FARMAKOLOGI

Ditujukan Untuk Memenuhi Tugas Mata Kuliah Farmakologi

“Penggunaan Obat Generic di Kalangan Masyarakat”

Tingkat I-B

Dosen Pembimbing:

Nhadira Nhestricia, S.Farm., MKM., Apt.

Disusun Oleh:

Siti sabrina amalia 17320317057

Mita azani yulianti 17320317065

Grace yohana 17320317074

Aisyah 17320317075

Siti Nurmala 17320317080

POLITEKNIK KESEHATAN KEMENKES BANDUNG

PROGRAM STUDI KEPERAWATAN BOGOR

TAHUN AKADEMIK 2017/2018

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A. Pendahuluan
Obat generik adalah obat yang diproduksi dan didistribusikan tanpa
perlindungan paten. Obat generik mungkin masih memiliki paten pada
formulasi tapi tidak pada bahan aktif. Obat generik harus mengandung
bahan aktif yang sama dengan formulasi aslinya. Menurut US Food and
Drug Administration (FDA), obat generik identik atau dalam kisaran
bioekivalen yang dapat diterima dengan nama merek sehubungan dengan
sifat farmakokinetik dan farmakodinamik. Dengan perluasan, oleh karena
itu, obat generik dianggap (oleh FDA) identik dalam dosis, kekuatan, rute
pemberian, keamanan, khasiat dan penggunaan yang diinginkan. Saat ini
banyak produk perawatan kesehatan telah terbukti secara mencolok oleh
beberapa industri farmasi di India.
Kini industri farmasi fokus pada penelitian entitas kimia baru dan
produk dan pengembangan produk generik, karena meningkatnya
permintaan pasar ekspor dan persaingan untuk bertahan di pasar India dan
asing. Karena semakin banyak paten berakhir, penjualan bagian generik
pasar farmasi diperkirakan akan meningkat dari hari ke hari.

A. Rumusan Masalah
Bagaimana penggunaan obat generik di kalangan masyarakat?
B. Tujuan Penulisan
Mengetahui penggunaan obat generik di kalangan masyarakat.
C. Metode Penulisan
Dalam pembuatan makalah ini kami menggunakan referensi dari jurnal
internasional yang dipublikasikan 25 January 2011 yang berjudul “Generic
Drugs-A Ground Discussion”.

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D. Diskusi dan Pembahasan
Obat generik didistribusikan tanpa perlindungan paten
maksudnya yaitu obat ini dapat diproduksi oleh siapapun karena tidak
ada hak patennya. Jadi, semua orang bisa memproduksi asalkan
dengan merek berbeda.
Terdapat beberapa mitos tentang obat generik
diantaranya,masyarakat kurang mempercayai obat generik, ketika
mereka mengkonsumsi obat tersebut ternyata merek, warna,
penampilan dan bentuknya yang berbeda. Selain itu, mereka juga
memiliki pola pikir bahwa “Lebih Mahal Akan Lebih Efektif”. Mereka
berpikir pasti ada yang salah dengan obatnya karena terlalu murah.
Ada beberapa yang menjadi alasan utama harga obat
generik yang relatif rendah yaitu persaingan antar produsen saat
narkoba tidak lagi dilindungi paten. Perusahaan mengeluarkan biaya
sedikit dalam menciptakan obat generik, produsen tidak menanggung
biaya penemuan obat dan sebaliknya dapat merekayasa balik senyawa
obat yang dikenal memungkinkan mereka membuat versi bioekivalen
dan juga tidak menanggung beban,membuktikan keamanan dan
kemanjuran obat melalui uji klinis.
Dari ulasan diatas USA FDA ( Food and Drug
Administration) mengeluarkan peraturan untuk obat generik yaitu
Abbreviated New Drug Application (ANDA) berisi data yang ketika
diserahkan ke pusat evaluasi Center for Drug Evaluation and Research
(CDER), kantor obat generik memberikan ulasan dan pesetujuan akhir
dari produk obat generik. Setelah disetujui, pemohon dapat
memproduksi dan memasarkan produk obat generik untuk
memberikan alternatif biaya rendah yang aman dan efektif yang
produknya sebanding dengan obat paten dalam sediaan, kualitas dan
lai-lain. Semua produk yang disetujui baik paten atau generik harus
tercantum dalam produk obat disetuji FDA. Pelamar generik harus

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menunjukkan secara ilmiah bahwa produk mereka bersifat bioekivalen
(kecepatan zat aktif dalam produk). Versi generik harus memberikan
jumlah bahan aktif yang sama ke aliran darah pasien dalam jumlah
waktu yang sama dengan obat paten.
Saat ini produk kesehatan sangat diminati oleh banyak
industri farmasi di India. Kini industri farmasi berfokus pada penelitian
dengan wujud kimia baru, produk dan pengembangan produk generik.
Karena meningkatnya pasar ekspor dan untuk bertahan hidup,
penelitian dilakukan sebagian terhadap agen kardiovaskuler,agen
sistem saraf pusat, agen anti diabetes dan sebagainya. Perusahaan India
lebih fokus pada obat generik untuk menentukan standar mereka agar
setara dengan pasar obat generik dari negara maju. India adalah pilihan
terbaik bagi banyak perusahaan multinasional untuk membuat
manufaktur dan mengeluarkan uang secara maksimal dibidang
penelitian. Karena semakin banyak paten berakhir, penjualan produk
generik pasar farmasi India diperkirakan akan meningkat dari hari ke
hari, tetapi harus disetujui FDA dengan persyaratan data versi generik
obat itu bioekivalen harus dikirim untuk pemeriksaan FDA, rumus
bahan aktif dan tidak aktif oleh produsen harus diserahkan kepada
FDA sebelum obat tersebut dipasarkan, tanpa produsen persetujuan
FDA tidak dapat perubahan besar dalam formulasi, uji evaluasi produk
obat generik oleh produsen harus dikirim kepersetujuan FDA,
pelebelan obat oleh produsen diserahkan untuk ulasan FDA, obat yang
sudah disetujui telah dipantau oleh FDR untuk kualitasnya, reaksi
merugikan dan efek kesehatan serius yang diamati oleh produsen harus
dilaporkan ke FDA, pabrik manufaktur harus diperiksa oleh FDA
secara berkala dan ketaatan pabrik terhadap praktek manufaktur yang
baik harus dievaluasi oleh FDA sebelum obat dipasarkan. Berikut ini
adalah pencegahan saat menggunakan produk generik yaitu konsultasi
komplikasi dengan dokter, hindari penggunaan produk kadaluarsa,
jauhkan mereka dari jangkauan anak-anak, ikuti resep dokter, baca

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 semua intruksi dalam produk dengan seksama, simpan sesuai intruksi
didalam produk dan beli mereka dari toko obat resmi.
Selanjutnya keunggulan obat generik ketika obat paten
kadaluarsa,perusahaan farmasi dapat mulai memproduksi versi generik
obat-obatan. Manfaat terbesar yang diberikan obat generik adalah
keuntungan ekonomi. Selain itu konsumen bisa menghemat uang, obat
generik juga membuat obat-obatan yang dibutuhkan tersedia secara
luas untuk populasi yang sebelumnya tidak mampu membelinya.
Dari keunggulan obat generik terdapat juga kekurangan dari
obat tersebut umumnya obat generik mungkin menjadi parasit ekonomi
perusahaan yang patennya kadaluarsa, selama studi bioekivalen
beberapa kesalahan mungkin timbul yang dapat menyebabkan
komplikasi, studi bioekivalen kurang akurat dan beberapa pasien
mungkin alergi terhadap warna baru, rasa dan sebagainya.

E. Hasil dan Kesimpulan

Dari hasil diskusi yang telah kami dilakukan, didapatkan hasil dan
kesimpulan yaitu:
Biaya perawatan kesehatan terus meningkat. Oleh karena itu,
konsumen, penyedia dan pembuat kebijakan perlu menilai cara terbaik
untuk menjaga agar pelayanan kesehatan tetap terjangkau. Tanpa
mempengaruhi akses terhadap perawatan berkualitas, dengan biaya obat
resep (obat bermerek) berperan sebagai penyumbang utama kenaikan
biaya, obat generik menawarkan alat penting untuk mengurangi tingkat
pertumbuhan dalam pengeluaran kesehatan secara keseluruhan. Karena
semakin banyak paten berakhir, porsi generik pasar farmasi diperkirakan
berlanjut untuk peningkatan penjualan. Sementara obat nama merek pasti
memainkan peran penting dalam pengobatan, obat generik adalah
alternatif biaya yang efektif. Biaya farmasi meningkat lebih cepat daripada
bagian lain dari biaya perawatan kesehatan. Tidak hanya biaya obat
generik yang efektif, tapi juga aman.

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 Obat generik bersifat bioekuivalen dengan nama merek kembar
mereka. Sebagai obat generik cenderung lebih tua, mereka umumnya
kurang berisiko dibandingkan terapi obat baru. Obat generik menawarkan
pilihan pengobatan yang tepat untuk pasien. Jadi pasien harus diberi tahu
tentang obat generik dan mitos harus dipecahkan bahwa "lebih mahal akan
efektif." Jika semua hal ini berjalan seiring, obat generik dapat membuat
biaya medis menjadi murah dan melegakan bagi orang-orang yang tinggal
di negara-negara yang terkena dampak ekonomi.

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 LAMPIRAN

Generic Drugs-A Ground Discussion

Khullar Rachit*, Goel Arvind, Aggarwal Geeta

Rayat Institute of Pharmacy, Railmajra, District Nawanshahar, Punjab.

Corresponding Author: Khullar Rachit, Rayat Institute of Pharmacy, Railmajra, District Nawanshahar, Punjab, E-
mail:rachit_pharmacy@yahoo.co.in

Received: 23 October 2010 Accepted: 25 January 2011

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Citation: Khullar Rachit, Goel Arvind, Aggarwal Geeta,"?Generic Drugs-A ground Discussion",Int. J. Drug Dev. & Res., Jan-March 2011, 3(1):
178-184. doi: doi number

Copyright: © 2010 IJDDR, Khullar Rachit et al. This is an open access paper distributed under the copyright agreement with Serials
Publication, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Related article at Pubmed, Scholar Google

Visit for more related articles at International Journal of Drug Development and Research

Abstract
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. 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 within an acceptable bioequivalent range to the brand name
counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by FDA)

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identical in dose, strength, route of administration, safety, efficacy and intended use. At present many health care products have been
prominently provided by several pharmaceutical industries in India. Now the pharmaceutical industry is focusing on research of new
chemical entities and products and development of generic products, because of the increased export market demands and competition
for survival in Indian and foreign market. As more and more patents expire, sales of the generic portion of the pharmaceutical market are
expected to increase day by day. The aim of this article is to access the usage of generic drugs

Key words

Generic drugs, FDA regulations of generics, Pharmaceutical Industry

Introduction

A generic drug (generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent

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on the formulation but not on the active ingredient. 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 within an acceptable bioequivalent range to the
brand name counterpart with respect to pharmacokinetic and pharmacodynamic propertie s. By extension, therefore, generics are
considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy and intended use. In most cases, generic
products are available once the patent protections afforded to the original developer have expired. When generic products become
available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms.
The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are
applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.1

MYTHS ABOUT GENRIC DRUGS

? Misbranded drugs: Generally people think that generic drugs are misbranded because of change in the color, taste, appearance than
original (ethical drug). But alterations of the color, taste, appearance is the part of the generic formulations and they are not misbranded.

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? Duplicate drugs: Due to their change is the brand name or shape of the of dosage shape packing, some may think the drugs are duplicate.

? Rejected drugs and fake drugs: Due to cheap price of the generic drugs, it is generally thought that generic drugs are rejected form the
company that is why they are selling for the low price.

? Drugs manufactured at third party manufacturing unit: This myth is in the mind of the wholesaler or the retailer that the drugs which are
manufactured at some other plant which is not company’s own plant. Generally this true because generic drugs are generally
manufactured at small scale industry but it is not applicable in all the cases.

? Ineffective drugs: People also have a mindset that “costlier will be effective”. They think that there is surely something wrong with the
medicine because it is too cheap.2-4

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WHY GENERIC DRUGS ARE INTRODUCED

The principal reason for the relatively low price of generic medicines is

? 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. The costs of these generic drugs are so low that
many developing countries can easily afford them.

? Generic manufacturers do not incur the cost of drug discovery and instead are able to reverseengineer known drug compounds to allow
them to manufacture bioequivalent versions.

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? Generic 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.

? A brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at
a level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company
to make a significant profit on their investment in research and development, thus enabling them to fund the research and development of
new medicines which most generic companies doesn’t undergo all these things.

? Introduction of competition, which prevents any single company from dictating the overall market price of the drug. Competition is also
seen between generic and name-brand drugs with similar therapeutic uses when physicians or health plans adopt policies of preferentially
prescribing generic drugs as in step therapy.

? Multiple firms producing the generic version of a drug the profit-maximizing price generally falls to the ongoing cost of producing the
drug, which is usually much lower than the monopoly price.5

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PROCESS OF INTRODUCTION OF GENERIC DRUGS

Most nations require generic drug manufacturers to prove that their formulation exhibits bioequivalence to the innovator product. The
FDA must approve generic drugs just as innovator drugs must be approved. The FDA requires the bioequivalence of the generic product to
be between 80% and 125% of that of the innovator product.

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Milestones in generic drug development

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This value range is part of a statistical calculation and does not mean that FDA lets generic drugs differ from the brand name counterpart
by up to 25 percent. These studies compare the absorption of brand name and generic drugs into a person’s body. These studies are
submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand
name are 3.5 percent and comparable to differences between two different batches of a brand drug.

FDA REGULATIONS FOR GENERIC DRUGS

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research
(CDER), Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may
manufacture and market the generic drug product to provide a safe, effective, low cost alternative. A generic drug product is one that is
comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and
intended use. All approved products, both innovator and generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations (Orange Book.) Generic drug applications are termed "abbreviated" because they are generally not required to include
preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically
demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate
bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them

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the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic
version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.
Guidance documents to help to prepare ANDAs are listed together on CDER’s Guidance Document Index web page in the following
categories:

Generics:

? Generics (Draft - Distributed for comment purposes only).

? Procedural Draft: This provision permits FDA to rely, for approval of an NDA, on data not developed by the applicant.

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Biopharmaceutics:

? Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. This guidance should be useful
for applicants planning to conduct bioavailability (BA) and bioequivalence (BE) studies during the IND period for an NDA, BE studies
intended for submission in an ANDA and BE studies conducted in the post-approval period for certain changes in both NDAs and ANDAs.

Drug master files:

? A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities,
processes, or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.

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? Required Specifications for FDA’s IND, NDA and ANDA Drug Master File Binders

Guidance for industry:

? Changes to an Approved NDA or ANDA

Refusal to receive:

? Clarifies CDER’s decisions to refuse to receive an incomplete application.

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Inactive ingredient database:

? This database contains all inactive ingredients present in approved drug products or conditionally approved drug products currently
marketed for human use.6-7

PHARMACEUTICAL INDUSTRY AND GENERIC PRODUCTS

The health care products at present have been prominently provided by many pharmaceutical industries in India. Now the pharmaceutical
industry is focusing on research of new chemical entities and products and development of generic products, because of the increased
export market demands and competition for survival in indian and foreign market. Mostly the research has been going on cardiovascular
agents, central nervous system, antidiabetic agents, anti-cancer agents, anti-HIV agents etc. The indian companies have better option to
focus more on generic drugs to raise their standards equivalent to the generic drug markets of the developed countries. Because of best

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chemistry skills and low cost advantages, India is the best option for many MNCs to set up manufacturing and to spend more money in the
field of research. As more and more patents expire, sales of the generic portion of the Indian pharmaceutical market are expected to
increase day by day. But prior to sale of generic products, it should be approved by FDA, which includes following requirements:

? The data of generic versions of a drug which shows the drug is bioequivalent to the one used in the original safety and efficacy testing
must be sent for FDA review.

? The formula of active and inactive ingredients used by manufacturer must be submitted for FDA review before the drug has to be
marketed.

? Without FDA approval manufacturer could not do any major changes in formulation.

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? The evaluation tests of generic drug product performed by the manufacturer should be sent to FDA approval.

? The drug labelling carried out by the manufacturer must be submitted for FDA reviews.

? The drug which is already approved has been monitored by FDA for its quality.

? The adverse reactions and serious health effects observed by the manufacturer must be reported to FDA.

? The manufacturing plants must be inspected by FDA periodically.

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? The manufacturer‘s adherence to good manufacturing practices must be evaluated by FDA before the drug is marketed.8-10

PRECAUTIONS WHILE USING GENERIC PRODUCTS:

? Consultation of complication with the doctor

? Avoid the use of expiry date products

? Keep them away from the reach of children

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? Strictly follow the doctor’s prescription

? Read all the instruction given on the product carefully

? Store them according to the instruction given on the product

? Purchase them from the authorized medical shop. 11-14

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ADVANTAGES OF GENERIC DRUGS

When a drug patent expires, other pharmaceutical companies can begin producing generic versions of the drugs. These products provide
many economic advantages to consumers in both developed and developing countries, insurance companies, other pharmaceutical
businesses and public health. The biggest benefit that generic drugs provide is economic benefits. Most of the cost of any new drug lies in
the research and development of the product. A generic drug allows a company to reverse-engineer an existing product and manufactures
it under a nontrademarked name. Figure 1 shows the comparison of prices (10 tablets) of branded drugs versus generic drugs.

? In addition to saving consumers money, generic brand drugs also make needed medicines widely available to populations that could not
previously afford them.

? Generic drugs are just as safe as the trademarked "name brand" drugs for which they substitute. The FDA requires any generic drug to
undergo clinical trials, both to prove safety and efficacy. Also, generic drugs must provide patients with "bio equivalent" results to the
name-brand product they replace, meaning that the generic drug must achieve the same results as the drug it copies (within a certain

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range of statistical tolerance).15-18

DRAWBACKS OF GENERIC DRUGS

Drawbacks of generic drugs are much smaller than its advantages.

? Generally generic drugs may parasite the economy of the company whose patent got expired or whose molecule or formulation was
unique.

? During bioequivalence studies, some error may arise which may lead to some complications. More over bioequivalence studies are less
accurate than bioavailability studies.

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? There may be some variations during reformulations

? Some patients may be allergic to new colours, flavours etc.

? Generic drugs are not possible in all the cases. Because it takes long time to expire any patent.19

CONCLUSION: WHY WE SHOULD USE GENERIC DRUGS???

Health care costs continue to rise. Therefore, consumers, providers and policymakers need to assess the best way to keep health care

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affordable. Without adversely affecting access to quality care, with prescription drug (branded drug) costs serving as a major contributor to
cost escalations, generic drugs offer an important tool for reducing the rate of growth in overall health expenditure. As more and more
patents expire, the generic portion of the pharmaceutical market is expected to continue for increased sales. While brand name drugs
certainly play an important role in medicine, generic drugs are a cost effective alternative. Pharmaceutical costs are increasing faster than
any other portion of the health care expense. Not only are generic drugs cost effective, but they are safe. Generic drugs are bioequivalent
to their brand name twins. As generics tend to be older, they are generally less risky than new drug therapies. Generic drugs offer sound
treatment options for patients. So patients should be told about the generic drugs and myths should be solved that “costlier will be
effective.” If all these things go hand in hand generic drugs may make the medical costs cheap and a relief for the people living in economic
struck nations.

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 DAFTAR PUSTAKA

http://www.ijddr.in/drug-development/generic-drugsa-ground-
discussion.php?aid=5544

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