Rapid Responses to:

EDITORIALS:
Chandra M Gulhati
Marketing of medicines in India
BMJ 2004; 328: 778-779 [Full text]
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Rapid Responses published:

[Read Rapid Response] 5-C technique is more rampant !
Sethuraman K Raman   (2 April 2004)
[Read Rapid Response] Difficulty in Prescribing
Mahamood.S Basharuthulla   (2 April 2004)
[Read Rapid Response] Go Generic !
Susheel Oommen John   (2 April 2004)
[Read Rapid Response] A wake up call for all
Nilamadhab Kar   (3 April 2004)
[Read Rapid Response] Educate 3 Ps
Prakash Muttanna Kabbur, Sumana N   (3 April 2004)
[Read Rapid Response] Whirlpool State of Affairs
Mala Raj   (3 April 2004)
[Read Rapid Response] Unethical professional bodies
Pankaj Talwar   (3 April 2004)
[Read Rapid Response] Cozy relations corrupt drug trials
Umesh Jain   (4 April 2004)
[Read Rapid Response] Reasons for Drug Abuse in India
Dr. Kunal Saha   (4 April 2004)
[Read Rapid Response] Vulgar profits pumped into unethical promotion
Kanwaljeet S. Tuteja   (6 April 2004)
[Read Rapid Response] MARKETING OF DRUGS IN INDIA
S J SINGH   (7 April 2004)
[Read Rapid Response] Rampant "sponsored" brand substitution
Ashok Puranik   (7 April 2004)
[Read Rapid Response] Doctors too are responsible
Mangesh V Desai   (7 April 2004)
[Read Rapid Response] Bonus offers - another way to over-drug
Alok Bhattacharya   (8 April 2004)
[Read Rapid Response] Branded generics in India
Krishan Maggon   (9 April 2004)
[Read Rapid Response] Re: 5-C technique is more rampant !
Amit Kumar Arora, 302001   (24 October 2007)

5-C technique is more rampant ! 2 April 2004
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Sethuraman K Raman,
Director-Professor of Medicine
JIPMER, Pondicherry 605006, India.

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Re: 5-C technique is more rampant !

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
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Mahamood.S Basharuthulla,
Consultant Physician & Cardiologist
Starr Hospital Bangalore 560034

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Re: Difficulty in Prescribing

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
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Susheel Oommen John,
Consultant
The Leprosy Mission, CNI Bhavan , New Delhi 110 001

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Re: Go Generic !

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
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Nilamadhab Kar,
Consultant Psychiatrist
Wolverhampton City Primary Care Trust

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Re: A wake up call for all

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
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Prakash Muttanna Kabbur,
Fellow, Neonatal Medicine
University of Connecticut Health Center, CT, USA, 06030,
Sumana N

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Re: Educate 3 Ps

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
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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

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
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Pankaj Talwar,
Army Medical Corps
New Delhi 110017

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Re: Unethical professional bodies

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
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Umesh Jain,
General Practice
Mumbai 400053

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Re: Cozy relations corrupt drug trials

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
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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

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
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Kanwaljeet S. Tuteja,
Consultant physician
Kolkota 700010

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Re: Vulgar profits pumped into unethical promotion

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
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S J SINGH,
Dy C MO, Bharat Heavy Electricals ltd. Hardwar INDIA
HARDWAR 249403

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Re: MARKETING OF DRUGS IN INDIA

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
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Ashok Puranik,
General practice
Datia 475661, India

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Re: Rampant "sponsored" brand substitution

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
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Mangesh V Desai,
Executive-Product
Ahmedabad-India

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Re: Doctors too are responsible

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
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Alok Bhattacharya,
GP
Howrah 711101

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Re: Bonus offers - another way to over-drug

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
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Krishan Maggon,
Pharma R&D Advisor
ICC-20 Route de Pré Bois, PO box 1887, 1215 GENEVA 15, Switzerland

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Re: Branded generics in India

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

Re: 5-C technique is more rampant ! 24 October 2007
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Amit Kumar Arora,
Marketing
Rajasthan,
302001

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Re: 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