In low- and middle-income countries, originator brand medicines generally cost substantially

more than their generic equivalents. Patients purchasing medicines in the private sector pay,
on average, 2.6 times more for originator brand than for their lowest-priced generic
equivalent. In some low- and middle income countries, this price differential is more than 10-
fold. When generic medicines are of assured quality and are offered at lower prices than the
corresponding originator brand product, there is a potential for patients and health systems to
achieve equivalent health outcomes at a lower cost. The use of generics is therefore often
promoted in the public and private sectors to reduce medicine costs, and increase product
availability and consumer access.1

A generic drug is identical, or bioequivalent, to a brand name drug in dosage form, safety,
strength, route of administration, quality, performance characteristics, and intended use. On
expiration of the originator product’s patent term protection, other manufacturing companies
may file submissions to regulatory authorities for approval to market generic versions of the
originator medicine. Generic drugs may be marketed under the non-propriety name or as a
branded generic. Branded generic drugs have names derived from a combination of the
manufacturer’s name and the non-proprietary name. This enables the manufacturer to market
the product in a way similar to the proprietary product.2 Generic drugs are cheaper in
comparison to branded drugs because there is no need to make investments in R&D as in the
case of new drugs. The prevailing fierce competition also makes the manufacturers keep to
low prices.3 Currently, fast moving branded medicines are manufactured by MNCs or large
Indian companies. The branded medicines are usually expensive as they are strongly
promoted through doctors and chemists and such promotional costs add to their retail prices,
i.e., Maximum Retail Price (MRPs). The practice of bribing doctors by pharmaceutical
companies to create more and more prescriptions is not recent in the country as well as world

1
Cameron A, Laing R. Cost savings of switching private sector consumption from originator brand medicines to
generic equivalents. World health organization report; background paper. 2010; 35:210-5.
2
King DR, Kanavos P. Encouraging the use of generic medicines: implications for transition economics. Croat.
Med. J.2002; 43(4):462-469.
3
Dadhich A, Upadhyaya M. A review: exploring branded generic drugs by Indian pharmaceutical multinational
companies as a new prospect. Pharmacophore 2011; 2 (6): 271-275
over. The unethical promotional practices being adopted by the companies make the essential
medicines unaffordable to common man.4

One of the many ways to control healthcare expenditure is to promote the use of cheaper
generic drugs instead of the more expensive branded equivalents. Savings made by using
generic medicines allow more patients to be treated with the same amount of money and
mobilizes fund to finance other treatment modalities.5 While manufacturing generic drugs,
the drug companies use the same active ingredients and are shown to work the same way in
the body, they have the same risks and benefits as their brand name counterparts. Also,
generic drugs have the same quality, strength, purity and stability as brand name drugs. It is
seen that Generic Drugs work in the same way and in the same amount of time as branded
drugs. New drugs are generally developed under patent protection. The patent protects the
investment and the associated expense, viz. research, development, marketing and promotion.
When patents are nearing expiration, manufacturers usually approach the Government/Drug
Control Department to sell generic versions. In the process, the consumers get genetic drugs
at substantially lower costs. Both branded and generic drugs are manufactured by conforming
to International standards. Brand name drugs are usually given patent protection for 20 years
from the date of submission of the patent. This provides protection for the innovator of such
drugs to make good the initial costs incurred by him, viz., research development and
marketing expenses, to develop the new drug. Many drug companies start manufacturing
generic drugs once the patent licence expires for a branded drug. There are only rare
circumstances where substituting a generic drug for a brand name product (or vice versa) may
not be appropriate for a particular patient. For some patients, generic substitution may be
inappropriate due to reactions to inactive ingredients or problems with the pill shape, colour
or related characteristics. Patients should become assertive and insist upon the doctors to
prescribe generic drugs if available, so that the patient would get the product at the best
possible price. 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. Thus if generic drugs are bought by the patient, the patient may not lose

4
Singhal GL, Kotwani A, Nanda A. Jan aushadhi stores in India and quality of medicines therein. Int J
Pharmacy Pharm Sci. 2011; 3(1):204-207.
5
Chua GN, Hassali AM, Shafie AA, Awaisu A. A survey exploring knowledge and perceptions of general
practitioners towards the use of generic medicines in the northern state of Malaysia, Health policy 2010; 95:
229-235
money by going in for branded drugs, which are too costly.6 The essential drug concept
adopted in many developing countries promotes use of generic medicines, the main reason
for generics is drug price containment through competition to improve access to essential
medicines.7

According to a survey approximately one quarter of physicians expressed concerns about

efficacy, almost half reported concerns about quality, and approximately one quarter do not
prefer to use generics as first line medications for themselves or for their family. Because of
the vast cost differences between generic and brandname drugs, these negative beliefs could
have important implications for national health-care expenditures.8

The growth of generic market is more than 12 per cent each year and this is because of
increasing number of patent expiries. However, the penetration of affordable generic
medicines in the Indian market is very low and restricted to government hospitals only. The
industry, the government and the medical profession are urged to support the generic
movement in India and, thus, make available and affordable generic drugs for all patients. 9

6
Bakthavathsalam G. Generic drugs: Cost effective alternative to branded drugs. Health Adm.; 9(1): 16-19
7
Olusola AM, OlubukolaOO, EmekaOH, Lilian AE. Equivalence of two generic brands of amlodipine besylate
under biowaiver conditions, Int J Pharmacy Pharm Sci. 2012;4(2):265-268.
8
Shrank WH, Liberman JN, Fischer MA. Physician perception about generic drugs, the annals
pharmacotherapy. 2011 Jan; 45:31-38.
9
Gattani OR. An overview: Branded to Generic Drugs. The Indian Pharmacist. 2012 Jun: 15-21.
We know that brand name drugs are expensive. That is why it has been developed many
generic drugs with the same active ingredients of the popular brands. This has boomed
because it is a relief to the consumer’s pocket. Some prefer not to trust them but others
choose them because of the low price.

For a generic drug is released to the market, the drug must exist for brand name drug before.
This medicine tends to be a very expensive, since they have processing costs that are required
for preclinical and clinical researches and promotional campaigns. For this they have 10 years
of marketing exclusivity, during which time they can recover the costs invested. After those
10 years laboratories authorized health requirements use the same active ingredients to
produce very similar to trade name drug, but at a lower cost.

Here are some advantages and disadvantages of the use of generics:

Advantages

1. Cheaper prices: The main reason so many people buy generic drugs is because they
are so much cheaper than brand name drugs. Brand name drugs require research and
testing that take a lot of time and money but generic drugs only need to copy what
already exists, saving them the cost and allowing the price to stay low.
2. Bio-equivalent : Biologically speaking generic drugs must meet strict guidelines so
that the same amount of active ingredient is delivered to the body of the same time,
and used by the body in the same way as the brand name product.
3. FDA approved : The FDA sets stringent guidelines and performs research on generic
drugs to make sure that they are bio-equivalent to the brand name.
4. Heart healthy : According to the recent study generic heart medicines show the same
medical results as brand name medicines.
5. Safety and quality: All generics are reliable since active ingredients containing spent
10 years or more at the market.

Disadvantages

1. Availability: No availability even of all generics medications popular brands.

2. Different recipients: That is, the additional ingredients that help active function
effectively.
3. Contamination: Generics are often produced in factories in countries like India,
China, or other areas with cheap labour and overhead. The conditions at these
 factories have sometimes contaminated drugs, leading to recalls in the United States.
To be fair however there have been a handful of cases where even US based brand
name medications had similar issues although probably not nearly as often.
4. Oversights : According to a report by the Government accountability office, these
foreign factories sometimes escape rigorous FDA inspections, dodge documentation
of their practices and don’t receive follow up monitoring even when serious
manufacturing or drug-handling problems have been identified. Usually only one
manufacturer produces a brand name drug whereas several manufacturers can produce
a generic drug. While the FDA insists on bio-equivalence of the active drug, there
sometimes can be subtle differences in the delivery system of the drug or the non
active “fillers” for the drug. These differences rarely result in any clinically
meaningful problem for the patient although in rare cases a patient might have a
sensitivity or intolerance to a different filler or delivery system.
5. Mixing up the pills : As brand medicines typically have a consistent “branded” look
to them that patients can get familiar and comfortable with, generics often do not look
familiar or it is not as obvious what each pill is. Furthermore when a prescription is
refilled if the medication is made by a different generic manufacturer and has a
different appearance, this can lead to medication confusion and errors or even patients
not taking the pills they are prescribed.
6. Doctors remain divided: Many medical professionals are still divided on the use of
generic drugs for heart disease, leaving some lingering doubt in this area. Some
specific medications including thyroid supplements and blood thinners have had
evidence of true clinically meaningful problems when switching between brand and
generic or between different generics.

Developments such as these make society progresses for the purpose of creating generic
medications cause a well both the consumer and the producer. This opens the availability of
drugs, fir a variety of the consumers: those with economic facilities that can defray brand
names drugs and those without economic facilities seeking equivalents of the medicines that
they need.10

10
The weeklydose.blogspot.com
 TYPES

The generic drugs are basically classified in two categories:

PSEUDO-GENERIC MEDICINES: It is not the remake of the original; it is an exact

replica of the original. It is made by the same company with exactly the same ingredients in
the same way. The only difference is the name and packaging.

These medicines are usually marked by the same manufacturer at the same price s the
original. Pharmaceutical companies make pseudo generic products to combat true generics
and to discourage competitor pharmaceutical companies from entering the market for that
particular medicine.

FILLERS, BINDERS AND LUBRICANTS: The inactive ingredients in a medicine can

include substances such as lactose, dyes and gluten. For the majority of people making
changes to these ingredients does not change the effectiveness or safety of the medicine. The
difference in formulation and production will, however change the appearance of the
medicine, for example: the shape, colour, taste or texture. Changing the appearance of a
medicine does not change its effect it has on body, although it may affect with ease with
which a person takes the medicine.

Differences between generic drugs and branded medicines are important for people who have
allergies and intolerances to some of the inactive ingredients used to make the medicine.
Therefore it is very important to discuss any allergies you may have with your doctor and
pharmacist before you take any medication and before you switch from using a brand name-
medicine to a generic medicine or vice-versa.
WHAT ARE BRANDED MEDICINES?

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 and distribute the medicine for a period of time.

WHY TO CHOOSE THE BRANDED MEDICINE RATHER THAN THE GENERIC

MEDICINE?

For many people substituting a generic copy for a brand name medicine is safe. However you
should not substitute the brand of medication you are taking if any of the following situations
apply to you:

1. You do not understand the change and feel anxious.

2. Your doctor specifically tells you that substitution for our condition is associated with
risks;
3. You are allergic or intolerant to an ingredients in the substitute;
4. You have dementia, a mental illness or are taking multiple medications and are likely
to get mixed up if a new medicine replaces one of them.
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