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www.expresspharmaonline.com FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS
1-15 November 2007  
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Recent times have witnessed the rise of high end cosmetics, boasting of clinical trials and guaranteed results. Simultaneously, some pharma companies are promoting their personal care products in a way to ensure proactive, prevention based purchase, than the usual problem-solution route. Welcome to the world of cosmeceuticals. Nandini Patwardhan discovers

What is it about soap bars? Dettol on one hand, Dove on the other and Niko yet on the other hand. For starters, they are soaps, main task being cleaning the skin. Going beyond this superficial similarity, one might observe that all of these belong to different segments of the same product-soap bars. While Dove is a beauty soap (cosmetic) and Niko a medicated bar, Dettol comes under the upcoming category of cosmeceuticals. "In soap as a category, Niko is a dermatological soap, dove soap will be cosmetic; but suppose you take Dettol or lifebuoy—these are cosmeceuticals," explain Dr Raja B Smarta, Managing Founder of the Mumbai-based consulting firm, Interlink.

This is the land of cosmeceuticals for you. Experts opine that cosmeceuticals are topical cosmetic-pharmaceutical hybrids, which are intended to enhance the users beauty through ingredients that provide additional health-related function or benefit. This means that though they are applied topically as cosmetics, they contain certain ingredients that influence the skin's biological functions.

Cosmeceuticals FAQs

"The core competency of any pharma company is prescription medicines. Certain companies tie up with cosmetic players on providing inputs on cosmeceuticals. However, the strategy for pharma companies is to wait and watch"

- Utkarsh Palnitkar
Partner-Transaction Advisory Services
Leader - Policy & Investment Advisory Services
Ernst&Young

There exists confusion regarding the status of 'cosmeceuticals'. Although there is no legal class called cosmeceuticals, this term has found application and recognition to designate the products at the borderline between cosmetics and pharmaceuticals. "Cosmeceuticals are not subject to FDA review and the Federal Food, Drug and Cosmetic Act does not recognise the term itself. It is also often difficult for consumers to determine whether 'claims' about the actions or efficacies of cosmeceuticals are in fact valid, unless the product has been approved by the FDA or equivalent agency, explains Utkarsh Palnitkar, Partner, Transaction Advisory Services Leader-Policy and Investment Advisory Services, Industry Leader-Health Sciences, Ernst & Young. "Some countries have the classes of products that fall between the two categories of cosmetics and drugs—for example, Japan has 'Quasi-drugs', Thailand has 'controlled cosmetics' and Hong Kong has 'cosmetic-type drugs.' The regulations of cosmeceuticals have not been harmonised between the USA, European, Asian and other countries," he adds.

Not many studies are available in the market on this segment. Cosmeceu-ticals are not well mapped as a segment and all evidence pertaining to market size is anecdotal in nature. Still, the industry estimates that the market for cosmeceutical products in the global market is projected to grow by 8.5 percent ($5.1 billion) by end 2007. India, with only two percent share in the global market, has a long way to go. Also, cosmeceuticals (from a pharmaceutical industry perspective) in value terms are miniscule in India and are yet to pick up. The sector is more driven by the cosmetic companies with inputs from pharma players.

In India, currently, it is the derma category in this segment, which is in news. "This is because mainly in pharma, there are two segments that are growing very well-dermatology and opthalmalogy. So from the ORG IMS, or any other analysis. All analytics tell us, tell every company, look enter this segment," reveals Smarta.

Another reason for the derma category picking up, in general, is the environmental challenges like global warming that have cropped up in the past few years. The direct impact of these issues can be observed through increase in dermatological infections. Other possible reasons for a growth of this segment can be the changing consumer preferences and rise in the disposable incomes.

Testing times

Elder Pharmaceutical too has tied up with renowned expert Shehnaaz Hussain for the Fairever range of cosmetic products. "The core competency of any pharma company is prescription medicines and every company proclaims so," states Palnitkar. "Certain companies tie up with cosmetic players on providing inputs on cosmeceuticals, like the example mentioned above. However, the strategy on cosmeceuticals for pharma companies is to wait and watch," he adds.

L'oreal cosmetics has set up its cosmeceutical department, which is christened as the active cosmetics department or dermocosmetics known as Vichy Laboratories. Vichy products are said to combine the results of drugs and the pleasure of cosmetics, hence the name 'Dermocosmetics'. The offerings from this stable are recommended by dermatologists and available across pharmacies only. They also have in place their product efficacy and results proven by clinical testing in hospitals and in conjunction with dermatologists, states their communication.

However, currently, there are no regulations or guidelines that govern the clinical trials undertaken by these products. But companies do mention that they are in accordance with the guidelines laid down for the regular pharma products. "The claims made about drugs are subject to high scrutiny by the Food and Drug Administration (FDA) review and approval process, but cosmetics are not subject to mandatory FDA review," states Palnitkar. "The USFDA is yet to come up with a comprehensive pathway for the cosmeceuticals segment. Indian regulatory authorities are also in the process to map out the sector and put in place guidelines," adds Smarta.

Crystal gazing

According to Palnitkar, the global trend in the cosmetic industry is towards developing 'medicinally' active cosmetics, and in the pharmaceutical industry, it is skewed to 'cosmetically' oriented medicinal products as part of a current 'life-style' ideology.

"The future promises increasingly sophisticated formulations for cosmetics and skin care products. Cosmetic companies are finding ways to deliver small dose ingredients that do not require medical regulations and to introduce steroids and hormones into lip balms, which would result in production of cosmeceu-ticals that could help to improve body mass, nail, and hair growth," he signs off.

nandini.p@expressindia.com

Dispelling Myths

Many make the mistake of classifying botox as a cosmeceutical. But the fact is, according to the company, that botox is a serious pharmaceutical product. Raju Nagi, Director, Sales, Botox India, chats with Nandini Patwardhan about botox

Why do you say that botox is not a cosmeceutical?

We cannot look at botox as a pure cosmeceutical in the sense that most cosmeceuticals would either be OTC products or would be products that patients can self administer. Botox is a very serious pharmaceutical product that needs to be administered by the trained physician. Indication wise, we are in the cosmetics market, but the cosmeceutical market per se is not the point we are not looking at that.

How is botox positioned in India?

At the moment, if you look at botox today worldwide, bulk of the business comes in from cosmeceutical applications. In India though, bulk of the market is actually from therapeutic indications. Therapeutic indications include movement disorders, spasticity (cerebral palsy in children is a big indication). Therefore, in India, at the moment, botox is like a speciality pharmaceutical product. As far as the cosmetic angle is concerned, that is taking care of the hyperkinetic lines (that is wrinkles for you and me), the market here is still in a nascent stage and we need to understand the insights better here.

How will you describe your consumer group in India?

Look at the typical Indian consumer vis-à-vis the typical European, or the American. In Europe and America, even the masses have caught on to botox, as sensitivity towards how you look is so important. That sensitivity is still not here. If you look at the markers from here, you will see that primarily the personal care category in the country is largely driven by bar soap sales, as compared to the developed part of the world, where hygiene sales are mainly driven by liquid soaps. Now these are pointing to the fact that issues that are mass issues in the West have still not caught on. Therefore, the issues like sensitivity about facial aesthetics are still in the nascent stage for us.

The main consumers for the cosmetics market in India would be SEC A+ consumers—people who are aware of the offerings, mostly celebrities who are involved with performing arts and who have to look good—or the SEC A+++ kind of consumers. These consumers will possibly have disposable incomes of US $25,000 and above, or an income of Rs 10 lakh and above, and who consult doctors for suggestions and advice on whether they should or should not use botox.

But for botox, the real market is people like you and me, and that would basically be the upper middle class. And the upper middle class is an area where one needs to tread carefully to ensure that the basics are addressed first. They are the guys, who are going to be more educated and who will have more questions, issues like perceptions, and misconceptions will come from this very consumer group. This is the real market we are working on.

What has driven acceptance of botox in the country?

Part of the acceptance comes from awareness. If awareness about the product is not there, then obviously, the way the product is going to be perceived will be different from what should be. And there will also be myths and misconceptions. So our focus is to spread awareness about the product and to ensure that these myths and misconceptions are dealt with. This is because in a product category like botox, which has to be administered by a trained doctor, there is a fear of negative publicity if the doctors are not trained well to administer the same. We also take a lot of care to ensure that the doctors who administer botox to the consumers get absolutely trained, as to how to use the product, which muscle groups to inject in? The last thing we want is doctors not being trained enough to administer the product, or they doing so in the wrong way.

How has it been for botox in India?

We received the first approval from the Drug Controller's office for therapeutic indications in 1994 and for cosmetic indications (which is for facial lines), in 2006.

From 1994-2006, therapeutic indications were where the bulk of company effort was concentrated. We were working closely with neuro-physicians, because they were the key customers for botox for therapeutic indications. After receiving the approval for cosmetic indications in 2006, we actually started working on the cosmetic front and today we are working closely with doctors like dermatologists (cosmetic dermatologists), aesthetic plastic surgeons, in terms of teaching them basics of botox and primarily how botox has to be used, its advantages, benefits etc.

What about clinical trials for Botox?

Our approvals are based on the clinical trials that we have carried out, because botox is a special pharmaceutical product. We have multi-centre trials that go across various locations in the world simultaneously. These are exactly the same clinical trials as mandated by USFDA. At botox, research efforts are still going on, because when we talk of botox, we talk of a portfolio of products within one product. This is because the product can be used for something as normal as facial aesthetics, and also for something as serious as movement disorders and spasticity.

nandini.p@expressindia.com

 

 


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