Overview: With an average operating margin of 20.

2 percent for the leading companies between 2005 and 2008, and a market size of $450 billion in 2008.Speaking specifically of the Indian market, she says an upturn of 10.7 percent made it one of the fastest-growing countries in terms of OTCs .The Indian OTC market is estimated to be about Rs. 7434 crore in 2008 ($ 1.8 billion).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 percent CAGR 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, antismoking aids, etc collectively account for over Rs 3000 crore.

Paradigm shift in otc: The early birds who adopted an OTC-focussed strategy in the Indian pharma market are already reaping rich rewards. Ranbaxy was one of the first domestic companies to foray into the OTC segment in 2002,

through a separate business division called Ranbaxy Global Consumer Healthcare. The division started with four products Revital, Garlic Pearls, Pepfiz and Gesdyp all of which were prescription drugs turned into OTC products. In 2008, the consumer healthcare unit of Ranbaxy clocked sales of $44 million, growing at 25 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 Ranbaxys top-selling products, even outpacing some of its top selling prescription brands. Nair points out that from January to July in 2009, Revital earned Rs 66 crore for Ranbaxy as compared Rs 63 crore for Mox, its highestselling antibiotic. Other successful OTC products include Sugar Free from Zydus Cadila, which earns about Rs 80-85 crore annually, compared to hypertension drug Aten (Rs 70 crore). The emergency contraceptive i-Pill, launched by Cipla 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 aided by) its slightly controversial positioning. In fact, Piramal Healthcare considered i-Pill such an attractive buy 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 OTC category in the country following their switch to OTC in 2006.

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 to customer (DTC) world, the consumer makes his or her own choice by getting exposed to and influenced by advertising and other media. An informed consumer, who is predominantly present in the urban markets, is exposed to advertising or could be exposed to a friend'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 from interacting with a prescription drug where the influencer is the doctor. The OTC product will need to be 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 dealing in OTC products is that, unlike the traditional pharma model of pushing generic products by selling to doctors, the OTC segment is more analogous to the FMCG 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 the strength of FMCG companies (e.g. Procter & Gamble (Vicks), GSK Consumer (Eno fruit salt)) and is a skill that will need to be rapidly developed by pharma companies."

Pharma companies therefore have to learn to think like their FMCG counterparts. These include focussing on improving penetration through traditional FMCG channels, like grocery stores, which will also help pharma companies make the transition from selling to doctors to direct contact with consumers. Today, OTC preparations for cough and cold, antiallergic, balms, or a low dosage of some safe non-steroidal antiinflammatory drugs (NSAIDs) are also stocked with grocers / 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 margin pressures. Paras Pharmaceuticals, for instance, has introduced 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 and penetration 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 help to create a demand for the product, distribution ensures that the consumer interacts with the brand and may take a purchase decision without the consumer having to run to 10 or 15 shops to locate the healthcare brand. Similarly, engaging with the trade will be extremely important because these business partners can make a huge difference to the success or failure of a brand."

Growth rate of otc segments:

Growth rates of different OTC categories Sales in US$mn (MSP) Major categories India Vitamins, Minerals & Supplements 2009 09/08/10 CAGR CAGR Yr Yr 14/09 19/14 10.2 10.8

1813.4 10.7

634.5

8.8

10.2

Gastrointestinals 332.6 Cough, Cold & Allergy Analgesics 318.1 258.7

10.4 7.8 15.8 11.3 38.9

10.3 9.7 10.3 11.9 20.8

10.7 9.9 10.6 12.7 13.6

Dermatologicals 236.5 Lifestyle OTCs 33.2

Data Source : Nicholas Halls DB6 2010*

Top brands in otc globally:

Top 10 global OTC brands Leading brands 2008 2009 Grth'09/08 (Sales 90965.1 95193.2 4.6 $Milllion) Global 1 2 3 4 5 6 7 8 9 Tylenol Vicks Halls Lipovitan Aspirin Advil Centrum Nature Made Nicorette 1449.9 871.5 792.3 854.5 796.1 716.3 695.2 577 525.8 514 1452.5 880.9 830.6 812.9 798.5 722.1 693 639.1 525 488.1 0.2 1.1 4.8 -4.9 0.3 0.8 -0.3 10.8 -0.2 -5

10 Claritin

Data Source : Nicholas Halls DB6 2010*

Top 10 Indian OTC brands Leading brands (Sales $Million) India 1 2 3 4 5 6 7 8 9

2008 2009 Grth'09/08 1638.9 1813.4 10.7

Dabur 75.8 Chyawanprash Vicks Boroplus Revital Zandu Balm Dettol Liv.52 Becosules Hajmola 72.4 29 25.4 28.4 23.7 25 22.7 20.2 17.6

84.5 81.9 32.9 30.7 30.5 26.4 25.8 24.9 21.2 20.7

11.5 13.1 13.4 20.7 7.6 11.2 3.4 10.1 4.9 18.2

10 Iodex

Data Source : Nicholas Halls DB6 2010*

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

OTC Advertisement in India Regulations: The Drug & Magic Remedies (Objectionable Advertisement) Act & Rules mentions a list of ailments for which no advertising is permitted. It also prohibits false or misleading advertisements

whi h, di tly or i directly, gi e fal e im ressions regarding the true character of the drug, make false claims, or are otherwise false or misleading in any particular respect The DCGIs office -in collaboration with the Organi ati n of Pharmaceutical Producers of India (OPPI) - has released a Voluntary Code on OTC Advertising which is being followed by all OPPI member companies. There is also an OPPI Code of Pharmaceutical Marketing 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 of prescription drugs although industry practice is not to 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 for its 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. if therapeutic effectiveness or effects are attributed to prescriptiononly medicinal products that they do not possess, 2. if the impression is falsely created that a) success can be expected with certainty, b) that no harmful effects will be experienced if the medicinal product is taken as directed or over a long period of time,

c) the advertisement is not being produced for purposes of competition, 3. if untrue or misleading statements are made a) with regard to the composition or characteristics of drugs, medicinal products, devices or other media or the manner of procedures or treatments or b) about the person, prior training, qualifications or successes of the manufacturer, inventor or the persons performing for them or who have performed for them. (3) When determining whether withholding a fact is misleading, its suitability for influencing the prescribing decision of the health professionals addressed must particularly be taken into account. (4) Advertising must be supported with sufficient scientific documentation and may not contradict the specifications in the technical information. This applies especially to promotional messages that refer to certain advantages, qualities or characteristics of a medicinal product or active ingredients. Promotional messages about side effects must also 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. If members of the 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 the corresponding scientific documentation is available. (6) Sweeping statements that a medicinal product has no side effects, toxic hazards or risk

of addiction or dependency are prohibited. Statements that certain side effects, toxichazards or risks involving addiction or dependency have not yet been identified are permissible only if they are supported with sufficient scientific documentation. (7) Drugs may be designated as "new" only within one year after they 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 company must be designed so that they cannot be mistaken for independent editorial statements. (3) With respect to publications by third parties about medicinal products and their use which are financed by a company in their entirety or in part, care must be taken to ensure that these publications very clearly state that they are financed by the company. 9 Prohibition against advertising non-approved medicinal products and nonapproved indications Advertising medicinal products that require pharmaceutical approval is permissible only if they have been approved. An advertisement that refers to therapeutic applications or forms of administration, which are not covered by the requirement for approval is prohibited. 10 Mandatory specifications (1) Each advertisement for medicinal products within the meaning of 2 para. 1 or para.

2 no. 1 of the Medicinal Products Act must contain the following specifications: 1. the name or the company and the registered office of the pharmaceutical entrepreneur, 2. the name of the medicinal product, 3. the composition of the medicinal product in accordance with 11 para. 1 sentence 1 no. 6 letter d of the Medicinal Products Act 4. the therapeutic indications, 5. the contra-indications, 6. the side effects, 7. specific precautions for use to the extent they are required for labelling the containers and outer packaging, 7a. for medicinal products that may only be prescribed by physicians or dentists, the marking prescription only, (2) According to para. 1 no. 2, with respect to medicinal products that contain only one pharmaceutically active ingredient, the specification must be followed by the description of this component with the note: active ingredient; this does not apply if a description of the active ingredient is 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 of the 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, they may be omitted. (4) The specifications mandated under paragraph 1 must be set apart and clearly distinguished from other promotional information and be clearly legible.

(5) Paragraphs 1 and 2 do not apply to reminders of medicinal products. An advertisement is considered a reminder of medicinal products if only the description of a medicinal product or additionally the name, the company, the brand of the pharmaceutical entrepreneur or the note: "active ingredient" are exclusively advertised.

14 Red Hand Symbol (1) For notifications of newly discovered, serious pharmaceutically related hazards or for other risk information that must reach the physician and/or pharmacist directly when action is required to exclude the endangerment of the patient if possible, the Red Hand symbol must 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 it may also be necessary to disseminate these notices verbally, per fax or via public appeals, e.g. via the press, radio and television. (2) Neither as a whole nor in part may a Red Hand letter have the character of promotional mailings or contain promotional messages. Other scientific information, advertisements or promotional mailings may not have the Red Hand symbol attached or identified as an urgent notice.
Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?

Apart from some restrictions, non-prescription medicines may be advertised to the general public. As a general rule, such advertisements relating to non-prescription products have to comply with the general provisions for advertising, i.e. they may not be misleading. Furthermore, advertisements for medicinal products whether for non-prescription or prescription-only products have to provide certain basic information relating to the product (see question 3.1). The information must be set apart and clearly distinguished from the other promotional information and must be clearly legible. An advertisement for medicinal products in the print media or on television must be clearly separated and distinct from the editorial parts of these media. Advertisements that are directed to the general public must provide an invitation to seek the advice of a health professional and to read the packaging leaflet, as follows: "For risks and side effects read the package leaflet or ask your doctor or pharmacist". However, advertising to the general public must not contain any advertising statements relating to (mostly severe) diseases explicitly mentioned in the HWG, including epidemics, tumour diseases, diseases of the metabolic system and internal secretion, diseases of the blood and blood-forming organs and organic diseases. Furthermore, such advertisements to the general public must not contain expert opinions, statements that the product is recommended, tested or used by health professionals or certain pictorial representations. It is important to note, however, that all restrictions on advertising non-prescription medicines to the general public as laid down in the HWG have to be interpreted in light of Directive 2001/83/EC on the Community code relating to medicinal products for human use. According to a judgement of the European Court of Justice (ECJ) of November 2007 (Case C374/05 "Gintec"), the Directive 2001/83/EC brought about complete harmonisation in the field of advertising of medicinal products and lists expressly the cases in which Member States

are authorised to adopt provisions departing from the rules laid down by that Directive. Therefore, the restrictions contained in the HWG shall not be interpreted as being more restrictive than the 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 be interpreted as an absolute and unconditional prohibition as the use of third party statements is limited under the Directive 2001/83/EC only by reason of their specific content or the type of person making the statement. In addition, an advertisement should serve only as a reminder of the medicinal product (Erinnerungswerbung) and need not contain the basic information on the medicinal product mentioned above or the invitation to seek the advice of a health professional.
U.K CODE OF CONDUCT FOR OTC: Mechanisms for regulation of advertising of nonprescription medicines Different mechanisms can be used to ensure that nonprescription medicine advertisements are truthful and not misleading to consumers. Two dimensions are of importance. Firstly, whether a pre-release or postpublication system for advertisements is in place. For a pre-release system, advertisements are formally approved before they are released to the public. A post-publication system relies on a complaints procedure being applied after the event. The second dimension is who undertakes the task of applying the regulatory process a government or independent body, industry, or some combination of each of the interested parties. Of course even systems

that rely solely on industry oversight procedures will usually have some government oversight or monitoring process remaining in place. Systems where the government has a strict pre-control over advertising are gradually disappearing because they tend to impair the efficiency and effectiveness of advertising in its role of stimulator of the market competition. Substantial delays meant higher operating costs for the companies and also imposed an unnecessary workload on regulatory agencies staff. It is also difficult for government authorities to assess and judge proposed advertisements with technical consistency. The global trend is now towards self-regulatory or co-regulatory methods with government postpublication surveillance (i.e., taking action against violations rather than pre-clearing the advertisements)

Pre- or post-publication approval A pre-clearance system for advertisements is carried out before they can be released. The pre-clearance may be carried out by the government, by the industry or by independent bodies. The pre-clearance may be required by the Law, or may be an industry voluntary procedure, as part of their codes of practice. For cultural and historical reasons different, but equally effective, approaches have evolved in different countries regarding preand postpublication

controls on nonprescription medicines advertising. In Australia, it is a legal requirement that all advertisements for therapeutic goods 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 for approving advertisements, but the responsibility has been delegated to industry trade associations (the Australia Self-Medication Industry, ASMI and Complementary Healthcare Council, CHC) as part of a co-regulatory arrangement. In the USA, the approval of the advertising material is given prior to publication by the major broadcast TV networks who have legal clearance departments. In Canada, drug advertisements are reviewed and pre-cleared by Independent Agencies. Consumer-directed advertising for self-care products are pre-cleared by Advertising Standards Canada (ASC) and Broadcast Clearance Advisory (BCA). In some self-regulatory systems, such as in Britain, the manufacturer association PAGB (the Proprietary Association of Great Britain) preapproves the advertisements. While member companies are always legally responsible for their advertising, the pre-publication approval system aims to help members ensure that their consumer advertising complies with the legal and voluntary

requirements. The review process usually also involves representatives of the advertising industry and others (Box 4).
Self-regulatory systems of advertising control Self-regulation in the nonprescription medicine industry is the voluntary use of agreed Codes of Practice by pharmaceutical companies regarding promotion and advertising of medicines to the public. These codes are written and adopted by national associations of nonprescription medicine and self-care manufacturers. Codes contain procedures for judging complaints along with measures for non-compliance. Self-regulation works because companies in competition with each other are likely to be the most expert and sensitive critics of their competitors advertising. The pre-approval system of advertising material in Britain 3.4.1 PAGBs pre-publication approval of advertising materials has helped members achieve a high level of compliance with both statutory and selfregulatory requirements. 3.4.2 Specialist staff carry out the pre-publication approval of advertising materials. PAGB has access to independent medical and legal expertise to advise on evidence and matters of interpretation under the PAGB Consumer Code. 3.4.3 The system of pre-publication approval is as follows:

 the member company, or agents working on behalf of the member 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 the PAGB Consumer Code, the Marketing Authorisation and any other regulation or code of practice which applies to the specific medium for which the advertisement is intended. Any queries over medical or legal claims are referred to PAGBs medical and/or legal advisers.

 PAGB notifies the member company or agents working on behalf of the member company of any changes required, or evidence which is needed, before the advertisement can be approved. once PAGB is satisfied that the advertisement complies with the PAGB Consumer Code, it is approved, subject to PAGBs Terms of Approval for Advertising and the company is notified. the advertisement can now be seen by the public.

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

Safe and effec ve ove - e-counte (OTC) medicines easily available to consume s without a prescription play a vital and costeffective role in the nation s healthcare system. The marketing of these drugs is subject to strict oversight by the U.S. Federal Trade Commission (FTC) which has a long history of enforcement against improper OTC drug advertising. The Non-Prescription Drug Modernization Act of 2007 (H.R. 4083/S. 2311), introduced by Representative Henry Waxman (D-Calif.) and Senator Edward Kennedy (D-Mass.) in October 2007, instead would charge the U.S. Food and Drug Administration (FDA) with oversight of OTC medicine advertising. Congress, however, should reject any effort to shift OTC advertising oversight from the FTC to FDA. FDA, however, is an already overwhelmed agency that does not have the resources to carry out this added responsibility. In contrast, the FTC is an active regulator with robust legal authority and an established infrastructure for continuing its vigorous enforcement of OTC drug advertising. The numbers tell the story over the past decade, the FTC has initiated more than 229 enforcement actions challenging false and misleading health and safety claims for products whose claims

ranged from weight-loss to curing cancer. From April 2006 through August 2007, the FTC initiated or resolved 19 law enforcement actions involving 31 products allegedly making deceptive health claims. The National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) also maintains a vigorous advertising oversight program that frequently adjudicates challenges to OTC drug advertising. Between 2004 and 2007, the NAD adjudicated over ten challenges to advertising claims for OTC drugs such as wart removers, internal analgesics, athlete s foot treatments, anti-itch products, acne treatments, and cold and flu 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 gone from Rx to OTC and then the regulator has reversed the switch. One example is Australia's National Drugs & Poisons Scheduling Committee which unscheduled paediatric cough and cold products and codeine combinations. Are these because of safety concerns? Often these reverse switches are for concerns other than safety. For example, pseudoephedrine has been reverse switched not because it's an unsafe product but because it can be reverse manufactured into amphetamines. In fact, the New Zealand and Australian police calculate that more crime is now committed by people on amphetamines reversed manufactured from pseudoephedrine than any other drug problem they have. So it has nothing to do with

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 was hijacked because its street value ran into millions of dollars. So in many of the Latin American and Asian markets, pseudoephedrine has gone behind the counter. 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 abuse issues. The point here in India is that there are too few representations from the industry going up to the authorities with the safety information. If you can really back up your demand for an OTC switch with safety data, rather that waging a verbal war with the regulatory authorities, then it possible to get an Rx to OTC switch approved. That's what happened with the emergency contraceptive (EC) pills category. They were being advertised because they got the OTC nod from the concerned regulatory authorities. Then suddenly certain sections took an objection to the advertising asking that it be stopped. Rather than stopping the advertising of such products, we have to become responsible about educating the consumer in the right manner about such products. In this case, we have to tell the consumer clearly that EC pills are used in emergencies, and are not for regular use. So it's how

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's a 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 under the 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 actually believed that Rx to OTC switches actually promote public health.

Challenges for otc : The OTC cash cow has attracted the attention of not just 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 to the large range of players in the segment (FMCG / FMHG entities, large pharma companies, small generic firms, 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 the future, pharma companies could also face some competition from private label products introduced by pharmacy chains like Apollo and Guardian that are steadily growing their footprint across India. From a communication perspective, out that most OTC brands have in the past grown with excellent mass

exposure strategies with adequate media support. Though this holds true today as well, with fragmented media and consumer attention, it is becoming increasingly cost prohibitive for OTC companies to create a high Share of Voice (SOV) on par with other FMCG brands which are much bigger in size. Therefore it is crucial that OTC companies invest in brand 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 reach them 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/chemists changing course of therapy even in common ailments or supplements. Simultaneously it is important to understand the role of the doctor and the chemist, as they can wield a significant influence in creating a positive recommendation for the brand." She dubs this the Rainbow Coalition strategy in OTC marketing.

Problems in O.T.C : One is the huge number of chemists that you have in India. The Relationship Compass Survey conducted by CubeX showed that you have more than 700,000 chemists 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

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 different strategies. 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 be supported this effort with training at the Point of Sale (POS). The next stage is e-learning and we found in the Survey that only 40 percent of the chemists in India have a computer on the premises. As that increases, we can begin to put in internet learning programmes, and that's the future

Case of banned O.T.C advertisement India: The government of India has asked all the promoters of overthe-counter oral contraceptive pills to stop advertising it on mass media, like television. Drug Controller General of India (DCGI) has issued an advisory to 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 companies making ECPs, asking them not to advertise their products through mass media, reports said quoting the Health Ministry sources. Although around 15 companies are now producing ECPs in the country, Piramal Healthcare, Morepen, and Mankind together control over 80 per cent share in the segment. A Public Interest Litigation (PIL) has been filed in the Andhra Pradesh High Court seeking to ban the sales of over-thecounter emergency contraceptive pills such as i-pill, Unwanted

72 and Option 72 in India as they can lead to widespread misuse and dangerous consequences to the public. Emergency contraceptive pills also known as `morning after pills, which are used to prevent soon after sexual intercourse to prevent pregnancy, are currently available in the Indian drug stores as OTC and they dont require a prescription from the physician. Citing scientific evidence from studies published in international peer-reviewed journals, the PIL argues that the use of levo norgestrel will result in various side effects and seeks a ban on the 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 ads on i-pill, Unwanted 72 and Option 72 and increased accessibility of these pills OTC in retail drug stores will lead to misuse of the products by public, the PIL alleges. Acting on the petition the High Court has send notices to the Drug Controller General of India (DCGI) asking him to provide details about the marketing permission given to some of the pharma companies on the levo norgestrel products. The promotional ads i-pill, Unwanted 72 and Option 72 are temporarily banned from airing by DCGI following public outcry and has been left to DTAB for technical advice in this regard. DTAB, the highest authority under the Union health ministry on technical matters concerning medicines, is yet to submit its report. But the ads have already reappeared on screen, reports said. OTC sales of these pills could also promote unsafe sex among younger generation and may result in the increase of HIV/AIDS and other sexually transmitted diseases, civil society groups argued. The national health regulator Drug Controller General of India (DCGI) had earlier this year withdrawn the permission to advertise ECPs through print and electronic media as the ads

did not convey the fact that the pills were to be consumed only in case of emergency. But later, the Health Ministry had permitted it on condition that such ads should make the consumer aware of the side-effects. But recently the DCGI sent notices to three drug makers for showing the ads without addressing the concerns raised by the government. The technical advisory body for drugs had also decided to frame guidelines on ads of ECPs following reports of sideeffects in some cases due to indiscriminate use.

Case .S.A: lenol eat issue aftermat advertisement:

. .C

Branding strategies some common branding methods for new o.t.c products: - Brand name strategies: We need first to highlight that the particularity of pharmaceutical brands is that they have, two names. The brand name and the molecule name. The molecule name is present throughout the development process and will be the one 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 what indication 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 a name that is semi-descriptive of a drug class: Tolinase, Micronase

( depends on the active ingredient family name)

Corporate name: Sandimmune (Sandoz), Baycol and Glucobay (Bayer) ( on corporate name) New invented name: For example: Zocor, Zantac

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 decade ago the product brand used to be the strongest point of recall but we have observed a gradual move towards association with the corporate brand name. Pharma companies and its products

are not consumer goods and the demand for most of them is needbased so the emphasis on both the corporate and product (identity) is that much stronger" EXAMPLE: CALCIUM SANDOZ

FMCG BRANDING in pharma OTC products: Pharma otc branding is following on the lines of o.t.c branding and advertising techniques an latest eample of the advertisement of ranbaxy s revital endorsed by yuvraj.singh and its scoop advertisement by piramal s supractive, following a trend like the fmcg advertisements. Also the pharma otc brands are branded and advertised in a way that they are perceived as fmcg (essential for daily use products) Also otc pharma is relating a similar branding stratergy like the fmcg 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 it to other product categories has been tried on occasion within the pharmaceutical OTC sector (over the counter free from prescription) but very limited success has been achieved. To some extent this strategy has 25 worked counter to the training of one of the key influencers in the process, pharmacists. They fear the increasing chances of a dispensing mistake as a major argument to resist this type of brand tactic e.g. Panadol is associated as a paracetamol brand, but addi ng aspirin components and changing the brand name to a similar sounding brand would be potentially difficult. Many patients, who where for instance aware that they are aspirin allergic, would not spontaneously, check the constituents for such a well known paracetamol based brand. Line extension: This term is similar in pharmaceuticals and FMCG, this connotes an

original brand and the later reformulation of it into new dosage forms. This tactic sometimes allows pricing flexibility but more often improves th e competitive dynamics a number of years after the original launch. These new dosage forms tend to allow administration to different patient types e.g. an oral solution can greatly ease the difficulty of administration of 27 large oral dosage forms to the elderly or paediatric populations. Another example constitutes the intravenous forms (IV), which can provide rapid loading of the product in the patients blood stream in the intensive care setting. Even tablet development can have an impact e.g. melt tabl ets can provide an acceptable taste mask and ease swallowing of large tablets as well as increasing the chances of compliance with a particular regimen. Reducing the frequency of administration can be highly successful also e.g. allowing the patient to take the product only once a day vs perhaps twice or three times previously. The consequences of extending existing brand names are much more complex in the pharmaceutical industry than in FMCG. There is always the risk of confusion and therefore misuse of drugs. The extension of existing brand names is therefore limited in this industry. However, if the industry leverages more the corporate name as an umbrella strategy, pharmaceutical will be more fully in line wit h the brand extension concept.
Co-branding: Co-branding is defined as industrial alliances that are visible by the mentioning of two brand names. All alliances do not lead necessarily to the mentioning of two names (Kpaferer 2001). In the pharmaceutical industry, due to the fragmented nature of the market place, we have seen more co-R&D development or co-marketing of products than in the FMCG sector e.g. despite its heritage with Innovace (Renitec in the US) MSD and its co-marketing partner were never as successful with Zestril and Carace as with the original.

FUTURE TRENDS IN OTC BRANDING: Social media sites on internet have created a new platform for the o.t.c products. branding for csr activities or public relations on the social networking sites is a newest trend amongst the pharma otc companies

Example: otrovin a Novartis otc product: on facebook as csrbranding

Also the telivison media is invaded in a newer ways by otc makers like : pfizer s gelusil mps moment of the day during cwg games. And also movies become an odd alternative for the otc phrama products like recent movie dabang song featuring the brand name zandu balm from zandu pharma has given boosting results for zandu

balm. This option also remains as a outside advertising source for future of the pharma o.t.c products.