14. Prescription in the US counterfeit drugs may even cause death.
A pharmacist may legally fill a prescription in As а consequence of such damaging effects,
the United States with either the brand name counterfeit drugs may erode public
or a generic without consulting either the confidence in health care systems, health care
patient or the physician. A prescription may professionals, the suppliers and sellers of
not even be filled consistently with the same genuine drugs (branded or generic), the
generic. To assure continuity for the patient, pharmaceutical industry and national Drug
the physician should indicate on the Regulatory Authorities (DRAs). Incorrect
prescription no substitutions or dispense as labeling as to the source can also be
written. detrimental to the reputation and financial
It must keep in mind that it is not to assume standing of the original and/or current
that all drugs with the same generic title are manufacturer whose name has been
equal and will have the same clinical effect, fraudulently used. The consequence of this
even though many drug reps say they are will be infiltration of counterfeit medicines
equal. into national distribution channels.
There is no simple solution or remedy that
15. Litigation and U.S. Supreme Court can be applied to eliminate counterfeit
ruling medicines nor can the problem be solved by
Two women, who claimed to have suffered an individual company or government. The
severe medical complications from a generic problem has reached а global dimension and
drug, lost their Supreme Court appeal on needs а global approach. Governments need
Thursday, June 23, 2011, essentially ending to develop strategies to reduce corruption
their separate lawsuits against and powerful act counterfeiting legislation.
pharmaceutical manufacturers.
The justices in a 5-4 ruling said generic drug
companies do not share the same level of
responsibility as makers of brand-name
equivalents and do not have to update their