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Generic Medicine and Prescribing: A Quick Assessment

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Review Article

Generic Medicine and Prescribing: A Quick Assessment


Mainul Haque
Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur,
Malaysia

Abstract
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
counterparts. The Food and Drug Administration (FDA) describes that generic drugs are essential possibilities that allow better access to
healthcare for all Americans. They are replicas of brand‑name drugs and are the identical as those of brand‑name drugs in dosage form, safety,
strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that
FDA‑approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in
court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array
of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court’s ruling will prevent companies from further seeking
unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so
it is regularly a low‑priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the
Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names,
has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing,
it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and
adopt policy measures to address the issues identified.’

Keywords: Generic, medicine, prescribing

A Brief Description about Generic Medicine performance features, and anticipated to use. Healthcare
authorities and users can be guaranteed that FDA‑approved
‘Generic drugs are copies of brand‑name drugs that have
generic drug products have met the same stiff principles as
exactly the same dosage, intended use, effects, side effects, the innovator drugs. All generic drugs permitted by the FDA
route of administration, risks, safety, and strength as the have the same high quality, strength, purity, and stability as
original drug. In other words, their pharmacological effects are brand‑name drugs. The generic manufacturing, packaging, and
exactly the same as those of their brand‑name counterparts’.[1] testing sites must pass the same quality standards as those of
The Food and Drug Administration (FDA) of the USA requires brand name drugs.[4]
generic drugs to have the same quality and performance as
brand‑name drugs. Generic drugs are required to have the
same active ingredient, strength, dosage form, and route of
Generic Medicine and Court Verdicts
administration as the brand name product.[2] The FDA requires The company that made Bayer aspirin fought in court
that all drugs should be safe and effective. Since generics use enthusiastically to keep generic versions off the shelves, in the
the same active ingredients and are shown to work the same 1920s. ‘The company lost in court, and consumers suddenly
way in the body, they have the same risks and benefits as their had an array of choices in generic aspirin’.[5] ‘The Supreme
brand‑name counterparts.[3] The FDA describes that generic
Address for correspondence: Prof. Mainul Haque,
drugs are essential possibilities that allow better access to Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti
healthcare for all Americans. They are replicas of brand‑name Pertahanan Nasional Malaysia (National Defence University of Malaysia),
drugs and are the identical as those brand‑name drugs in Kem Sungai Besi, 57000 Kuala Lumpur, Malaysia.
E‑mail: runurono@gmail.com
dosage form, safety, strength, route of administration, quality,

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DOI:
10.4103/AIHB.AIHB_26_17 How to cite this article: Haque M. Generic medicine and prescribing: A
quick assessment. Adv Hum Biol 2017;7:101-8.

© 2017 Advances in Human Biology | Published by Wolters Kluwer - Medknow 101


Haque: Generic medicine

Court ruled on Monday that generic drug manufacturers could medicine is that it saves as high 90% over the cost of brand
not be sued by patients who claim that drugs they took were medicine. Generics on an average save 40%–60% than
defectively designed. The decision is a significant victory for proprietary medicine. That is a real plus point especially for
the generic drug industry, but further narrows the recourse for geriatric population on a fixed income who take numerous
people who are injured by such drugs’.[6] The Indian Supreme medications.[12] In a systematic meta‑analysis which includes
Court supported a portion of India’s patent law critical to 47 studies (38 of 47 were randomised controlled trials) covering
conserving the nation’s generic drug industry when it ruled that nine subclasses of cardiovascular medications (beta‑blockers,
the Swiss pharmaceutical company Novartis should not receive diuretics, calcium channel blockers, antiplatelet agents, statins,
a patent for its leukemia drug Gleevec®. This verdict was angiotensin‑converting enzyme inhibitors, and alpha‑blockers),
being supported by one consumer group and congratulate the no evidence of superiority regarding efficacy and safety of
Supreme Court of India uttering ‘the Supreme Court’s ruling brand‑name drugs versus generics was found. Even with those
will prevent companies from further seeking unwarranted having narrow therapeutic index drugs such as antiarrhythmic
patents on HIV and other essential medicines’.[7] The U.S. agents and warfarin show 100% clinical equivalence.[13]
Supreme Court has refused to re‑assess a case that emphasised Many people in both developing and developed countries
the combative concern of ‘product labelling and the extent apprehend that generic medicines are somehow inferior in
to which generic drug makers are able to independently and quality, but essentially this is not true. Unlike generics, any
quickly act to provide consumers with risk information’.[8] other products, such as cereal, soap, or canned goods, where
the brand is indeed claimed better, are not applicable for
generics. As generic medicines are exactly same molecule
Advantages of Generic Medicine and produced following the identical procedures like that of
Costlier propitiatory medicines can now and again upset branded-proprietary medicine. Thereafter, generic medicines
people’s financial capability to rigorously stick to the dosage obtain approval from the FDA, or any other drug regulatory
schedule prescribed by the doctor, especially when there are authority rules require generic drugs to have the same active
many repeats and the medicine has to be procured on multiple chemicals as the original brands.[14]
times. The foremost benefit of generic medicine use is the
cost‑efficacy benefit. Generic medicine cannot be sold at a
price higher than the branded medicine, so it is regularly a
Generic Medicine and Low‑income Countries
low‑priced option. Thereafter, both for the end user and the Medicines account for 20%–60% of global health expenses,
government who pay for part of the price of the medicine under somewhat more in low‑ and middle‑income countries, and
the Pharmaceutical Benefits Scheme in Australia are benefitted. therefore, constitute a most important part of the budget[15,16]
Hence, patients can adhere their medications as prescribed and 18% in countries of the Organization for Economic
by the doctor.[9] As soon as a pharmaceutical industry designs Co‑operation and Development.[16] Up to 90% of the people in
and develops a new drug, it gains a patent for that drug. The developing countries consume medicines through out‑of‑pocket
patent safeguards the developer’s investment in developing payments,[17] making medicines the major family‑spending
the drug, and no one else can lawfully vend the meticulously item after food. Thus, medicines are unaffordable for large
same drug for a period up to 17 years. That patent‑protected sections of the global population and are a major burden
drug is the innovator drug. Therefore, when patients, hospitals, on government budgets.[16] The Trade‑Related Aspects of
communities, or government purchase that particular medicine Intellectual Property Rights (TRIPS) agreement, completed
actually paying for the ‘research costs, the costs incurred in in 1994, transformed global patent law by necessitating the
proving it is safe, the costs to market and transport the drug, standardisation of intellectual property law among all WTO
and a premium if it is the only available drug for a certain member countries by early 2005. Instantaneously, there raises
apprehension that the TRIPS agreement would minimize public
symptom, disease or condition’.[10] Those costs can patent
health facilities in low‑ and middle‑income countries.[18] TRIPS
drugs very expensive to purchase by patients or government
threats to the supply of generic antiretroviral medicines from
at many occasion. The industry thinks that the price is the
‘India are coming at a time when the prospects of antiretroviral
way to recover its development overhead expenditures. The
therapy scale up are already cloudy’.[19] Thereafter, the
moment that patent‑protected time has expired, any other
provision of generic medicine is one of the best operational
company can produce and market that drug with the same
means of bringing lifesaving therapeutics and vaccines to
ingredients as the branded one. Nonetheless, the FDA ensures
the low‑income countries and marginalised communities
that the product will be exactly ‘identical, or bioequivalent,
throughout world (Editorial).[20]
to a brand‑name drug in dosage form, safety, strength, route
of administration, quality, performance, characteristics, and
intended use’[11] and also asserts that a generic drug must Generic Medicine Promotes Rational Prescribing
be given a new name. Since the company that manufactures The treatment of diseases using essential drugs, prescribed
the generics did not incur the costs of the original research, by their generic names, has been emphasised by the WHO
testing, or marketing, the cost is lower’.[10] Another study and the National Health Policy of India.[21,22] Code of Ethics
reported that the principal advantage of low cost of generic Regulations 1.5, 2002 of Medical Council of India describes

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Haque: Generic medicine

the uses of generic names of drugs: ‘Every physician should, Institute of Medical Sciences Islamabad, Rawalpindi General
as far as possible, prescribe drugs with generic names and Hospital and Military Hospital of Rawalpindi, found quite
he/she shall ensure that there is a rational prescription and low (23.6%) but 80% of medicines prescribed were from the
use of drugs’.[23] Therefore, to promote rational prescribing, National EDL Drug List of Pakistan.[38] Although there were
it has been resolutely advocated to use the generic name, for improvement regarding generic prescribing and utilization of
example, omeprazole instead of zegerid. Thereafter, prescriber EDL but the country need lot more to do to improve rational
does not express any inclination towards any particular prescribing and to ensure better health care.
proprietary brand of the drug.[24] Against the background
of such strong law, the actual scenario was something very Physician Perception Regarding Generic
deplorable. It was found that the prescription of generic drugs
ranged from 3% to 20%.[25] Another study conducted in Delhi, Medicines
India, found generic prescribing in outpatient department to Largely, the mainstream of physicians is comfortable with
be 6.32%–25.14% which was quite similar with an earlier the efficacy of generic medications and is satisfied in using
study.[26] After few years, one more additional study in a generics. Nonetheless, there are significant fractions of
major teaching tertiary‑level public hospital found that there physicians’ expresses their apprehensions about the efficacy and
was quite higher  (73.4%) generic prescribing.[27] The drug quality generics, and especially senior physicians have definite
prescribed by generic name was 48.5% in overall situation in trepidations.[39] A systematic review analyzing 52 articles revealed
Madhya Pradesh, India. Medicines prescribed by generic name that a noteworthy number of doctors were concerned about the
in primary health centres (PHCs) were higher as compared to efficacy, safety, and quality of generic medicines. Moreover,
civil dispensaries (CDs) which were statistically significantly doctors believe that generic medicine causes more adverse
higher (P < 0.001). The drugs prescribed from Essential Drug effects. The negative perceptions of specially among doctors and
List (EDL) of Madhya Pradesh (India) were 66.9%. Yet again, pharmacists are the principal obstacles for wider acceptance of
PHCs were prescribing is statistically significantly (P < 0.001) generic medicines both in individual and community level.[40]
higher in number from EDL as compared to CDs.[28] One recent Greek study reported that the national initiative for
generic prescribing has been poorly endorsed by the physicians
One multicentre study in eight cities of South and Midwest of the country.[41] Nevertheless, Jordanian physicians have a
of Brazil reported that most drugs (86.1%) were prescribed positive attitude in the direction of generic medications and highly
by generic name.[29] Nonetheless, irrespective of the level motivated to prescribe generic medicines.[42]
of healthcare delivery system, prescribing drugs by generic
name reduces duplicity, improves access to medicines, and
subsequently, escalates patient compliance with drug therapy Medical Students’ Perception Regarding Generic
and disease control. It is expected that emphasizing to medical Medicines
students about generic medicines will improve and promote Although other aspects of generic medicines knowledge
rational prescribing.[29] The percentage of generic prescribing level were found good, there was a significant knowledge
was 100% in all four hospitals of United Arab Emirates as gap about the regulatory bioequivalence limits for generic
recommended by the WHO. The success of generic prescribing medicines.[43] Medical and pharmacy students of Bangladesh
was because of electronic prescribing systems in healthcare possess a moderate knowledge level of generic medicines.
services.[30] One Cambodian study conducted in three health Moreover, it has been found that pharmacy students were
centres reported that prescribing by generic names was 99.8%. more inclined about generic medicines than that of medical
It was really encouraging against the background of reducing students. The study finally recommended that Bangladeshi
the irrational use of drugs at the health centre level which medical educational authorities should take abrupt action to
remains a major challenge.[31] Although many other issues of transform curricula to safeguard better understanding of future
rational prescribing and healthcare still exist in Cambodia, medical practitioners about the use of generic medicine.[44]
the percentage of drugs prescribed by generic name and Another Afghan study reported that medical students need
from an essential drug list in Hawassa University Teaching more accentuates to improve awareness and knowledge
and Referral Hospital of Ethiopia was 98.7%  (n = 2419) about generic medicines. There is an urgent need to progress
and 96.6%  (n  =  2367), respectively.[32] Although, earlier regarding the knowledge level of the quality, prices, and
study findings were 75.2% and 87% in Jimma Hospital and safety of generic medicines including cost‑efficacy.[45] Another
National baseline study of Ethiopia, respectively.[33,34] Generic study from Iraq clearly shows that medical students in Iraq
prescribing was found to be 49.3% in Nigerian army hospitals.[35] are deficient related to generic medicine use. The study
In another Nigerian study in a tertiary care teaching hospital, thereafter suggested that incorporation of generic medicine
generic prescribing was found similarly low at 42.7%.[36] The use in curriculum may improve and promote the use of generic
drugs prescribed by generic name was 64.12%, and from the medicines and prescribing.[46] The principal result of one study
National Essential Drug List was 67.70% in village health from the USA was that only 24% of study participants possess
clinics across ten provinces of western China.[37] Prescribing proper knowledge of generic medicines. Therefore, promoting
generic names in three public hospitals, namely, Pakistan the use of generic medicines and prescribing is imperative to

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Haque: Generic medicine

minimize healthcare costs.[47] The overall perception of medical past 30 years, the model list has led to a global acceptance of the
students regarding generic medicines is not up to the mark to concept of essential medicines as a powerful means to promote
promote generic prescribing. Therefore, there is an urgent need health equity. Most countries have national lists and some
to enhance medical students’ knowledge and attitude in their have provincial or state lists as well. National lists of essential
teaching–learning sessions of clinical pharmacology regarding medicines usually relate closely to national guidelines for
generic medicines and promoting generic prescribing. Hence, clinical healthcare practice which are used for the training and
community or country can minimize healthcare costs and also supervision of health workers’.[62] ‘The WHO Model Lists of
ensure rational prescribing. Essential Medicines has been updated every 2 years since 1977.
The current versions are the 19th WHO Essential Medicines List
Generic Medicines and Neglected Diseases and the 5th WHO Essential Medicines List for Children updated
in April 2015’.[63] ‘In 1977, nearly a dozen countries had what
A lot of diseases conquer because drugs are old and
would now be considered an essential medicines list or an
ineffective, or merely do not exist. Every year, 1 billion
essential drugs program. Today, four out of five countries – at
people globally are affected by neglected diseases, such as
malaria, tuberculosis (TB), leishmaniasis, and lymphatic least 156 countries in total – have adopted national essential
filariasis, which impose tremendous public health burdens.[48] medicine lists. Thirty years ago, the concept of a national
TB is a major killer in poor countries, but no new anti‑TB drug policy was unknown to most countries. Today, over 100
drug has been developed since the 1960s.[49] There are rare, countries have such policies in place or under development. In
often life‑threatening diseases, defined in Europe as affecting 1977, objective information on the rational use of medicines was
fewer than one in 2000 people, for which more ‘orphan drugs’ extremely limited, especially in developing countries. Today,
need to be developed.[50,51] There are diseases that are highly at least 135 countries have their own therapeutic manuals and
prevalent, such as HIV/AIDS in South Africa, but while formularies, which provide health professionals with up‑to‑date,
new, effective medicines exist, millions of people and their accurate, and unbiased advice on the rational use of drugs.
governments cannot afford them or they are not available at When the first Essential Medicines List appeared, the WHO
all.[52,53] Neglected tropical diseases, such as malaria, affect Programme for International Drug Monitoring was just being
millions of people, but most are too poor to constitute a market formally established. Today, a network of 83 countries provide
that is profitable enough in the private market to develop global monitoring for adverse drug reactions and regularly
new treatments.[54,55] Since the 1970s, some pharmaceutical pick up signals on potential safety problems. Thirty years ago,
industries in developing countries have been unfolding new there was virtually no publicly available price information and
production procedures through reverse engineering technology few countries actively encouraged generic substitution. Today,
to produce medicines which are still under patent elsewhere in at least 33 countries have carried out availability and pricing
the world.[56] This generic production has contributed to both surveys and provide that information publicly. In addition,
industrial development and greater access to medicines through the wider use of quality‑assured generic medicines since the
lower prices.[56] These countries may not be able to continue 1990s has brought down prices through increased demand and
to produce generic medicine as because of the introduction of competition’.[64]
new stronger and stringent patent protection law.[57] Currently, The high price of medicines, predominantly in the private sector,
the principal approach for safeguarding access to medicines is additional strategic hurdle to access to inexpensive essential
for neglected diseases is drug donation from Western drug medicines in developing countries.[65] Several countries have
industries.[58] Nevertheless, this reliance upon profit‑driven made considerable improvement towards increasing access
organisations is dangerous. Undoubtedly, a more defensible to essential medicines and treatments to combat HIV/AIDS,
approach is required.[58] Public, private, and benevolent societies malaria, and TB, but access to essential medicines in developing
and groups internationally have started to work together to find countries is not sufficient. In countries for which there is
and produce new medicines to treat neglected diseases.[59‑61] information, the availability of medicines in the public sector
is only one third, while private sector availability is about
Generic Medicines and Essential Drugs two thirds, and the prices people pay for low‑priced generic
‘Essential medicines are those that satisfy the priority healthcare medicines vary from 2.5 times to 6.5 times international
needs of the population. Essential medicines are selected with reference prices in these two sectors, respectively.[65] ‘Access
due regard to disease prevalence and public health relevance, is defined as having medicines continuously available and
evidence of clinical efficacy and safety, and comparative costs affordable at public or private health facilities or medicine
and cost‑effectiveness. Essential medicines are intended to outlets that are within one hour’s walk from the homes of the
be available within the context of functioning health systems population’.[66] In the mainstream of circumstances, generically
at all times in adequate amounts, in the appropriate dosage equivalent medicines are priced substantively lower than the
forms, with assured quality, and at a price the individual and originator brand.[67] Increasing the use of quality‑assured
the community can afford. The model list is a guide for the generic medicines is, therefore, a key strategy for improving the
development of national and institutional essential medicine affordability of medicine. A range of policy options is available
lists. It was not designed as a global standard. However, for the to promote the use of generics, including allowing pharmacists

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Haque: Generic medicine

to dispense a generically equivalent product in place of the its execution in Malaysia.[74] Malaysia’s well‑established public
originator brand listed on the prescription. Such generic healthcare system is encountering new threat from increasing
substitution by pharmacists is allowed in many countries, medicine costs. The free market by definition does not control
sometimes with a requirement to inform the patient. [68] prices of any product including medicine, demanding price
Lawful provisions to permit will inspire much more generic monitoring, and control mechanisms. Markups for generic
changeover of medicine from costly branded proprietaries products are greater than for innovator brands. Reducing the
in the private sector which occurs in 86% and 100% of the base price without controlling markups maximizes profits
developed and transition economies, respectively.[69‑71] The for retailers and dispensing doctors without plummeting the
WHO suggested that to accelerate the progress of essential price paid by patients. Promotion of generic medicines, and
medicines many policy changes needed both at national improved accessibility of medicines in the public sector are
and global level needed. Those are ‘At the national level: (i) required to increase access and affordability of most essential
eliminate taxes and duties on essential medicines; (ii) update medicines for the common people of Malaysia.[75] Thereafter,
national policy on medicines; (iii) update the national list of the aims of National Medicine Policy of Malaysia[73] which
essential medicines; (iv) adopt generic substitution policies describe access to affordable and lower priced medicines for
for essential medicines; (v) seek ways to reduce trade and common people of Malaysia are not being achieved.[75]
distribution markups on prices of essential medicines; (vi)
ensure adequate availability of essential medicines in public Struggle of Bangladesh for Generic Medicines
healthcare facilities; (vii) regularly monitor medicine prices and The Bangladesh court ordered that ‘doctors must use generic
availability. At the global level: (i) encourage pharmaceutical drug names rather than specifying particular brands’.[76]
companies to apply differential pricing practices to reduce Bangladesh has built a durable baseline and self‑sufficient
prices of essential medicines in developing countries where medicine production line after the promulgation of Drug Control
generic equivalents are not available; (ii) enhance the promotion Ordinance – 1982. Such development of pharmaceutical sector
of the production of generic medicines and remove barriers to has contributed substantially to its economy and developed
uptake; (iii) increase funding for research and development in from an import‑dependent country to self‑reliant and exporting
areas of medicines relevant to developing countries, including globally. Bangladeshi pharmaceutical industries have started to
children’s dosage forms and most neglected diseases’.[65] produce vaccine, insulin, anticancer drugs, etc. Pharmaceutical
industries are quite successful in domestic market. Hence, the
Generic Medicines’ Situation in Malaysia pharmaceutical sector has already been acknowledged as the
One study conducted in Malaysia reported that practically half thrust sector by the Government of the People’s Republic of
of the respondents had negative belief in generic medicines. Bangladesh.[77‑79] In South Asia, India is the principal producer
Correspondingly, many patients were not conscious of the of generic drugs followed by Bangladesh and Sri Lanka.[80]
relationships and variances between generic and original The Bangladesh pharmaceutical industry produces about
brand medicines. Consequently, there is a need to provide 8000 generic drugs under 26,813 registered brands in different
patients with adequate information about generic medicines.[72] dosages and strengths. The Government of Bangladesh controls
Although the Government of Malaysia has definite policy the price of 209 generic drugs in specified dosage forms,
regarding generic medicines to foster healthy competition along with 41 active pharmaceutical ingredients produced in
in medicines pricing, the generic shall be ‘used to guide the the country and medicine imports. Bangladesh exports about
use and procurement of medicines as follows: (1) prescribing 500 pharmaceutical items, including active pharmaceutical
in generic International Non‑proprietary Name (INN) ingredients as well as a wide range of pharmaceutical products
shall be practiced at all channels; (2) procurement of all covering all major therapeutic classes and dosage forms, to
about 100 countries.[81] Bangladesh is targeting to progress
medicines by generic INN shall be promoted; (3) in selection
thirty world‑class pharmaceutical industries in the next decade
for procurement, priority shall be given to domestically
to establish a strong position in the international medicine
manufactured medicines; (4) all dispensed medicines shall
markets. Bangladesh country is exempted from obligations
be labeled prominently with the generic INN of the medicine
to implement patents and data protection for pharmaceutical
with or without the brand‑name; (5) a list of interchangeable
products until 2033 as a least developed country.[81] Thereafter,
and noninterchangeable medicines shall be made available;
Bangladesh is allowable to manufacture any patented
(6) generic substitution shall be permitted and legislated for
medicines without taking prior consent from innovator.[79]
all interchangeable medicines; (7) appropriate incentives to
Finally, it has been reported that ‘medicine price in Bangladesh
promote the use of generic medicines and their production in
is currently among the lowest in the world’.[79]
the country shall be introduced’.[73] Nevertheless, another study
revealed the lack of awareness about the regulatory approval
system of generic medicines. Furthermore, negative insights Conclusion
about safety, quality, and efficacy of generic medicines persist The WHO says ‘medicine availability and prices in both public
among different healthcare different stakeholders in Malaysia. and private sectors are key indicators of access to treatment.
In addition, there was a gap between policy construction and Public sector accessibility of generic medicines is  <60%

Advances in Human Biology  ¦  Volume 7  ¦  Issue 3  ¦  September‑December 2017 105


Haque: Generic medicine

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