Wednesday, October 10, 2007

Soft power and a single herbal product license

The herbal market picture

The herbal market along with the Indian healthcare market is looking up. Growth is the catch all word in healthcare today.

In fact, this 2004 report from The Times of India states:The Indian herbal health care segment seems to have swallowed a vitamin pill. The segment grew at a rate of 12 per cent last year, and there is no immediate sign of the momentum slowing down, with an expected growth rate of 20 per cent this year. The domestic herbal market has now crossed the Rs 5,000 crore mark, and is set to reach further heights this year. Herbal exports from India is worth Rs 450 crore, whereas even a decade back the amount was barely Rs 100 crore. This may not be a huge sum when compared to the Chinese herbal exports market which is worth Rs 2,000 crore; but the sheer potential of the Indian herbal companies should make people sit up and take notice.

The attractive growth of the domestic herbal market is reinforced by a global herbal trend as per World Health Organization (WHO):THE green consumer is coming of age. The demand for medicinal plants is increasing everyday and the World Health Organisation (WHO) has projected that the global herbal market will grow to $5 trillion by 2050 from the current level of $62 billion.

Generating prescriptions for herbals

In India the doctors are the most important opinion builders for pharma and healthcare products.

According to marketers, Indian consumers have preconceived notions on brands, advertisements and people. When models wearing white coat are shown in ads, consumers attach a positive connotation that adds to the credibility of brand preposition. Mothers often listen in rapt attention when a neighborhood doctor suggests Hindustan Lever’s (HLL) Huggies diapers for bed wetting babies. HLL’s Lifebuoy Liquid and Reckitt Benkiser’s surface care brand Lysol say it all with a ‘doctor’ by their side. The doctor is a way of assuring the mother (in case of Horlicks and Complan). Marketers always want an endorser, be it celebrities, or authority figures such as doctors and teachers. It kind of becomes instructive for the functional benefits of the product category. “
- from the Economic Times dated 12.2.2007, p.no. 6

Revital from Ranbaxy is marketed with the Rainbow Coalition Product Promotional plan, in which, Revital is promoted to both doctors and end-consumers. Revital, containing Chinese ginseng, vitamins and minerals is categorized as a nutritional or dietary supplement, and thus, gets the support of all specialties of doctors (allopaths, ayurveds, etc). Had it been classified as an Ayurvedic product, the prescriber base would have got limited, and business results would be muted.

It is important to open the use of herbals, herbomineralvitamin formulations, and herbominerals to all medical practitioners by issuing a single herbal or herbomineralvitamin or herbomineral product license and not through separate categorizations as Ayurvedic, Siddha or Unani products. The complete data of whether the product is Ayurvedic, or Unani or Siddha, can be collected by the AYUSH department for records, but the license and label should simply mention as an herbal or herbomineral or herbomineralvitamin product. There is a need to go beyond the Ayurvedic, Siddha, and Unani licensing regimes – they only add to the herbal confusion.

The present licensing regimes as Ayurvedic etc, strengthens the defensiveness of allopaths (who form the bulk of the Indian prescriber market), and they resist from prescribing some of these medicines. However, a herbal product like standardized Centella asiatica extract from Roche (for blood vessel problems like varicose veins) or silymarin (German herbal product for liver disorders) or the Gingko biloba extract from German Remedies are categorized or labeled as allopathic products, and hence prescribed by allopaths. The objection from potential allopathic prescribers (who are the bulk of the prescribers in India) is not for the herbal actives used in the pharma product, but for the words An Ayurvedic Proprietary Medicine or A Sidda Proprietary Medicine.

It is important to present the native Indian pharma product to potential prescribers in a way that is welcome and generates confidence on the safety and efficacy of the product, and one way of doing this is by abolishing labeling as Ayurvedic or Siddha or Unani and labeling such products simply as Herbal or Herbomineral or Herbomineralvitamin. In that sense, Revital from Ranbaxy containing Chinese ginseng, vitamins and minerals, is a dietary or nutritional supplement, and this is a neutral labeling as it is neither Ayurvedic or Siddha or Unani. Hence, Revital enjoys a fund of confidence from all types of prescribers in India.

At stake here, is the soft power of India

The word soft power was coined by Joseph Nye, a distinguished professor of Harvard. The soft power of a country rests primarily on three resources: its culture (in places where it is attractive to others), its political values (when it lives up to them at home and abroad), and its foreign policies (when they are seen as legitimate and having moral authority.)

Soft power is a great product and service differentiator. Even the giants of global Pharma industry cannot match the way Kerala serves the world through Ayurveda (soft power component here is Ayurveda). In fact, the solidity and depth of success of companies like The Himalaya Drug Company comes from the fact that they have banked on the soft power of India.

So let the Govt., throw open the use of herbals to a broader audience (which would include allopaths – who form the bulk of the prescriber segment in India), and build the clinical experience for these soft power Indian products in modern parameters. Lack of clinical data in modern terms should not cause a loss of market opportunity for India. At stake is the soft power of India, the cultural history of India, and a slice of the past that is intrinsically Indian. In case of basmati rice patent case, we were reactive in taking care of Indian interest; in the neem patent case we scraped through. The business world however, has no mercy and keeps profits at the forefront. Let us observe, for a businessman, everything is fair in love, war, and business. (Sorry, can’t help, but think of Iraq war here). Being proactive and assertive is a wiser approach to defend and strengthen the soft power of India.

Today wars of a different type are on. It is a soft power war, and battles are fought in the marketplace with brands. Business interests drive and influence Govt. and military action in today’s world. The era of brand colonization is on. Today, Dyanora TV, EC TV, Crown TV, Weston TV, which were top TV brands of India at one time are not even in human memory for many in India. No wonder, they say public memory is short. Similarly, in the cola market Thums Up, Campa Cola etc are nowhere to be seen; and Coca Cola and Pepsi are now becoming a part of the Indian culture, psyche, and marketplace.

The herbal actives of Indian heritage will come back through allopathic field in a different form for eg., rauvolfia alkaloids (reserpine), vinca alkaloids (vincristine and vinblastin), and Taxol.

Pharma companies are not interested in any ‘pathies’ like allopathy, or any other branch of medicine. It is the marketability, corporate responsibility, patient interest, and top line and bottom line interests that matter to pharma companies. The main point is shareholder and stakeholder interests of the pharma company. For eg., consider the following brands in India of foreign (non-Indian) MNCs:

The interesting case of Calcium Sandoz


Of late, have you picked up a box of Calcium Sandoz? The label reads as follows:

Novartis
KHATIKA CURNA
Calcium Sandoz 250
Each chewable uncoated tablet contains:
Khatika Curna 625 mg
Nimbukamlam Shushkam 25 mg

This is a Novartis product. This multinational company was at the epicenter of the Glivec patent case. As per this link http://www.netdoctor.co.uk/medicines/100000428.html Calcium Sandoz contains calcium glubonate and calcium lactobionate in UK. In India the picture is as follows:

The historic product - Calcium Sandoz that had Calcium Carbonate now has something called Khatika Curna and Nimbukamlam and is A Proprietary Ayurvedic Medicine. Probably, Khatika Curna is Calcium carbonate and Nimbukamalam is Vit. D3. But type in Khatika Curna and Nimbukamlam in to http://www.google.co.in/ you get nothing. In fact, you get as follows:

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Your search - Khatika Curna and Nimbukamlam - did not match any documents. Suggestions:
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Please click here too: http://www.google.co.in/search?hl=en&q=Khatika+Curna+and+Nimbukamlam&btnG=Search&meta=

This brand case is that of a silent metamorphosis from an allopathic product to an Ayurvedic proprietary medicine. What are the new features, benefits, and problems of the new active ingredients in Calcium Sandoz? So what does the 250 in the brand name stand for? Earlier it meant that each tablet offered 250 mg of elemental calcium. Is it possible to claim accurately 250 mg of elemental calcium in an Ayurvedic product? Is an Ayurvedic manufacturing process followed for Calcium Sandoz? Khatika Curna and nimbukamlam – from where are they sourced? What is the qualitative and quantitative Ayurvedic assay techniques used for the above product, with respect to Vitamin D3 and elemental calcium? Ayurvedic products are manufactured as per Bhavaprakasha nighantu etc. So which reference does this label follow? These aspects need to be looked into and not swept under the carpet.

This link on the official website of Novartis, http://www.novartis.co.in/products/product_otc_impact.asp?Sid=2 describes the product Calcium Sandoz but does not use the words Khatika Curna and Nimbukamlam. Why? May be the webpage is not updated. Calcium is very well marketed OTC as a FMHG. May be the Ayurvedic avatar of Calcium Sandoz helped it go OTC and become a FMHG.

What about Iodex?

This age old product comes from GSK Consumer division. GSK is world leader MNC. Iodex too is an AYURVEDIC PROPRIETARY MEDICINE. When launched by Eskayef it was an allopathic product. It changed its licensing and affiliation sometime in 90s to Ayurvedic. Puzzling to note how the switch over of a pharma brand from one stream of medicine to another is easy.

If you click here: http://www.gsk-ch.in/Iodex.aspx the web page does not give details of composition or even a hint of its Ayurvedic profile. But the Crocin web page http://www.gsk-ch.in/crocin.aspx gives very good details of its composition.

And is NPPA casting a Nelson’s eye on these brands?

The above pharma examples are unique and point to the challenges in the regulatory environment in India with the fast growth of Indian healthcare market.

Functional foods and regulatory challenges

With the healthcare boom, rise of the functional foods market and herbal market, regulatory challenges are many. For eg., Saffola Gold is positioned as a cooking oil medium that helps reduce blood cholesterol levels. Is it safe for my daughter 61/2 years of age to eat puris three times a week cooked in Saffola Gold for the rest of her life? Or should my wife use Saffola Gold while cooking for the aged members in my family, and regular Saffola for the younger ones? These questions and many others will crop up when the functional foods market gains steam. There is a thin line between medical claims and health claims. To address such public concerns the USA has a dietary supplement health regulation act.

Regulatory changes in USA

Come Nov 2007, there will be debate in the USA to start a new category of pharma products called behind-the-counter medicines. This means pharmacies in USA will have over-the-counter medicines, prescription products, and probably a new categorization for some medicines called behind-the-counter medicines. This new category of products will not require a prescription for purchase similar to the over-the-counter pharma products. It must be noted here that the merit of India’s pharma market is the fact that it is an OTX market, which USA is now trying to make happen through a new behind-the-counter medicines category.

A single herbal or herbomineral or herbovitaminmineral product license

The answer to knotty problems as above, lies in a single herbal or herbomineral or herbomineralvitamin product license. Not Ayurvedic, not allopathic, not siddha, not unani and what have you…only a single simple license that makes the product amenable to prescriptions from all doctors (whether allopathic, ayurvedic, unani…). And then unleash the potential of herbal soft power of India for the world.

This is my 50th blogpost - yes I have completed a half a century of blogposts. Please do read all other blogposts by clicking on older posts wherever required.

5 comments:

DR. RANGESH said...

Chiplunkarji, Please accept our HEARTY CONGRATULATIONS for your remarkable achievement in reaching Golden jubilee number of the blogposts. Indeed an accomplishment to rejoice with.
You have indeed made an elaborate analysis of the current scenario regarding the herbal products in India. Although at the outset I agree with your view, but the reason why the MNC’s branded products are turning to change the licence to APM is not understood. There may be many reasons and couple of them are that the regulatory control for this class of products are not as stringent as in the case of allopathic drugs (although many of these products are also known to have their spurious look-alikes / counterparts which are rampant and yet could not be controlled at large) and there are no known methods for assay and quality control etc.
There are some corrections in the post to be read as. The Nimbukamlam Shushkam is Citric Acid dry powder and not Vit.D3. Khatika is Chalk which is found in nature of a soft, white, porous sedimentary rock, a form of limestone composed of the mineral Calcite – a carbonate mineral of calcium (CaCO3). The use of 625 mg of the compound would yield 250 mg of elemental calcium. This formula is seen in the new product called CALCIUM SANDOZ – SoftChew which is different from the product Sandocal Chew 250 whose composition is given with Calcium Carbonate and Vit D3 125 IU. This product is marketed through the doctor prescription route. But astonishingly there are two sets of the same product by this MNC which are both in prescription route as well as OTC. They are Calcium Sandoz Growth which has Iron and Zinc and Calcium Sandoz Strength. This proves that the SoftChew the so called APM product is an exclusive brand than the existing range.
Since Khatika and Nimbukamlam are Sanskrit names hence there are no possibilities of the search engine to have any hits. This is the blind spot in the whole effort. The popularity of these names due to them being Sanskrit / Ayurveda in nature there are no takers. This is unfortunate.
Although your view of having uniform licensing format as herbal is welcome but would probably undermine the source of the combination/concept/thoughts. What is better needed is the education and empowering efforts on Ayurveda and its armamentarium from natural sources to the world at large. I think there is a need of strong branding of Ayurveda on scientific platform and make the world understand it better without ambiguity. When the IMA and other organizations are fighting on banning the cross prescription and not allowing the medical pluralism to benefit the suffering, how can single simple license would authorize allopathic doctors to prescribe? There is a need for better understanding of these systems and mutual admiration is the need of the hour for the benefit of the world at large.

sunil said...

Dear Drji:
Many thanks for your kind compliments and more importantly for your enlightening comments. It has added clarification to the blogpost that I have just put up. These scholarly comments from your end have provided clarity to the blogpost. Its an honor to have your comments and please do visit my blog regularly.

Regarding your contention that Ayurvedic identity in licensing is required, is definitely what I expected as your point of view - AFTER ALL I DO KNOW YOUR DEDICATION TO THE CAUSE OF AYURVEDA. In part, the reason I put up the common license point is to stir up some debate. Churning of ideas and thoughts would normally bring out better solutions.

Thks and Thnks once again - please I value your best wishes and blessings a lot.

Design for communication said...

The article was really informative even for a laymen like me. I stumbled across your blog while searching for the ingredient "khatika" and "parad". I had some doubts regarding the use of Zandu's Parad Tablet. It is used for preventing raw pulses, rice etc from lice and insects.It is easily available in a medical store. I googled and came to know that parad is mercury and is very dangerous for human consumption.I am confused now as my mother has been using it in raw rice and dals effectively for years now.It does seem to kill the rice lice but is it safe for us to use? Please suggest.

Dnz said...

Nice article, but i'm confused !! I just bought a 100 tablet pack & am wondering if I was cheated. I honestly don't care if the product if allopatheic or ayurvedic or vegetarian or non vegetarian ( Some people claim bone powder is present in this product). All I care about is, does the product contain calcium or not ? The presence of calcium is what I bought this & if calcium is not present, I'd just return the product back !!

Angela Navejas said...

Nice Info! There are many people who are interested to have an ayurvedic treatment with full satisfaction.

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