E-DRUG: Marketing of medicines in India
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[the E-drug debate habout marketing of medicines in India was also published
in the BMJ. Several interesting responses followed (also reproduced below).
Copied as fair use. WB]
http://bmj.bmjjournals.com/cgi/content/full/328/7443/778
BMJ 2004;328:778-779 (3 April), doi:10.1136/bmj.328.7443.778
Marketing of medicines in India
Informing, influencing, or inducing?
India has a large pharmaceutical industry. A major expansion started in the
early 1970s when the Indian government took two fateful decisions. Firstly,
it decided to permit domestic manufacturers to produce generic versions of
patented molecules without permission from overseas innovators�provided a
different manufacturing process was employed. Secondly, small scale
pharmaceutical units were eligible for huge fiscal incentives and state
subsidies. The new policy led to an unprecedented growth of medicine makers.
Today an estimated 17 000 pharmaceutical companies produce over 40 000
branded formulations, many times more than the rest of the world.
Since the industry has free access to medicines discovered abroad, there is
little incentive to undertake research to make new drugs. Consequently,
nearly all companies are engaged in vicious competition to sell the same
molecules under different brand names. Over 140 brands of omeprazole and
over 120 brands of cefadroxil exist in India. As companies resort to
unconventional methods to sell their brands, ethics take a back seat.
Expanding indications, exaggerating efficacy, ignoring contraindications,
and underplaying adverse effects have become routine practice.
Some recent examples illustrate these questionable marketing methods.
Nimesulide, a non-steroidal anti-inflammatory drug, is being recommended for
use in neonates and infants for undiagnosed fever. The European Medicine
Evaluation Agency has contraindicated its use in children below 12 years due
to its hepatotoxic potential.1 Metoclopramide is marketed for nausea and
vomiting in all age groups including low birthweight neonates,2 though its
use was restricted in the West in the mid-1990s to people aged over 18
years. The Nootropil brand of piracetam is indicated for cortical myoclonus
in people older than 16 years.3 In India, it is recommended for social
maladjustment, lack of alertness, loss of memory, and learning disabilities
in children. Known side effects are conveniently side stepped.
Companies find it hard to generate prescriptions based solely on science.
Relying on published datasheets issued by the inventing companies reduces
the scope of a drug because of the inconvenience of contraindications,
precautions, drug interactions, and adverse effects. Sometimes, for purely
promotional purposes local data are generated, as happened with letrozole,
which was given to over 430 young women to test its efficacy in inducing
ovulation.4
Without new molecules, companies create "novel" products by mixing two or
more medicines in a fixed dose combination. Such combinations are often
irrational, and some pose danger. Short term use of combinations of
quinolones with imidazoles for undiagnosed diarrhoea is encouraging
Salmonella typhi resistance to quinolones.5
Just as elsewhere, gifts and other incentives to prescribers are used by
manufacturers to promote their products�and the methods are often ingenious.
There is little consumer resistance to these practices for two reasons:
faith in the perceived integrity of the medical profession, and lack of
information. An examination of 1200 randomly selected formulations showed
that only 316 had package inserts, and none had patient information
leaflets.6 Many poor, illiterate people in India ask pharmacists for
medicines for common problems such as colds, cough, aches, and pains. In
order to tap this lucrative market, companies produce "branded generics."
These are not promoted to the medical profession, but to pharmacies, which
are offered huge discounts. In the process it is conveniently forgotten that
inducing pharmacies to sell prescription drugs without prescriptions is
unethical and illegal.
The commercial needs of countless, fiercely competing pharmaceutical
companies have led them to depend on the tried and tested 3Cs: convince if
possible, confuse if necessary, and corrupt if nothing else works. It is
easy to find fault with policies adopted decades ago, and the fault may lie
in the regulatory system failing to keep pace with innovations in the
pharmaceutical industry. Nevertheless, the government has failed in its duty
of preventing unethical promotion that has already resulted in misery,
illness, and death.
Chandra M Gulhati, editor
Monthly Index of Medical Specialities (MIMS India), 90 Nehru Place, New
Delhi 110019, India (indianmims@yahoo.co.in)
Competing interests: None declared.
References
1. Rashid T. IMA claims fall flat as EU bans nimesulide. Indian Express
2003;11 Aug.
2. Package insert of Perinorm, Ipca Laboratories Ltd, Mumbai.
3. British Medical Association, Royal Pharmaceutical Society of Great
Britain. Piracetam. British national formulary. London: BMA, RPS, 2003: 246
(No 45).
4. Patranobis S. Drug illegally tested on 400 women. Hindustan Times 2003;21
Dec:p 1.
5. Naik S. Dangers of "two in one" antidiarrhoeals. MIMS INDIA 1999; Dec:
6-8.
6. Lal A, Sethi A, Drug package inserts in India. Ann Pharmacotherapy
1996;30: 1041.[ISI][Medline]
[There are several comments in the e-BMJ; reproduced below FYI; WB)
5-C technique is more rampant ! 2 April 2004
Sethuraman K Raman,
Director-Professor of Medicine
JIPMER, Pondicherry 605006, India.
Send response to journal:
Re: 5-C technique is more rampant !
Email Sethuraman K Raman
Dr Gulhati has said, "...the tried and tested 3Cs: convince if possible,
confuse if necessary, and corrupt..."
In India and several other countries, the marketing ploys include an
upgraded 5-C technique - 1. Convince by facts & figures 2. Confuse by
misrepresenting data or using junk data 3. Coax by appealing to pragmatism:
"All said and done Doctor, your patients expect you to prescribe..." 4.
Corrupt and (if that fails - it does with upright Doctors even today) 5. Cry
(usually a sob story of the plight of being a sales executive with a target
to meet or else...)
Several of my friends experience the 5-C ploy all the time. Infact we have
made a video role-play to sensitise our undergraduate medical students on
how to face up to the 5-C challenge.
Competing interests: None declared
Difficulty in Prescribing 2 April 2004
Mahamood.S Basharuthulla,
Consultant Physician & Cardiologist
Starr Hospital Bangalore 560034
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Re: Difficulty in Prescribing
Email Mahamood.S Basharuthulla
Dear sir I found the article by Chandra M Gulhati about 'Marketing in
India" very interesting.It is true that there are many brands & trade names
for every drug, so that a prescribing physician can hardly remember them
correctly. Even if a givenn drug is prescibed it is often difficult to find
it in a local chemist's shop. As a result the chemist substitutes this with
his own favourite brand!I believe the drug controller should find a solution
to this problem which is rapidly expanding.
Competing interests: None declared
Go Generic ! 2 April 2004
Susheel Oommen John,
Consultant
The Leprosy Mission, CNI Bhavan , New Delhi 110 001
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Re: Go Generic !
Email Susheel Oommen John
The Pharmaceutical Industry in India is exploiting the lack of awareness
among the consumers, the greed of the prescribing doctors and the lax legal
system governing drug manufacturing and marketing. Even premier teaching
hospitals do not emphasise on Generic formulations in the prescribing
recommendations. Branded drugs are promoted ruthlessly based on the
incentives supplied by the industry. There are companies in India that
manufacture high quality Generic drugs at attractive prices that could
drastically bring down healthcare costs, but very few takers. Health care
cost have been found to be the leading cause of impoverishment in
India(Wagstaff A,World Bank report on Health,Nutrition,population and
Poverty 2000) The contribution of drugs and medical supplies to the total
health care cost is approximately 60-70 %, therefore if there is a political
will and strong support from the prescribing doctors, health care costs in
India can drastly be reduced. But is anyone willing to forgo the promotional
gifts and goodies to prevent the poor from becoming poorer ? Is the pharma
mafia going to allow this to happen ?
Competing interests: None declared
A wake up call for all
3 April 2004
Nilamadhab Kar,
Consultant Psychiatrist
Wolverhampton City Primary Care Trust
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Re: A wake up call for all
Email Nilamadhab Kar
It is a matter of grave concern that the process of marketing of medicines
in India has resulted in misery, illness, and death.1 The subject of this
editorial also holds good for many other regions of the world. It is
important to find out what is responsible for this and what are the
solutions.
Doctors prescribing medicines for indications for which, there are no
evidence or no reliable study and prescribing irrational combination of
medication are symptoms of neglecting science and grave disregard for the
safety of the patients. It is a serious problem when medications, which are
contraindicated, are still being prescribed.1
Licensing authorities allowing medications and combinations of medications,
either with no evidence or based on studies lacking scientific rigour and
reliability is another reason. And what about quality control for these
different brands? Does any agency look into that seriously? The law enacting
and regulating authorities failing in their duties in this regard are
contributing to this menace.
Pharmaceutical companies resorting to unethical methods of modifying the
factual information about the medication by expanding indications,
exaggerating efficacy, ignoring contraindications, and underplaying adverse
effects are also responsible.1 Advertisement with suppression and alteration
of facts is obviously unethical and probably illegal.
Most of the preparations do not have patient information with it. The
patient and the carers who do not ask for information or check it properly,
for various reasons, also add to the continuation of this problem. In
addition, most of the medications are available over the counter without a
doctor�s prescription. It becomes a matter of concern for medications for
which a prescription should be required. The pharmacists, who provide these
medications, are doing more harm, as this process is devoid of a medical
evaluation; besides the fact that selling prescription drugs without
prescriptions is unethical and illegal.
So all should share the blame, from doctors who prescribe irrational,
unscientific prescriptions to the public who do not question, along with the
pharmacists, drug controlling authorities and the lawmakers. It may sound
simplistic, but the solution to this problem lies in education: educating
patients to ask about their medications, and educating doctors to practice
evidence-based medicine. At least this should be the starting point.
References
1. Gulhati CM. Marketing of medicines in India. Informing, influencing, or
inducing? BMJ 2004;328:778-779
Competing interests: None declared
Educate 3 Ps 3 April 2004
Prakash Muttanna Kabbur,
Fellow, Neonatal Medicine
University of Connecticut Health Center, CT, USA, 06030,
Sumana N
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Re: Educate 3 Ps
Email Prakash Muttanna Kabbur, et al.
Dear Sir, We would like to respond to the editorial written by Dr Chandra
Gulhati about marketing of medicines in India. She has written interesting
things about the pharmaceutical companies and the way their products flow
into the community. We beleive that we are dealing with a serious problem
with no single simple answer/solution.India has a significant percentage of
population below poverty line and considerable number are illiterate also.
We agree with the author that presciption of many medications by the doctors
is influenced by the gifts and incentives given by the pharmaceutical
companies,especially in the private owned hospitals .The same problem is
pretty rampant in non-allopathic medical fields like ayurveda and
homeopathic medicine. In our view, one of the solutions is the "EDUCATION"
of 3 P`s 1.Public: Educate the public to ask the prescribing doctor about
the details of the drug, like side effects, cost,etc. This is achieved best
through public media, like television or radio. 2.Physicians: Educate the
physicians regarding their DUTY to reveal the details of the medicines they
are prescribing to their patients who trust them. 3.Pharmaceuticals: Educate
the pharmaceutical personnel regarding their obligation to give the best to
the public and not just to concentrate on how much profit they can make
through selling their products and also to reveal the best possible
information both to the physicians and the public. The 4th and 5th P`s would
be strict Policies by the local governing bodies and strict use of
Presciption drugs.
Competing interests: None declared
Whirlpool State of Affairs 3 April 2004
Mala Raj,
Marketing Consultant
Product Management Support Services, 83/704, Panchavati, Vasant Vihar,
Pokhran Rd.No.2, Thane
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Re: Whirlpool State of Affairs
Email Mala Raj
3rd April 2004
It is a matter of shame that an average individual today thinks purely of
personal gains rather than betterment of the society. Few ponder to reflect
on ethics & values that they follow while discharging their professional
duty. No wonder then that, while the Pharma Industry rampantly corrupts the
prescribers, the Medical Profession shamelessly allow themselves to be
corrupted and go on to make greater demands on the Pharma industry. Both are
to be blamed for this murky state of affair that, like a whirlpool, has
almost no way to get out from. What is true of India is true in the rest of
the world too.
The net result, as Dr Gulati has pointed out is gross misuse of drugs.
Over-prescribing, prescribing for wrong & un-approved indications have
become the order of the day. What is also worrisome is that quality of the
drugs / brands prescribed have taken a back-seat. This coupled with lack of
awareness of the average Indian patient and the in- efficient legal system
has further worsened the situation.
Greed is winning over conscience. And the ultimate loser is the hapless
patient, you & I, the whole society�..
Can things can improve?? If & Only If the following �Ifs� are met with�
If the Pharma Industry arrive at a consensus on the kind of ethical
Promotional activities that they will indulge in & a fool-proof method of
implementing the same���.
If the Indian Medical Association lays down guidelines for ethical
prescription and moral conduct which they can enforce on their members���.
If the FDA officials take stringent measures against sub-standard drugs,
irrational combinations & promotion of drugs in unapproved indications���. .
If the average consumer / patient takes the effort to become more aware and
starts questioning his Physician more often ���..
If wishes were horses��..
Mala Raj
Competing interests: None declared
Unethical professional bodies 3 April 2004
Pankaj Talwar,
Army Medical Corps
New Delhi 110017
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Re: Unethical professional bodies
Email Pankaj Talwar
While I am in full agreement with the views expressed by Dr. Chandra M.
Gulhati on the ills of marketing practices in India, I wish he had also
touched the utter irresponsibility on the part of some professional
associations of doctors in India.
One has just to go to one such conference to see the nexus between producers
and prescribers. Let alone other inducements, even breakfasts, luncheons and
dinners are sponsored by drug companies.
When ever a drug has come under cloud for valid scientific reasons be it
cisapride or nimesulide, pharmaceutical manufacturers have used professional
bodies to intercede on their behalf with the regulators. Indian newspapers
are full of such factual stories. The issue is not why pharma companies use
medical associations but why professional bodies allow themselves to be
used. The same argument applies to individual doctors. Why do they accept
expensive gifts in return for prescriptions? It is nothing but breach of
trust - a criminal offence in India.
Competing interests: None declared.
Cozy relations corrupt drug trials 4 April 2004
Umesh Jain,
General Practice
Mumbai 400053
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Re: Cozy relations corrupt drug trials
Email Umesh Jain
The cozy relations between drug producers and prescribers in India goes far
beyond ensuring enhanced sale of preferred brands. Its corrupt effect can be
felt on the �doctored� results of drug trials conducted solely for
regulatory approval.
Thousands of irrational Fixed Dose Combinations (FDCs) are sold in India. As
per legal provisions, no FDC can be approved without clinical trials. It is
an �open� secret that pharmaceutical manufacturers in connivance with
investigators can get favourable results of trial of any combination. Some
examples are:
(a) norfloxacin + tinidazole + loperamide, (b) nimesulide + paracetamol +
tizanidine, (c) propranolol + diazepam (d) doxycycline + tinidazole.
In no other country such dangerous combinations are allowed. God Save Indian
Patients!
Competing interests: None declared.
Reasons for Drug Abuse in India 4 April 2004
Dr. Kunal Saha,
Assistant Professor
Children's Hospital and Ohio State University Medical Center, Columbus, Ohio
43205, USA
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Re: Reasons for Drug Abuse in India
Email Dr. Kunal Saha
The report �Marketing of medicine in India� is appalling but hardly
surprising for doctors like myself who have graduated from India but have
settled in a developed country. The unscientific use of potentially
dangerous drugs by a large fraction of the registered doctors of India for
mere personal gain, financial or otherwise, is well known. The failure of
the moral standard of many medicos in India probably reflects the general
decay in principles in the Indian society at large. There is little doubt
that corruption that has infiltrated various aspects of Indian life, not
just in medicine, is primarily responsible for such immoral use of drugs on
Indian patients. People of the medical community in countries like India
should not be totally oblivious about their �Hippocratic oath� and the
exclusively noble nature of their profession. They should remember that the
mere gain of a �gift� for favoring a dangerous drug may result in the
needless loss of a human life and devastate many others who are left behind.
The example of gross abuse of �Nimesulide� and other drugs in India is not
new1-3. �Nimesulide� is banned in the USA and in spite of the recent EU
approval of its use in the adults, the scientific world has remained
unanimous about the danger of �Nimesulide� in the younger children4. It is
shameful that the Indian medical authority has still remained listless about
the rampant pediatric use of �Nimesulide� 3. Not just the use of improper
drugs, many doctors in India frequently violate the basic norms for using
any medicine. I�ve the personal knowledge where an Indian physician
prescribed �Depomedrol� (methylprednisolone acetate), a long-acting
corticosteroid, at 80 mg BID (twice daily) for an acutely ill patient of
severe drug allergy (SJS/TEN). �Depomedrol� is used at 40- 120 mg at 1-2
week intervals and is generally recommended for chronic conditions like
�bronchial asthma� or �arthritis� for convenience in the steroid use. It is
common knowledge that any long-acting (�depo�) preparations are not to be
repeated at frequent intervals. In the US, prescription of such an excessive
level of a drug would likely to be stopped by the pharmacist as an overdose
of this magnitude would raise an automatic �red� alert. Unfortunately, there
is no second checking system in place for wrongly prescribed medicines in
India and once prescribed by a doctor, drugs are freely supplied by the
pharmacist. Even in the event of an unintentional error in the prescription,
the wrong �drug� or the wrong �dose� would be applied putting the life of
the patient in grave danger. Reports of unfortunate death of patients from
wrongful prescription frequently appear in the news in India where both the
doctor and the pharmacist blame each other for the costly lapse.
The basic problem in Indian medicine stems from the absolute lack in any
�checks and balances� for the members of the medical community. Not just the
ethical violations, even gross medical violations are routinely ignored by
the medicine regulatory agencies like the �medical council� in India. It has
become common knowledge that the �medical councils� in India always shield
the errant doctors without caring for the lives of the victims of medical
negligence. Statistics would also support this notion since unlike in the
West, hardly any doctors are found guilty or disciplined by the �medical
council� in spite of rampant evidence of medical and ethical violation by
the Indian healers. Influence on the Indian doctors with unlawful incentives
by the drug companies for advising dangerous and even banned drugs on Indian
patients is not likely to stop unless stringent measures are taken to weed
out the deeply rooted corruption from medical system in India. Thank you.
References:
1. Kumar S. Drug linked to child death is still available in India. BMJ
2003; 326: 70.
2. Mudur G. India admits to unapproved drug formulations in market. BMJ
2003; 326: 1286.
3. Malhotra S, Pandhi P. Analgesics for pediatric use. Indian J Pediatr
2000; 67: 589-590.
4. EMEA Committee for proprietary medicinal products 22-24 July, 2003
Plenary Meeting Monthly Report.
Competing interests: None declared
Vulgar profits pumped into unethical promotion 6 April 2004
Kanwaljeet S. Tuteja,
Consultant physician
Kolkota 700010
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Re: Vulgar profits pumped into unethical promotion
Email Kanwaljeet S. Tuteja
First of all I would like to congratulate BMJ for bringing to light the the
issue of unlawful and unethical promotion, a disesae afflicting India.
While in his brilliant expose, Dr. Gulhati has touched many aspects, I
believe one issue has not been dealt with. Since companies in India are free
to copy foreign medicines without royalty payments, their profit margins are
sometimes sky high. Let me give you just one example. The controversial drug
Nimesulide is being marketed by over 70 companies. One of the largest Indian
companies sells 10 tablets of 100mg nimesulide for about Indian Rs. 4 to
chemists. Another much smaller company sells exactly the same product for
Indian Rs. 25. In other words, there is a difference in the price of two
brands to the tune of over 600 per cent!
These vulgar profits are handy and helpful in undertaking all sorts of
activities to promote the product. Even though the Indian Government has a
special organisation called National Pharmaceutical Pricing Authority to
stop vulgar profiteering in medicines, no action has been taken. Will the
Authority explain the reasons?
Competing interests: None declared
MARKETING OF DRUGS IN INDIA 7 April 2004
S J SINGH,
Dy C MO, Bharat Heavy Electricals ltd. Hardwar INDIA
HARDWAR 249403
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Re: MARKETING OF DRUGS IN INDIA
Email S J SINGH
Dear Sir
This has reference to "Marketing of medicines in India "(BMJ
2004;328:778-779 (3 April), doi:10.1136/bmj.328.7443.778) Congratulations
for presenting the true picture of pharmaceutical and "chemist" industry in
India.
But the author has not mentioned about the "Brand Substitution" by the
chemists, irrespective of the prescriptions, where dispensing is determined
by the "returns" and margins. An alarming nexus which is emerging is between
the doctors, nursing homes and chemists, where "Branded Generics" are pushed
forward for mere cost benefit.
There is urgent need to arrest such malpractices.
Regards
Dr S J SINGH
N-84 SHIVALIK NAGAR HARIDWAR 249403
EMAIL esjeyes@bhelhwr.co.in
Competing interests: None declared
Rampant "sponsored" brand substitution 7 April 2004
Ashok Puranik,
General practice
Datia 475661, India
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Re: Rampant "sponsored" brand substitution
Email Ashok Puranik
Many pharmaceutical firms in India bribe chemists and druggists to
substitute prescribed brands. The bribery is either in the form of higher
discounts or free medicines. This may not be very common in large towns
where literacy is relatively high but in small towns, this is happening all
the time. Poor villagers cannot read, specially, English and hence are taken
for a ride.
Competing interests: None declared
Doctors too are responsible 7 April 2004
Mangesh V Desai,
Executive-Product
Ahmedabad-India
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Re: Doctors too are responsible
Email Mangesh V Desai
Not only the Pharma companies and the sales professionls but also the
doctors are equally responsible for spoiling the system because being in the
pharma industry I know very well that before prescribing a product most of
the Doctors will see what will be there gain and not the benefits of the
molecule or product.(but all Doctors are not like that)
Mangesh Desai
Competing interests: None declared
Bonus offers - another way to over-drug 8 April 2004
Alok Bhattacharya,
GP
Howrah 711101
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Re: Bonus offers - another way to over-drug
Email Alok Bhattacharya
For too long, all the stakeholders (companies, chemists, doctors) except
patients have been sweeping all the ills of pharma marketing in India under
the carpet. It is heartening to see that at least one �whistleblower� has
come out in the open. My congratulations to BMJ for publishing the
editorial.
Many companies in India, including well known MNCs, resort to Bonus offers.
If a retail pharmacy buys 70 bottles of ofloxacin suspension, it is given 40
more bottles free of charge. An internationally known Indian company is
currently giving one strip of diazepam free with 11 strips for which payment
is made. Even the Indian version of Viagra is available as a bonus: 1 strip
of 4 tablets for every 2 strips purchased.
The entire additional income is pocketed by pharmacies. The reason that free
supplies are made instead of price reduction is to maintain profits. Since
the number of patients and disease pattern does not rise even when Bonus
offers are in place, additional supplies are used to over- drug the people.
Competing interests: None declared
Branded generics in India 9 April 2004
Krishan Maggon,
Pharma R&D Advisor
ICC-20 Route de Pr� Bois, PO box 1887, 1215 GENEVA 15, Switzerland
Send response to journal:
Re: Branded generics in India
Email Krishan Maggon
Dr. Gulhati has raised several key points about the marketing of local
copies of new drugs in India. The approval of new molecules in India is like
an automatic fast "abbreviated new drug application" relying on the
innovator company data in the public domain.
The approval and marketing of over 400 brands of nimesulide and in
combinations is confusing to the doctors, pharmacists and patients. Any
unsuspected doctor or pharmacist may prescribe two different brands of
nimesulide for two indications in the same patient resulting in overdosing
and toxicity. Any resulting toxicity will go unreported in the absence of an
effective adverse event monitoring system.
One suggestion will be to recognise only the innovator company product with
a single global brand name. In case of nimesulide it can be Aulin
(Nimesulide) by Helsinn. All other copy products should have the generic
name in bold followed by company names: Nimesulide by companies X, Y and Z.
Adoption of this practise in India and all over the world will eliminate
confusion created by hundreds of brands of a single molecule. Elimination of
branded generics will reduce dosing errors, drug overdosing and resulting
toxicity.
Competing interests: None declared
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