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Dear Vijay sir,

You are rigt in saying that availability of OTC drugs EMPOWERS

the patients.But in country like India its not only the safe drugs but

even prescription antibiotics are freely available over the

counter.One only needs to know the brand name of the said drug.While

it helps the patient to some extent but it may do a lot harm in the

long run

Dr.Santosh

In netrum , " Vijay " <drvijaythawani@...> wrote:

>

> Hi,

> I strongly feel that availability of OTC medicines improves access

to

> such medicines and in turn " empowers " the patients. So finally the

> patient decides what to buy unlike when the doctor prescribes and

> takes the decision on patient's behalf.

> We must realize that it is patient's body which is dosed with

medicine

> and patient pays for such intake. So ethically patient should have

> power over the purchase.

> But then the OTC must be meant for only safe medicines. Moreover the

> patient must get all the information about the OTC medicines.

> Vijay

>

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Hello,

1. In India, non-prescription medicines do not have/carry any information leaflet.

2. What we need is that is must be mandatory that every OTC medicine should contain a PPI (Patient PAckage Insert) - with patient specific information about the medicine - its indications, cautions/spl precautions, ADRs, dosages, when to refer to doctor, maxmum dosages, maximum duration of self-medication, etc. This will have to be in local languages too.

3. Besides, this the labels must carry more information than they carry today - so that the patient can comprehend at least the most important things at once - and can refer to the PPI and understand more things about the product they are going to consume.

4. In most developed countries, the labelling is quite extnsive - patient oriented, and the PPIs also are compulsorily present, and give pateitn specific useful information about using the drug.

Raj Vaidya

Community Pharmacist

GOA

On Wed, Sep 17, 2008 at 8:50 AM, kunda gharpure <gharpurekunda@...> wrote:

hello,

such an interesting discussion is taking place that I cannot resist posting my view on this topic.

In the first place why medicines are available OTC ?

We should not have any objection to this, since we agree that an individual is responsible for his own health.and professionsal care for minor ailments is unnecessary.

I do not say that there is no role of a doctor in health management but what we should realise is, that for every sneeze the patient should not and cannot seek a doctors help.

When we talk of OTC medicines, our first assumption is that the patient is capable, mentally and intellectually , to take care of his health.

It is here that the people fail and therefore all the other stakeholders make hay.

To solve this situation,

Industryshould conform to the labelling requirements.

FDA should be strict in enforcing the rules.

Doctors should educate the patient on following instructions religeously.

Pharmacists when issuing OTC medicines must give complete information to the patient even if it is there on the label.

And finally the patient should learn to ask questions about his medication.

I know all this sounds too much to seek for.

well, let us at least make an attempt.

kunda

Unlimited freedom, unlimited storage. Get it now

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Thanks Professor Rao.

Keep blessing.

Vijay

>

> From: Vijay <drvijaythawani@...>

> Subject: OTC medicines

> netrum

> Date: Wednesday, 17 September, 2008, 6:03 AM

>

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>

> Hi Smita

> I could retrieve this MS, which the journal did not dare to

publish. It answers my point made in previous post. It remains

unpublished but is a factual information and we the authors stand

by all that has been stated therein.

> Vijay

> ------------ --------- --------- --------- --------- --------- ----

----- --

> The return of old wine to old bottle

> Dr Vijay Thawani , Mrs K. J. Gharpure  , Manasi Thawani

>

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> While old wines are precious and connoisseurs delight,

>  giving new wine in old bottle is downright cheating.

>  Pharmaceutical companies have been attempting the trick of

replacing the formulation of their popular brands.

>  This case history relates to one such popular brand,

> where the changeover was resented,

> resulting in negative impact on the sale of the new brand.

> Finally the company returned the old formulation in old brand.

> Old wine did return to old bottle.

>  

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>  

> Commenting on the marketing gimmickry in medicines, a medical

activist anguishly expressed - " It is only in the poorly

administered third world countries like ours, having outdated laws,

inefficient drug authorities, callous population, ignorant medics,

unorganized patients and impotent activists that trans national

companies (TNCs) are able to exploit the prevailing situation in the

drug industry to suit exclusively their interests " .1

>

> The consumers of the third world continue to be at the receiving

end, getting the third rate treatment at the hands of the industry.

Lot of junk in the name of medicines is sold in the market under the

garb of international formulations that have been banned in the

parent country of these international giants 2. TNCs not contented

with dumping their outdated, obsolete, bannable, dangerous and

hazardous formulations have adopted the technique of packing new

formulation in the name of old brand name, without bothering to

timely inform the consumers of such changeovers. Such sickening acts

cannot heal the sick.

>  

> Since the only motto of the industry is to amass wealth in all

possible ways, its best efforts are concentrated towards financial

gains at the cost of patient welfare. While attempting this goal,

obviously ethics are relegated to back seat. Because of the havoc of

the branded medicines, generic prescriptions have been advocated.

Since not many support the generic move, the result is over

popularization of the brand name, encashment on brand name and

subsequent exploitation through the brand name. Due to brand fancy

the patients are attached to a particular brand and faithfully

continue to provide business to it. Little do patients realize that

the manufacturers by changing the formulation in it, misuse their

trust and faith reposed in the brand.

>

> It is mockery of the existing rules if bureaucracy is not willing

to change its antiquated laws and ban the launch of new formulation

in the name of old brand. Rules should enable able governance of

capable administration, which must cherish life to thrive and not

endanger it. Several brands like Suganril, Esgipyrin, Spasmindon,

Baralgan, Relaxyl are known where the goodwill of the brand was

encashed by the pharmaceutical companies by substituting the

medicine in them 3. This recent case history relates to the

unethical changeover of contents of Disprin manufactured by Reckitt

Benckiser ( India ) Ltd.

>  

> Disprin, known for its aspirin content (acetyl salicylic acid

along with calcium carbonate and citric acid) is a popular OTC

product. Realizing the great potential of its brand   name the

company launched " Disprin Plus " with fanfare. It was noticed that

the new " Plus " was actually minus the aspirin. By prefixing Disprin,

it wished to retain the old consumers aware of the brand and by

suffixing it with  " plus " (without adding anything) eyewash all.

The semantic jugglery was attempted to escape the dictum to sale

aspirin at cheaper price, replacing aspirin with paracetamol. To

prop-up the market of the costlier alternative (paracetamol) it even

claimed, " introducing new formula " and gave misleading

advertisements that it (paracetamol) gives " fast relief from pain " .

>

> When these facts were brought out, the Disprin consumers were

foxed. Cardiac patients taking half tablet for its platelet

inhibitory effect were in for a shock. All of a sudden Disprin ran

in short supply and was missing from the shelves of pharmacy shops.

Disprin Plus neatly replaced it. Not aware of the difference, the

loyal patients of Disprin changed to Disprin Plus, little knowing

what this switchover could have done. Many of the prescribing

doctors wereignorant about this substitution till the press blew the

whistle 3. The manufacturer had taken all for a ride. The

pharmaceutical giant was probably also involved in the arm-twisting

to establish the new product, since it appeared in the press that in

case the company pressurized the retailers to sell Disprin Plus,

then the state body of Chemists and Druggists Association should be

informed 4.

>

> The unsavory mechanics started as aspirin was brought under the

Drug Price Control Order (DPCO). National Pharmaceutical Pricing

Authority (NPPA) notified ceiling prices for aspirin and 20 other

formulations. It was just another routine exercise for the price

regulator agency after taking into consideration the prevailing

manufacturing costs and market prices of the bulk drug involved 5.

Well-known brands of aspirin like Disprin of

> Reckitt, Aspro of Piramal, Aspirin of Cipla, Codopyrin of

Glaxo, Dispersible Aspirin of Astra started disappearing from the

retail outlets. It seemed more like a ganged response. It was

collective irresponsible act of the pharma industry because they

were not willing to provide aspirin at lower profit margin. Reckitt

and thought they were smarter and utilized their brand

advantage to introduce Disprin Plus and Aspro Plus respectively,

with a different drug †" paracetamol 5. Disprin was sold at 2.25

per 10. The companies opted out from selling it at the dictated

price of Rs 1.70, and instead changed over to paracetamol pricing

Disprin Plus at 9.40 for 10 (taxes extra). The economic interest

sacrificed the sanctity of medicine business, killed the patient

interest, butchered the ethics and massacred the morality.

>

> While the doctors and patients were still trying to figure out

what was happening, Monthly Index of Medical Specialties (MIMS

India) carried the entry of Disprin Plus in September 2001, with

update of 31 August 6, obviously with the feed from the company.

Another timed release was a free booklet " How to combat pain " 7

sponsored by Reckitt which accompanied the 16 Sept 2001 issue of the

magazine " The Week " . It carried three full pages of same copy of the

advertisement of Disprin Plus and its vignette logo on all the 30

pages of booklet. That this contained paracetamol appeared in the

smallest font size. The company concentrated more on popularizing

the new brand rather than making effort to inform the patients with

drug information. It matched the action of intoxicated drunkard

taking support of the lamppost, which was more intended to keep it

erect rather than for illumination.

>

> It was a rare case of solidarity, when the Druggists and Chemists

Association of Nagpur boycotted the new product Disprin Plus. Their

apex body All India Organization of Chemists and Druggists (AIOCD)

took up the matter with the company about the confusion in the brand

names. It brought to the notice of the company that the addition of

the word " Plus " created the prima facie impression that the drug was

basically aspirin with something in addition. The similarity of the

design of the strip pack led the consumers believe it was the old

medicine. The addition of the words in red colour- " new formula "

made one believe that it was improved formulation. The AIOCD also

drew the attention of the manufacturer towards the section 17 (a)

and © and section 17-B (a) and (B) of the Drugs and Cosmetics Act

1940, which relate to misbranded and spurious drug, to warn them of

the penalties 4.

>

> India has lot many acts, rules and laws. The Indian Merchandise

Marks Act of 1889 is concerned with the misbranding of goods in

general and provides for penalizing any false mark upon the

containers of the goods in a manner, which may deceive any person as

to the kind, nature or quality of it. Consumer Protection Act 1986

defines unfair trade practice as one which for the purpose of

promoting the sale, use or supply of any goods, adopts any unfair

methods or deceptive practice. Section 36 of MRTP Act 1969 specifies

that the consumer has a right to be informed about the quality,

quantity, potency, purity, standard and price of the goods so as to

protect the consumer against unfair trade practices. When a problem

arises as to whether a particular act can be condemned as an unfair

trade practice or not, the key to the solution would be to examine

if it does lead a reasonable person in the position of a buyer to a

wrong conclusion 8. In spite of such laws of

> the land, how the industry gets away, indicates system

performance.

>

> Shaken by the statewide boycott in Maharashtra , the adverse

publicity hit the company where it hurt most - the sales. Loyal

patients of Disprin switched over to other brands. Reacting to the

continuing criticism, Reckitt Benckiser inserted advertisement " for

public information " 9 half-heartedly informing about the difference

between Disprin Plus and low dose aspirin. But the damage control

exercise failed. The concern due to falling collections in cash

registers was evident. Finally after about two years, around July

2003, the company showed its delayed professionalism by withdrawing

Disprin Plus and making Disprin re-available in India for retail

price of 2.70 for 10 (120 tablets for 31.56, taxes extra). The

battle was won. Old wine was returned to the old bottle. May this

sordid saga leave indelible mark so that others desist from such

misadventures.

>  

> References: 

>  

> 1.Medical Activist. Letter to Editor. The Hitavada, Nagpur , Sept

19, 2001 .

>

> 2.Vandana Shiva. In Banned and Bannable Drugs. Voluntary Health

Association of India , New Delhi .

>

> 3.Diwe Rajendra. Disprin plus minus aspirin foxes patients. The

Hitavada, Nagpur , Sept 6, 2001 .

>

> 4.Diwe Rajendra. Statewide boycott of Disprin Plus. The Hitavada,

Nagpur , Sept 12,2001 .

>

> 5.Chronicle Pharmabiz. Aspirin Shortage: Industry at fault.

Editorial. Chronicle Pharmabiz. Vol 1, No 46, Nov 1, 2001 ,P 8.

>

> 6.MIMS India . Vol 21, No 9,Sept 2001, Page 74, Col 3.

>

> 7.The Week. How to combat pain. Sept 16, 2001 , PP 1-32.

>

> 8. Avtar Singh. Law of Consumer Protection: Principles and

Practice. 3rd edition, P 125. Eastern Book Company.

>

>

> 9.Times of India , Mumbai. Sept 14, 2001

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> Unlimited freedom, unlimited storage. Get it now, on

http://help./l/in//mail/mail/tools/tools-08.html/

>

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  • 2 years later...

Dear Geer Ishaq sir,

I completely agree with your opinion that pharma companies should take consumer

centric approach in designing OTC products where priority should be given on

consumer education and there by his empowerment. I think packaging of OTC

medicines in multilingual and simple language will be better for Indian market

since it can be more customized and is less costly.

Regards,

Dr. Mangesh Bankar

Assistant Professor,

Pharmacology,

GMC, Nagpur.

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