Marketing of medicines in India
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7443.778 (Published 01 April 2004) Cite this as: BMJ 2004;328:778All rapid responses
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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
Competing interests: No competing interests
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
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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
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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
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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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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.
Competing interests: No competing interests
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.
Competing interests: No competing interests
Re: 5-C technique is more rampant !
It's very true said that some of the companies and big MNCs are doing
this activity, even in some of the companies ( reputed indian
multinational) in their training program of marketing representatives they
teach their executives these 5Cs to get sales benefits .
Infact it is a very well known truth that corruption always starts from
the top to bottom , and if we are really sincere towards this concern
matter than first of all we have to take the initiative ( Specially Drs )
But I personally feel that it's not an easy job, because alone you can not
change the mindset of the people.
The root cause , what I feel is the increasing corruption in the society
specially in the Government sector, that needs to be handeled first of
all.
Competing interests:
None declared
Competing interests: No competing interests