SAMI LABS is an Indian pioneer in the relatively new field of nutraceuticals
and has been manufacturing natural pharmaceuticals and chemical intermediates
in its own facilities in Karnataka since 1991.
addition to its own R & D centre and four manufacturing facilities,
Sami markets its products in the U.S. through its affiliate Sabinsa
Corporation and all natural products in a standardised form. These products
include Guggulsterone, Boswellin, Ursolic acid, Garcinia extract, Tetrahydrocurcumin,
Curcumin, Glucosamine HCl, Piperine from Black Pepper, Fenufibers from
Fenugreek, Forskholin from Coleus forskholii and Garlic Selenium along
with L-Selenomethionine. Sami and Sabinsa have been conducting IND's
for Gugulip and Boswellic acids in the U.S.
the year ended March 31, 2002, Sami Labs' turnover was Rs. 66 crores.
The turnover is expected to reach Rs. 150-200 crores by 2005.
efforts have been recognised by the Central Government in the form of
number of awards for export performance. Sami has seven U.S. patents
with 15 patents pending. These are mostly application patents.
Majeed, Managing Director, Sami Labs, in an interview with N. N. Sachitanand
said the major reason for success of Sami had been due to its efforts
to develop good documentation for safety and efficacy and for conducting
its clinical trials in the U.S. on American population that was crucial
in establishing its bonafides. Excerpts.
What are nutraceuticals?
Nutraceuticals encompass a large group of preventive and curative health
care ingredients that have been predominantly derived from long-standing
medical traditions such as Ayurveda, Tibetan, Chinese and Japanese medical
systems. Nutraceuticals are primarily obtained from plants especially
those with a well-established use as foodstuff. The blend of these pharmaceutical
and nutritional characteristics resulted in the name "Nutraceuticals,''
to denote the nutritional origins and the design moulded on pharmaceuticals,
that is, standardisation, efficacy and predictability of action.
nutraceuticals owe their beginnings to alternative medicine movement
and to people who recognised that health care especially in the U.S.,
obtained from physicians, pharmacists and other health professionals
needed to be supported by safe, effective cost effective and more accessible
is some confusion about the difference between herbal extracts, nutraceuticals
and ayurvedic drugs. Can you clarify?
extracts are products derived from herbs, that is, plants.
are derived from nutritional compounds having therapeutic value in contrast
to straightforward "Pharmaceuticals.'' Nutraceutical need not only
be derived only from plants. Even vitamins, minerals and some synthetic
compounds are classified as Nutraceuticals. Ayurvedic drugs not only
include plant-based products mentioned in Ayurveda, but also minerals
in the form of "Bhasmas'' and the like.
have been till now regarded as OTC products for general health purposes.
Are they now entering the area of prescribed medicines?
in the U.S. continue to be available as non-prescription dietary supplements.
In the mid-1980s, when they started, they were accepted as part of "alternative''
medicine; by mid-1990s, they were being spoken to as part of "complementary''
medicine; and by year 2000-01, they are part of the so-called "integrated''
medicine. They are recognised as: (a) safe; (b) as preventives; and
(c) useful in chronic disorders. The Allopathic physicians are beginning
to prescribe them as well now, although they do not require the USFDA
regulations at present.
many years old is the global nutraceutical industry, what is its present
size and projected rate of growth?
nutraceutical industry dates back to the 1980s and its present global
size is in the region of $100 to 125 billion. The leading market for
nutraceuticals is the U.S., with a turnover of about $29 billion. However,
other countries are also starting to promote nutraceuticals. The projected
rate of growth in the U.S. is about 15 per cent per annuam.
major companies such as Amway, Twin Labs, General Nutrition Centers
and Solgar Inc., which have pioneered the marketing of nutraceuticals
in the U.S. Because of the tremendous commercial success of these companies,
virtually every major pharmaceutical company has in the last two to
three years entered the nutraceutical business either by acquisition
of existing smaller companies or starting their own divisions for nutraceuticals.
These include pharma companies such as Johnson & Johnson, American
Home Products and Procter & Gamble. Also a number of cosmetic companies
such as Estee Lauder, Avon and Revlon have entered the market with "Cosmeceutical
products'' for skin and hair care.
India almost all major pharmaceutical companies have either entered
or are in the process of getting into this line of business with standardised
Ayurvedic products or nutraceutical/dietary supplements.
there any international standards for nutraceuticals? Do the manufacturers
have to get any approvals from watchdogs such as the USFDA or the Indian
Drug Controller before releasing their products in the market?
the moment, companies in the U.S. cannot make any therapeutic claims
on the label according to DSHEA (Dietary Supplement Health and Education
Act) which was passed by the U.S. Congress in 1994. This Act while promoting
the use of dietary supplements or nutraceuticals has tried to prevent
"tall'' claims by unscrupulous elements. Indian drug authorities
apparently have taken a similar stand. However, a number of "nutraceuticals''
are now being included in the official Pharmacopoeial compendiums for
their curative value. For example, Guggul for lowering cholesterol has
been included in the Indian Pharmacopoeia; L-Selenomethionine as a source
of `essential' selenium has been included in the U.S. Pharmacopoeia
and Glucosamine for arthritic pain is now being included in the U.S.
Pharmacopoeia. Also a large majority of the nutraceuticals find a place
in the European herbal/botanical compendium as botanical remedies.
your industry have to undertake mandatory multiphase clinical trials?
nutraceuticals have to establish their efficacy and safety like any
other health care product. There are no mandatory multiphase clinical
trials required. However, a company, which has conducted multiphase
and multi location clinical trials, has a distinct marketing edge. Safety
per se for these products is less of an issue because a number of them
have their origin in existing alternative systems of medicine or has
been used as food for many years.
are the major ailments that can be treated by nutraceutical products?
therapeutic areas (such as anti-arthritic, pain killers, cold and cough,
sleeping disorders, digestion, prevention of certain cancers, osteoporosis,
blood pressure, cholesterol, depression and diabetes) have been covered
by nutraceuticals. Newer ones are being found on a continuing basis.
It is believed that almost all ailments will be covered in the next
few years because one has to remember that synthetic drugs really did
not come into being till about 1940 and till that time most systems
of medicine (for example, Ayurveda) has had plants and minerals identified
for almost all diseases.
is tremendous resistance here by NGOs to natural products and age-old
remedies being given patents. What is your position?
position is that age-old remedies where the knowledge for their use
was in the public domain, should not be given patents. However, new
applications of known natural products can be patented for those "applications''
but they must not be given "product'' patents. The potential for
patenting newer applications of some of the traditional remedies is
tremendous. Companies which obtain these patents will definitely benefit.
the end consumer, are nutraceuticals a cheaper alternative to pharma
products or ayurvedic formulations?
the end consumer, nutraceuticals do provide more affordable alternatives.
One must remember that one of the main reasons that nutraceuticals developed
originally in early 1980s was that the high cost of healthcare/pharma
industry had become prohibitive in the U.S.
widespread is the backward linkage system, like tissue culture and contract
farming in the nutraceutical industry?
this country, it is a relatively new industry. Backward linkage like
contract farming is inevitable because the wild resources from where
plants are being collected now are limited. Companies in this business
would have to evolve more adaptable varieties and varieties suitable
for cultivation in order to survive in this business. It is a function
of time that backward linkages will be established as indeed they have
established in the U.S. Example: Cultivation of saw palmetto in Florida.
the nutraceutical industry lend itself to small-scale operations like
the pharma formulations sector?
but small-scale units will have to find niche markets. For example,
a company may specialise in two or three nutraceuticals based with availability
of the raw material in its area of operations.
are the natural advantages that India has for the nutraceutical industry?
What is the size and structure of the Indian industry?
is home to almost all kinds of plants ranging from tropical, sub-tropical
and temperate zone plants. Also the advantage of knowledge based remedies
gives India tremendous leads in finding newer applications (because
of Ayurveda). Indian Scientists have been active in this field for decades;
pay off period is here now!
is relatively a new market. The size of the Indian industry is likely
to reach about Rs. 1,000-1,200 crores in the next four years.
mentioned earlier, all major pharma players are in the process of entering
this market. This will become particularly important post 2005 when
WTO patent regime will be implemented in the country. For natural products
there will be obviously no product patents. Scale of operation may give
advantage to existing pharma players because of their marketing and
distribution channels are already in place.
level of exports from India is still small, perhaps less than Rs. 750
crores if one excludes Psyllium. The major importing countries are the
U.S., Europe and Japan.
are the steps to be taken to make India a big player in this industry?
can become a big player in this industry if it develops clinical documentation
and scientific basis to support claims of safety and efficacy. Companies
such as Sami have succeeded because they have developed the required
clinical documentation and have done clinical studies in the U.S. thus
developing credibility. This will become even more important if India
wants to become a major player.
about competition from China?
exports of nutraceuticals are huge. Chinese expatriate population do
form a major section of consumers but it is the belief of general American
population in alternative system of medicine that has driven the Chinese
exports. India with its well established Ayurvedic system has an opportunity
because existing Indian exports are not even 5-7 per cent of exports
in value terms when compared with Chinese.