abstract asia pacific edited kunal

8/6/2019 Abstract Asia Pacific Edited Kunal

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Overview:

With an average operating margin of 20.2 percent for

the leading companies between 2005 and 2008, and amarket size of $450 billion in 2008.Speaking

specifically of the Indian market, she says an upturn of10.7 percent made it one of the fastest-growingcountries in terms of OTCs .The Indian OTC market is

estimated to be about Rs. 7434 crore in 2008 ($ 1.8billion).Segments such as cough & cold preparations,analgesics, vitamins & minerals and indigestion

preparations account for a little over Rs. 2700 crore.The Indian pharma market in comparison is valued at

about $ 8.4 billion in 2009. It grew at about 12 percentCAGR from 2002 to 2007 while it is expected to reach $20 billion by 2015 (CAGR of 16 percent from 2009 to

2015), as per ORG IMS estimates..Traditional medicine(Ayurvedic) accounts for approximately Rs 1600 crore+while other segments such as medicated skin products,

topical OTC medicines, plasters and bandages, anti-smoking aids, etc collectively account for over Rs 3000

crore.

Paradigm shift in otc:

The early birds who adopted an OTC-focussed strategyin the Indian pharma market are already reaping rich

rewards. Ranbaxy was one of the first domesticcompanies to foray into the OTC segment in 2002,


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through a separate business division called Ranbaxy

Global Consumer Healthcare. The division started with

four products Revital, Garlic Pearls, Pepfiz andGesdyp all of which were prescription drugs turned

into OTC products. In 2008, the consumer healthcareunit of Ranbaxy clocked sales of $44 million, growing at25 percent. That year the companys total sales were

$1.66 billion, with a growth of eight percent. Food

supplement Revital has now become one of Ranbaxystop-selling products, even outpacing some of its top

selling prescription brands. Nair points out that fromJanuary to July in 2009, Revital earned Rs 66 crore for

Ranbaxy as compared Rs 63 crore for Mox, its highest-selling antibiotic.

Other successful OTC products include Sugar Free fromZydus Cadila, which earns about Rs 80-85 croreannually, compared to hypertension drug Aten (Rs 70

crore). The emergency contraceptive i-Pill, launched byCipla in August 2007, became one of its best selling

products, garnering revenues of Rs 30 crore within just

two years of its launch, inspite of (or maybe even aidedby) its slightly controversial positioning. In fact,

Piramal Healthcare considered i-Pill such an attractivebuy that it was willing to cough up three times its sales Rs 95 crore-- in order to grow its OTC business. The

buy makes even more sense when you consider that

emergency contraceptives are the fastest-growing OTCcategory in the country following their switch to OTC in

2006.


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Change in otc advertisement from

push to pull

The opportunity exists, but domestic pharma

companies have realised that marketing OTC products

requires a different set of skills. "In the direct tocustomer (DTC) world, the consumer makes his or her

own choice by getting exposed to and influenced byadvertising and other media. An informed consumer,who is predominantly present in the urban markets, is

exposed to advertising or could be exposed to afriend's experience, and he/she consciously takes a

decision to buy a product. These consumers interact

with the OTC product in ways that are different frominteracting with a prescription drug where the

influencer is the doctor. The OTC product will need tobe treated as a fast moving consumer goods (FMCG)

product specially while communicating a benefit,ensuring distribution or ensuring consumer friendly

packaging."

"The biggest challenge for pharma companies dealingin OTC products is that, unlike the traditional pharma

model of pushing generic products by selling to

doctors, the OTC segment is more analogous to theFMCG segment. It is critical to invest in brand building

that will create a pull for the product directly from the

consumers. Brand building has traditionally been thestrength of FMCG companies (e.g. Procter & Gamble(Vicks), GSK Consumer (Eno fruit salt)) and is a skillthat will need to be rapidly developed by pharma

companies."


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Pharma companies therefore have to learn to think like

their FMCG counterparts. These include focussing on

improving penetration through traditional FMCGchannels, like grocery stores, which will also help

pharma companies make the transition from selling todoctors to direct contact with consumers. Today, OTCpreparations for cough and cold, antiallergic, balms, or

a low dosage of some safe non-steroidal anti-

inflammatory drugs (NSAIDs) are also stocked withgrocers / paan stores in India. This improves both

penetration and margins of OTC products.

Another gambit is using the traditional FMCG sachet

concept for OTC pharma products to penetrate rural /tier 2 markets, which have untapped growth potential

due to their price-sensitive nature creating marginpressures. Paras Pharmaceuticals, for instance, hasintroduced smaller pack sizes for pain balms to drive

up consumption. Given the fact that primary /secondary healthcare is often inaccessible or expensive

in these markets, OTC products have the potential to

fill the void through good brand-building andpenetration at the right price points.

Two other key factors: the role of distribution and

trade channels. According to him, "Distribution is of

critical importance because while advertising will helpto create a demand for the product, distribution

ensures that the consumer interacts with the brand andmay take a purchase decision without the consumer

having to run to 10 or 15 shops to locate thehealthcare brand. Similarly, engaging with the trade

will be extremely important because these businesspartners can make a huge difference to the success or

failure of a brand."


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Growth rate of otc segments:

Growth rates of different OTC categories

Sales inUS$mn (MSP)

2009 09/08/10 CAGRYr

14/09

CAGRYr

19/14

Majorcategories -

India

1813.410.7 10.2 10.8

Vitamins,Minerals &

Supplements

634.5 8.8 9 10.2

Gastrointestinals 332.6 10.4 10.3 10.7

Cough, Cold &Allergy

318.1 7.8 9.7 9.9

Analgesics 258.7 15.8 10.3 10.6

Dermatologicals 236.5 11.3 11.9 12.7

Lifestyle OTCs 33.2 38.9 20.8 13.6

Data Source : Nicholas Halls DB6 2010*


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Top brands in otc globally:

Top 10 global OTC brands

Leadingbrands

(Sales$Milllion)

Global

2008

90965.1

2009

95193.2

Grth'09/08

4.6

1 Tylenol 1449.9 1452.5 0.2

2 Vicks 871.5 880.9 1.1

3 Halls 792.3 830.6 4.8

4 Lipovitan 854.5 812.9 -4.9

5 Aspirin 796.1 798.5 0.3

6 Advil 716.3 722.1 0.8

7 Centrum 695.2 693 -0.3

8NatureMade

577 639.1 10.8

9 Nicorette 525.8 525 -0.2

10 Claritin 514 488.1 -5

Data Source : Nicholas Halls DB6 2010*


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Characteristics in O.T.C ads: ( example no1 O.T.C brand Tylenol )

OTC Advertisement in India Regulations:

TheDrug & Magic Remedies (Objectionable Advertisement) Act &Rules mentions a list ofailments for which no advertising is permitted. It also prohibits false

ormisleading advertisements


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whi h, di tly ori directly, gi e fal e im ressions regarding the true

character ofthe drug, make

false claims, or are otherwise false ormisleading in any particular

respect The DCGIs office -in

collaboration with the Organi ati n of PharmaceuticalProducers ofIndia (OPPI) - has released a

Voluntary Code on OTC Advertisingwhich is being followed by all

OPPI member companies.

There is also an OPPI Code of PharmaceuticalMarketing Practices,

January 20071, based on the

IFPMA code. Based on the DCGI code, the Advertising Standards

Council of India (ASCI) has

brought out a code of advertising for pharmaceutical products.

Currently, there is no specific law which prohibits the advertising ofprescription drugs although

industry practice is notto advertise prescription-only drugs. The

DCGIs office is considering

coming out with a notification prohibiting the advertising of any drug

which legally requires a

doctors prescription forits supply.

GERMAN CODE OF CONDUCT:

3. Section: Advertising

7 Prohibition against misleading advertising(1) Misleading advertising is prohibited.

(2) A deception exists in particular

1. iftherapeutic effectiveness or effects are attributed to prescription-

only

medicinal products thatthey do not possess,2. ifthe impression is falsely created that

a) success can be expected with certainty,

b) that no harmful effects will be experienced ifthe medicinal product

is taken as

directed or over a long period oftime,


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c) the advertisementis not being produced for purposes of

competition,

3. if untrue ormisleading statements are made

a) with regard to the composition or characteristics of drugs,

medicinal products,devices or othermedia orthe manner of procedures ortreatments or

b) aboutthe person, priortraining, qualifications or successes ofthe

manufacturer, inventor orthe persons performing forthem or who

have

performed forthem.

(3) When determining whether withholding a factis misleading, its

suitability for

influencing the prescribing decision ofthe health professionals

addressed mustparticularly be taken into account.

(4) Advertising must be supported with sufficient scientific

documentation and may not

contradictthe specifications in the technicalinformation. This applies

especiallyto

promotionalmessages that referto certain advantages, qualities or

characteristics of a

medicinal product or active ingredients. Promotionalmessages about

side effects mustalso reflect all available findings or be documented with clinical case

studies. Statements

that have already been included in the approval of a medicinal product

require no further

scientific verification. Ifmembers ofthe health professions so request,

the appropriate

scientific documentation must be made available to an appropriate

extent.

(5) Medicinal products may be designated as "safe" only when thecorresponding

scientific documentation is available.

(6) Sweeping statements that a medicinal product has no side effects,

toxic hazards or risk


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of addiction or dependency are prohibited. Statements that certain

side effects, toxichazards or risks involving addiction or dependency

have notyet been identified are

permissible onlyifthey are supported with sufficient scientific

documentation.(7) Drugs may be designated as "new" only within one year afterthey

have been initially

placed on the market;indications only within one year since they

were first advertised.

8 Prohibition against covert advertising / transparency precept(1) The promotional nature of advertising activities may not be

concealed.

(2) Advertisements that are paid for or released by a companymust bedesigned so that

they cannot be mistaken forindependent editorial statements.

(3) With respectto publications bythird parties aboutmedicinal

products and their use

which are financed by a companyin their entirety orin part, care must

be taken to ensure

thatthese publications very clearly state thatthey are financed bythe

company.

9 Prohibition against advertising non-approved medicinal

products and nonapproved

indicationsAdvertising medicinal products that require pharmaceutical approval

is permissible only

ifthey have been approved. An advertisementthat refers to

therapeutic applications or

forms of administration, which are not covered bythe requirement for

approvalisprohibited.

10 Mandatory specifications(1) Each advertisement formedicinal products within the meaning of

2 para. 1 or para.


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2 no. 1 ofthe Medicinal Products Actmust contain the following

specifications:

1. the name orthe company and the registered office ofthe

pharmaceutical

entrepreneur,2. the name ofthe medicinal product,

3. the composition ofthe medicinal productin accordance with 11

para. 1

sentence 1 no. 6 letter d ofthe Medicinal Products Act

4. the therapeutic indications,

5. the contra-indications,

6. the side effects,

7. specific precautions for use to the extentthey are required for

labelling thecontainers and outer packaging,

7a. formedicinal products thatmay only be prescribed by physicians

or dentists,

the marking prescription only,

(2) According to para. 1 no. 2, with respectto medicinal products that

contain only one

pharmaceutically active ingredient, the specification must be followed

bythe description ofthis component with the note: active

ingredient;this does not applyif a descriptionofthe active ingredientis in included in the specification according to

para. 1 no. 2.

(3) According to paragraphs 1 and 2, the specifications must

correspond with those that

are mandated for package inserts under 11 or 12 ofthe AMG. If

the specifications

mandated in 11 para. 1 sentence 1 no. 3 letters a and c and no. 5 of

the AMG cannot be

provided, theymay be omitted.(4) The specifications mandated under paragraph 1 must be set apart

and clearly

distinguished from other promotionalinformation and be clearly

legible.


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(5) Paragraphs 1 and 2 do not applyto reminders ofmedicinal

products. An

advertisementis considered a reminder ofmedicinal products if only

the description of a

medicinal product or additionallythe name, the company, the brandofthe

pharmaceutical entrepreneur orthe note: "active ingredient" are

exclusively advertised.

14 Red Hand Symbol

(1) For notifications of newly discovered, serious pharmaceutically

related hazards or for

other riskinformation thatmust reach the physician and/or pharmacist

directly whenaction is required to exclude the endangerment ofthe patientif

possible, the Red Hand

symbolmust be placed on both the envelopes and the letters with the

inscription Urgent

notice regarding a medicinal product All available media may be

used for sending a

"Red Hand" letter and, depending on the requirements, a

deliverability rate that covers as

many bases as possible may be employed. In especially urgent cases itmay also be

necessaryto disseminate these notices verbally, per fax or via public

appeals, e.g. via the

press, radio and television.

(2) Neither as a whole norin partmay a Red Handletter have the

character of

promotionalmailings or contain promotionalmessages. Other

scientific information,

advertisements or promotionalmailings may not have the Red Handsymbol attached

oridentified as an urgent notice.

Is it possible to advertise non-prescription medicines tothe general public? If so, what restrictions apply?


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Apart from some restrictions, non-prescription medicines maybe advertised to the general public. As a general rule, suchadvertisements relating to non-prescription products have tocomply with the general provisions for advertising, i.e. they may

not be misleading.

Furthermore, advertisements for medicinal products whetherfor non-prescription or prescription-only products have toprovide certain basic information relating to the product (seequestion 3.1). The information must be set apart and clearlydistinguished from the other promotional information and mustbe clearly legible. An advertisement for medicinal products inthe print media or on television must be clearly separated and

distinct from the editorial parts of these media. Advertisementsthat are directed to the general public must provide an invitationto seek the advice of a health professional and to read thepackaging leaflet, as follows: "For risks and side effects readthe package leaflet or ask your doctor or pharmacist".

However, advertising to the general public must not contain anyadvertising statements relating to (mostly severe) diseasesexplicitly mentioned in the HWG, including epidemics, tumourdiseases, diseases of the metabolic system and internalsecretion, diseases of the blood and blood-forming organs andorganic diseases. Furthermore, such advertisements to thegeneral public must not contain expert opinions, statementsthat the product is recommended, tested or used by healthprofessionals or certain pictorial representations.

It is important to note, however, that all restrictions onadvertising non-prescription medicines to the general public aslaid down in the HWG have to be interpreted in light of Directive2001/83/EC on the Community code relating to medicinalproducts for human use. According to a judgement of theEuropean Court of Justice (ECJ) of November 2007 (Case C-374/05 "Gintec"), the Directive 2001/83/EC brought aboutcomplete harmonisation in the field of advertising of medicinalproducts and lists expressly the cases in which Member States


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are authorised to adopt provisions departing from the rules laiddown by that Directive. Therefore, the restrictions contained inthe HWG shall not be interpreted as being more restrictive thanthe restrictions in the EC-Directive. For example, the ECJ ruled

that the prohibition on the use of statements from third parties(testimonials) as laid down in the HWG may not beinterpreted as an absolute and unconditional prohibition as theuse of third party statements is limited under the Directive2001/83/EC only by reason of their specific content or the typeof person making the statement.

In addition, an advertisement should serve only as a reminderof the medicinal product (Erinnerungswerbung) and need not

contain the basic information on the medicinal productmentioned above or the invitation to seek the advice of a healthprofessional.

U.K CODE OF CONDUCT FOR OTC:

Mechanisms for regulation of advertising ofnonprescription medicines

Different mechanisms can be used to ensure thatnonprescription medicine

advertisements are truthful and not misleading to consumers.Two dimensionsare of importance. Firstly, whether a pre-release or post-publicationsystem for advertisements is in place. For a pre-releasesystem, advertisementsare formally approved before they are released to the public.A post-publication system relies on a complaints procedurebeing appliedafter the event. The second dimension is who undertakes thetask of applyingthe regulatory process a government or independent body,industry, orsome combination of each of the interested parties. Of courseeven systems


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that rely solely on industry oversight procedures will usuallyhave somegovernment oversight or monitoring process remaining in place.Systems where the government has a strict pre-control over

advertisingare gradually disappearing because they tend to impair theefficiency andeffectiveness of advertising in its role of stimulator of the marketcompetition.Substantial delays meant higher operating costs for thecompaniesand also imposed an unnecessary workload on regulatoryagencies staff.

It is also difficult for government authorities to assess and judgeproposedadvertisements with technical consistency. The global trend isnow towardsself-regulatory or co-regulatory methods with government post-publicationsurveillance (i.e., taking action against violations rather thanpre-clearingthe advertisements)

Pre- or post-publication approvalA pre-clearance system for advertisements is carried out beforethey can bereleased. The pre-clearance may be carried out by thegovernment, by theindustry or by independent bodies. The pre-clearance may be

required bythe Law, or may be an industry voluntary procedure, as part oftheir codesof practice. For cultural and historical reasons different, butequally effective,approaches have evolved in different countries regarding pre-and postpublication


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controls on nonprescription medicines advertising.In Australia, it is a legal requirement that all advertisements fortherapeuticgoods directed to consumers, published or broadcast in

mainstream (designated)media must be approved before publication or broadcast.The Ministry for Health and Ageing has the responsibility forapprovingadvertisements, but the responsibility has been delegated toindustry tradeassociations (the Australia Self-Medication Industry, ASMI andComplementaryHealthcare Council, CHC) as part of a co-regulatory

arrangement.In the USA, the approval of the advertising material is givenprior topublication by the major broadcast TV networks who have legalclearancedepartments.In Canada, drug advertisements are reviewed and pre-clearedby IndependentAgencies. Consumer-directed advertising for self-care products

arepre-cleared by Advertising Standards Canada (ASC) andBroadcast ClearanceAdvisory (BCA).In some self-regulatory systems, such as in Britain, themanufacturer associationPAGB (the Proprietary Association of Great Britain) pre-approves theadvertisements. While member companies are always legally

responsible fortheir advertising, the pre-publication approval system aims tohelp membersensure that their consumer advertising complies with the legaland voluntary


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requirements. The review process usually also involvesrepresentativesof the advertising industry and others (Box 4).

Self-regulatory systems of advertising control

Self-regulation in the nonprescription medicine industry is thevoluntary useof agreed Codes of Practice by pharmaceutical companiesregarding promotionand advertising of medicines to the public. These codes arewritten andadopted by national associations of nonprescription medicineand self-caremanufacturers. Codes contain procedures for judgingcomplaints along withmeasures for non-compliance. Self-regulation works becausecompanies incompetition with each other are likely to be the most expert andsensitivecritics of their competitors advertising.

The pre-approval system of advertisingmaterial in Britain

3.4.1 PAGBs pre-publication approval of advertising materialshas helpedmembers achieve a high level of compliance with both statutoryand selfregulatoryrequirements.3.4.2 Specialist staff carry out the pre-publication approval ofadvertising materials.PAGB has access to independent medical and legal expertise

to adviseon evidence and matters of interpretation under the PAGBConsumer Code.3.4.3 The system of pre-publication approval is as follows:


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the member company, or agents working on behalf of themember company,conceive the advertising.the member company, or agents working on behalf of the

member company,submit the advertising to PAGB for approval.PAGB checks the advertisement against the rules in thePAGB Consumer Code,the Marketing Authorisation and any other regulation or code of

practicewhich applies to the specific medium for which theadvertisement is intended.Any queries over medical or legal claims are referred toPAGBs medical and/orlegal advisers.


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PAGB notifies the member company or agents working onbehalf of themember company of any changes required, or evidence whichis needed, before

the advertisement can be approved.once PAGB is satisfied that the advertisement complies withthe PAGB ConsumerCode, it is approved, subject to PAGBs Terms of Approval forAdvertisingand the company is notified.the advertisement can now be seen by the public.

Regulation of O.T.C in U.S.A:

Safeandeffec ve ove - e-counte (OTC) medicineseasily

availableto consume s withouta prescriptionplayavitalandcost-

effective roleinthenationshealthcaresystem. The marketing of

thesedrugsissubjectto strict oversightbytheU.S. Federal Trade

Commission (FTC) whichhasalonghistory ofenforcementagainst

improper OTC drugadvertising.

The Non-Prescription Drug Modernization Act of2007 (H.R. 4083/S.

2311), introducedby Representative Henry Waxman (D-Calif.) andSenator Edward Kennedy (D-Mass.) in October 2007, instead would

chargethe U.S. Foodand Drug Administration (FDA) with oversight

ofOTC medicineadvertising.

Congress, however, should rejectanyeffortto shift OTC advertising

oversightfrom the FTC to FDA. FDA, however, isanalready

overwhelmedagencythatdoesnothavethe resourcesto carry out

thisadded responsibility. Incontrast, the FTC isanactive regulator

with robustlegalauthorityandanestablishedinfrastructureforcontinuingitsvigorousenforcement ofOTC drugadvertising.

Thenumberstellthestoryover the pastdecade, the FTC has

initiated morethan 229 enforcementactionschallengingfalseand

misleadinghealthandsafetyclaimsfor products whoseclaims


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rangedfrom weight-lossto curingcancer. From April 2006 through

August 2007, the FTC initiated or resolved19 law enforcement

actionsinvolving 31 productsallegedly makingdeceptivehealth

claims.

TheNational Advertising Division (NAD) ofthe Council ofBetter

Business Bureaus (CBBB) also maintainsavigorousadvertising

oversight program thatfrequentlyadjudicateschallengesto OTC

drugadvertising. Between 2004 and 2007, the NAD adjudicated over

tenchallengesto advertisingclaimsfor OTC drugssuchas wart

removers, internalanalgesics, athletesfoottreatments, anti-itch

products, acnetreatments, andcoldandflu products.

Issues of concern for o.t.c brands:

Reverse switching in otc advertising:

There have been some markets where there have

been reverse switches, where the brand has gonefrom Rx to OTC and then the regulator has

reversed the switch. One example is Australia'sNational Drugs & Poisons Scheduling Committee

which unscheduled paediatric cough and cold

products and codeine combinations. Are thesebecause of safety concerns?

Often these reverse switches are for concerns otherthan safety. For example, pseudoephedrine has been

reverse switched not because it's an unsafe product but

because it can be reverse manufactured intoamphetamines. In fact, the New Zealand andAustralian police calculate that more crime is now

committed by people on amphetamines reversed

manufactured from pseudoephedrine than any otherdrug problem they have. So it has nothing to do with


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the safety profile of pseudoephedrine, in fact it's an

extremely safe an efficacious medication. It's a social

issue.

And this has been the case in other countries as well.In Mexico, there have episodes of the raw materials

being hijacked and in one recent case, the security

guards were murdered when a 70-kg consignment washijacked because its street value ran into millions of

dollars. So in many of the Latin American and Asian

markets, pseudoephedrine has gone behind thecounter. But it's nothing to do with the efficacy of the

medicine.

India too has seen the reverse switch of popular OTC

ingredients, dextromethorphan, due to drug abuseissues. The point here in India is that there are too fewrepresentations from the industry going up to the

authorities with the safety information. If you canreally back up your demand for an OTC switch withsafety data, rather that waging a verbal war with the

regulatory authorities, then it possible to get an Rx toOTC switch approved.

That's what happened with the emergencycontraceptive (EC) pills category. They were being

advertised because they got the OTC nod from theconcerned regulatory authorities. Then suddenlycertain sections took an objection to the advertising

asking that it be stopped. Rather than stopping the

advertising of such products, we have to becomeresponsible about educating the consumer in the right

manner about such products. In this case, we have totell the consumer clearly that EC pills are used in

emergencies, and are not for regular use. So it's how


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you say it and what the advertisement says that you

want to regulate, but not stopping the advertising.

You have to realise that reversing a switch is not going

to stop usage, people will still use the product. There'sa whole range of Rx products sold under the counter in

India, like a range of non-sedating histamines. But

what would you rather have: these products sold underthe counter without the correct POS education or

legitimising them through switch and then be done

much more safely. So in the rest of the world it actuallybelieved that Rx to OTC switches actually promote

public health.

Challenges for otc :

The OTC cash cow has attracted the attention of notjust pharma companies, even though pharma players

have traditionally dominated the segment owing to

their strong presence across the pharmacy channel.

Higher entry barriers and competitive pricing owing tothe large range of players in the segment (FMCG /

FMHG entities, large pharma companies, small genericfirms, etc) in this market and fragmented distribution

channels with insufficient reach in rural areas are

further challenges.

Competition will increase rather than decrease as in thefuture, pharma companies could also face some

competition from private label products introduced by

pharmacy chains like Apollo and Guardian that aresteadily growing their footprint across India.

From a communication perspective, out that most OTC

brands have in the past grown with excellent mass


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exposure strategies with adequate media support.

Though this holds true today as well, with fragmented

media and consumer attention, it is becomingincreasingly cost prohibitive for OTC companies to

create a high Share of Voice (SOV) on par with otherFMCG brands which are much bigger in size.

Therefore it is crucial that OTC companies invest inbrand building like other FMCG brands. The way to do

it, can be muti-pronged which begins with knowing the

consumers and segmenting them so that you can reachthem in a more targeted manner. Minimum media

wastage and therefore cost should be the mantra.

"OTC marketing differs from pure FMCG marketing as

there are many possibilities of doctors/chemistschanging course of therapy even in common ailmentsor supplements. Simultaneously it is important to

understand the role of the doctor and the chemist, asthey can wield a significant influence in creating apositive recommendation for the brand." She dubs this

the Rainbow Coalition strategy in OTC marketing.

Problemsin O.T.C :

One is the huge number of chemists that you have inIndia. The Relationship Compass Survey conducted by

CubeX showed that you have more than 700,000chemists so it's a highly fragmented market, with very

low penetration of chains (just a couple of thousand).Outlets are very small, compared to the chain stores in


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the rest of the world. So fragmentation in the chemist

sector is a major problem that the manufacturers have

to overcome.

It can be overcome but it requires very differentstrategies. It requires driving the brand through

advertising and the chemist will not advertise, that's

become very clear in this Survey. And this needs to besupported this effort with training at the Point of Sale

(POS).

Thenextstageise-learningand wefoundintheSurveythat only 40

percent ofthechemistsin Indiahaveacomputer onthe premises. As

thatincreases, wecanbeginto putininternetlearning programmes,

andthat'sthefuture

Case of banned O.T.C advertisement India:

The government of India has asked all the promoters of over-the-counter oral contraceptive pills to stop advertising it onmass media, like television.

Drug Controller General of India (DCGI) has issued an advisoryto all the marketers of oral emergency contraceptive pills (ECP)asking them not to advertise the product.

Since drug advertising is not permitted under the existing rule,we have sent an advisory to all pharmaceutical companiesmaking ECPs, asking them not to advertise their productsthrough mass media, reports said quoting the Health Ministrysources.

Although around 15 companies are now producing ECPs in thecountry, Piramal Healthcare, Morepen, and Mankind togethercontrol over 80 per cent share in the segment.

A Public Interest Litigation (PIL) has been filed in the AndhraPradesh High Court seeking to ban the sales of over-the-counter emergency contraceptive pills such as i-pill, Unwanted


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72 and Option 72 in India as they can lead to widespreadmisuse and dangerous consequences to the public.

Emergency contraceptive pills also known as `morning afterpills, which are used to prevent soon after sexual intercourse to

prevent pregnancy, are currently available in the Indian drugstores as OTC and they dont require a prescription from thephysician.

Citing scientific evidence from studies published in internationalpeer-reviewed journals, the PIL argues that the use of levonorgestrel will result in various side effects and seeks a ban onthe sale of i-pill, Unwanted 72 and Option 72 over the counter(OTC) s could result in serious consequences on the public.

The massive publicity campaign created by the promotional adson i-pill, Unwanted 72 and Option 72 and increasedaccessibility of these pills OTC in retail drug stores will lead tomisuse of the products by public, the PIL alleges.

Acting on the petition the High Court has send notices to theDrug Controller General of India (DCGI) asking him to providedetails about the marketing permission given to some of thepharma companies on the levo norgestrel products.

The promotional ads i-pill, Unwanted 72 and Option 72 aretemporarily banned from airing by DCGI following public outcryand has been left to DTAB for technical advice in this regard.

DTAB, the highest authority under the Union health ministry ontechnical matters concerning medicines, is yet to submit itsreport. But the ads have already reappeared on screen, reportssaid.

OTC sales of these pills could also promote unsafe sex among

younger generation and may result in the increase of HIV/AIDSand other sexually transmitted diseases, civil society groupsargued.

The national health regulator Drug Controller General of India(DCGI) had earlier this year withdrawn the permission toadvertise ECPs through print and electronic media as the ads


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did not convey the fact that the pills were to be consumed onlyin case of emergency.

But later, the Health Ministry had permitted it on condition thatsuch ads should make the consumer aware of the side-effects.

But recently the DCGI sent notices to three drug makers forshowing the ads without addressing the concerns raised by thegovernment.

The technical advisory body for drugs had also decided toframe guidelines on ads of ECPs following reports of side-effects in some cases due to indiscriminate use.


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Case .S.A: lenol eat issueaftermat . .C

advertisement:


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Branding strategies some common branding methods fornew o.t.c products:

- Brand name strategies: We need first to highlight that the

particularity of pharmaceutical brands is thatthey have, two names. The brand name and the moleculename. Themolecule name is present throughout the development processand will be theone used in scientific publications.

Chemical derived names: For example, Cipro for

Ciprofloxacin ( dependent on the chemical entity in the otc

product)

Therapy names: Procardia for patient suffering from heart

problems ( depends on what therapy that otc product is used

for example cardiac therapy)

Use or indication name: For example, we will find :Prilosec, Glucophage, Propulsid, Norvasc, Ventolin, Cardizem.There is

also a risk of imitation from the competition. ( depends on whatindication that otc product will be promoted or advertised)

Family name or drug class name: For example:Mevacor/Zocor. There is also the possibility of identifying anamethat is semi-descriptive of a drug class: Tolinase, Micronase

( depends on the active ingredient family name)

Corporate name: Sandimmune (Sandoz), Baycol andGlucobay (Bayer) ( on corporate name)

New invented name: For example: Zocor, Zantac


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PRODUCT BRANDING: PHARMA OTC MAJORLY

FOLLOWS PRODUCT BRANDING. EXAMPLE REVITAL,SUPRACTIVE

ENDORSED BRANDING:

REVITAL ENDORSED BY YURAJ SINGH.

UMBRELLA BRANDING:

UMBRELLA BRANDING RARE IN OTC PHRAMACEUTICAL

PRODUCTS VICKS .

PUBLIC RELATION/ CSR BRANDING:

OTROVIN OF NOVARTIS LETS GET DECONGEST AND

TYLENOL BY J&J

CORPORATE BRANDING:

"A decadeago the productbrand usedto bethestrongest point of

recallbut wehave observedagradual movetowardsassociation

withthecorporatebrandname. Pharmacompaniesandits products


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arenotconsumer goodsandthedemandfor most ofthem isneed-

basedso theemphasis onboththecorporateand product (identity)

isthat muchstronger"

EXAMPLE: CALCIUM SANDOZ

FMCG BRANDING in pharma OTC products:

Pharma otcbrandingisfollowing onthelines ofo.t.cbrandingand

advertisingtechniquesanlatesteample oftheadvertisement of

ranbaxys revitalendorsedbyyuvraj.singhanditsscoop

advertisementby piramals supractive, followingatrendlikethefmcgadvertisements.

Also the pharma otcbrandsarebrandedandadvertisedina waythat

theyare perceivedasfmcg (essentialfor daily use products)

Also otc pharmais relatingasimilar brandingstratergylikethefmcg

sector.

Brand extension and line extension given importance like that in fmcg:

Brand extension:

The FMCG strategy of taking an existing brand name and then extending itto other product categories has been tried on occasion within thepharmaceutical OTC sector (over the counter free from prescription) butvery limited success has been achieved. To some extent this strategy has25

worked counter to the training of one of the key influencers in the process,pharmacists. They fear the increasing chances of a dispensing mistake asa major argument to resist this type of brand tactic e.g. Panadol is

associated as a paracetamol brand, but adding aspirin components andchanging the brand name to a similar sounding brand would be potentiallydifficult. Many patients, who where for instance aware that they are aspirinallergic, would not spontaneously, check the constituents for such a wellknown paracetamol based brand.

Line extension:

This term is similar in pharmaceuticals and FMCG, this connotes an


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Example: otrovina Novartis otc product: onfacebook as

csrbranding

Also thetelivison mediaisinvadedinanewer waysby otc makers

like : pfizers gelusil mps moment ofthedayduringcwggames.

Andalso moviesbecomean oddalternativefor the otc phrama

productslike recent moviedabangsongfeaturingthebrandname

zandu balm from zandu pharmahasgivenboosting resultsfor zandu


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balm. This optionalso remainsasa outsideadvertising sourcefor

future ofthe pharma o.t.c products.

abstract asia pacific edited kunal

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