Japan promises to be one of the most lucrative generic markets in the world. Between 2005 and 2008, the Japanese generics market grew at a CAGR of around 7.5% to register ¥ 333 Billion (US$ 3.5 Billion) in revenue, according to “Japanese Generic Market Forecast to 2013”, a new research report by RNCOS – an industry research firm. Currently, generics accounts for just 5 per cent of the Japanese drug market but the market size is likely to grow many folds. The government officials with a view to bring down healthcare costs are encouraging doctors to prescribe generics to the patients.

Other factors such as a large number of patent expiries and the largely un-penetrated nature of the market are also contributing towards the market growth. Japan’s per capita expenditure on healthcare is comparable to that of many western countries. Moreover, the country’s share of total health expenditure dedicated to drugs is very high. The government therefore has come up with reform measures and programmes to support the generics sales and investments made by the global giants in this sector, the report said.

The Japanese Ministry of Health, for example, announced a programme two years ago to increase generic drugs market share from 17% to more than 30% by 2012. Besides, the government introduced a generic substitution system in which pharmacists are allowed to substitute generic drugs if doctors do not specify that a brand name drug is to be dispensed.

Despite this huge opportunity, the generics are facing a number of other challenges. Generic drugs are still regarded as cheap, low quality alternatives of branded drugs in Japan. Both physicians and patients are skeptical about their safety and efficacy. A number of awareness and educational programmes, however, are expected to increase the awareness of generic drugs in the future. At present, the generics market in Japan is dominated by domestic manufacturers. The top six manufacturers accounting for 56% of the total market in 2007. But opening up of the market and introduction of a number of generic-friendly reforms is attracting a number of foreign players in the market.

Ranbaxy Laboratories, now a subsidiary of Daiichi Sankyo, was among the first Indian company to foray into Japan. Ranbaxy set up a 50:50 joint venture with a local company, Nippon Chemiphar, in 2005. Ranbaxy has launched five products in the Japanese market, led by voglibose, clarithromycin and amlodipine, in therapeutic segments such as diabetes, anti-infectives, anti-allergics, anti-fungals and hypotensives. Of this, voglibose and clarithromycin are among the top-selling generic brands in Japan. In 2007, Ranbaxy earned nearly $30 million revenue from the Japanese market. But following its acquisition by Daiichi, Ranbaxy stopped the JV with Nippon, in 2008.

Lupin is another Indian player that has been keen get into the generic space in Japan. In October 2007, Lupin acquired Kyowa Pharmaceuticals to enter Japan. Sales of Kyowa have grown over 21 per cent during the past year and it ranks as the eighth-largest generic player in Japan, according to Lupin.

The Ahmedabad-based Zydus Cadila entered the Japanese market in 2006 with the acquisition of Nippon Universal Pharmaceutical. Nippon has a network of more than 4,000 hospitals and clinics across the country. Zydus plans to launch at least five to six products every year in Japan.

Similarly, Dishman Pharmaceuticals and Chemicals, another Ahmedabad-based company, entered Japan through a joint venture, Dishman Japan, in association with Azzurro Corporation, a 30-year-old marketing firm.

Several other Indian generic players including Biocon and Dr Reddy’s have set their eyes on this high-value market.

So, the generic makers see a huge opportunity to make investments into the country as the global financial crisis is not reaping enough margins to the generic manufacturers in the European countries. Generic companies can set high prices and reap high margins in less intense competition and the unexploited nature of the Japanese generics market.

Ayurveda is considered to be a form of complementary and alternative medicine (CAM) within the western world, where several of its methods, such as the use of herbs, massage, and Yoga as exercise or alternative medicine, are applied on their own as a form of CAM treatment.

Ayurveda is grounded in a metaphysics of the ‘five [great] Elements’ ([महा] पञ्चभूत; earth, water, fire, air and ether)—all of which compose the Universe, including the human body. Chyle (called Rasa dhatu), blood (called Rakta dhatu), flesh (called Mamsa dhatu), fat (called Medha dhatu), bone (called Asthi dhatu), marrow (called Majja dhatu), and semen (called Shukra dhatu) or female reproductive tissue (called Artava dhatu) are held to be the seven primary constituent elements (सप्तधातु) of the body. Ayurveda stresses a balance of three substances: vata (wind/spirit/air), pitta (bile) and kapha (phlegm), each representing divine forces. According to Ayurveda, these three regulatory principles—Doshas (त्रिदोश)—are important. Traditional beliefs hold that humans possess a unique constellation of Doshas. In Ayurveda, the human body perceives attributes of experiences as 20 Guna (गुण, meaning qualities). Surgery and surgical instruments are employed. It is believed that building a healthy metabolic system, attaining good digestion, and proper excretion leads to vitality. Ayurveda also focuses on exercise, yoga, meditation, and massage. Thus, body, mind, and spirit/consciousness need to be addressed both individually and in unison for health to ensue.

The practice of Panchakarma (पंचकर्म‌) is believed to eliminate toxic elements from the body. Eight disciplines of Ayurveda treatment, called Ashtanga (अष्टांग), are given below:

1. Surgery (Shalya-chikitsa)
2. Treatment of diseases above the clavicle (Salakyam)
3. Internal medicine (Kaaya-chikitsa)
4. Demonic possession (Bhuta vidya): Ayurveda believes in demonic intervention and—as a form of traditional medicine—identifies a number of ways to counter the supposed effect of these interferences. Bhuta vidya has been called psychiatry.
5. Paediatrics (Kaumarabhrtyam)
6. Toxicology (Agadatantram)
7. Prevention and building immunity (rasayanam)
8. Aphrodisiacs (Vajikaranam)

History

AyurVeda is referenced in the literature from the Vedic period between 4000-2000 B.C.E. The four Vedas; Brahmanas, Upanishads, Mahabharata and the Puranas refer to concepts of AyurVeda . Rig Veda contains Indira, Agni and Soma relating to Vata, Pita and Kapha, the three doshas (biological humors) of AyurVeda. Yajur Veda introduces the AyurVedic ideas of the organs and dhatus (tissues). Sama Veda contains chants related to health of the body, mind and spirit while Atharva Veda contains reference to herbs, disease treatments and systematic knowledge of Ayurveda. Since Atharva Veda contains a lot of references to AyurVeda, sometimes AyurVeda is considered to be an Upaveda or branch of AyurVeda. The Brahmanas mention the five pranas (life-force) and the seven dhatus in detail. The Upanishads teach the mental and spiritual aspect of AyurVeda. The Mahabharata discusses doshas and their effects on health and diseases. The Puranas describe the patron deity of AyurVeda, Lord Dhanvantari, as ‘King of Kashi.’

At the end of the Vedic Period, between 2000-300 B.C., AyurVedic knowledge was preserved, reformulated and systemically arranged and compiled into Samhitas . The three authentic Samhitas that we have today are Charaka Samhita, Sushruta Samhita and Ashtanga Hridaya. These three Samhitas are collectively called Brihattrayi. Charaka Samhita and Sushruta Samhita were written during this period while Ashtanga Hridaya was written around 600 AD.

Current Status

Within India

In 1970, the Indian Medical Central Council Act was passed by the Parliament of India, which aims to standardize qualifications for Ayurveda and provide accredited institutions for its study and research. In India, over 100 colleges offer degrees in traditional Ayurvedic medicine. The Indian government supports research and teaching in Ayurveda through many channels—both at the national and state levels—and helps institutionalize traditional medicine so that it can be studied in major towns and cities.[35] The state-sponsored Central Council for Research in Ayurveda and Siddha (CCRAS) is the apex institution for promotion of traditional medicine in India.[36] The studies conducted by this institution encompass clinical, drug, literary, and family welfare research.

Many clinics are run by professionals who qualify from these institutes—both in the urban and the rural areas. Mukherjee & Wahile cite World Health Organization statistics to demonstrate the popularity of traditional medicine, on which a significant number of the world’s population depends for primary health care. In Sri Lanka the number of traditional Ayurveda practitioners is greater than trained modern medicine professionals. The manufacture and marketing of Ayurvedic medicine has been commercially successful for several pharmaceutical companies. Old manufacturing companies such as Vaipa Pharmaceutical Works,Arya Vaidya Sala, Arya Vaidya Pharmacy, IMIS Pharmaceuticals, Dabur, Baidyanath have maintained the classical range, while also patenting certain own formulations, such as Gyncocalm, Jeevani, Eosinophal, Dabur Pancharishta. Similarly, MNCs like Hindustan Unilever Limited, in collaboration with Arya Vaidya Pharmacy, has been promoting its chain of Ayurvedic Massage Therapy Centres in the Brand name of [Ayush Therapy Centre],with two of the major centers located at Kalyan and Vashi.

Outside India

Ayurveda gained recognition in the Western world as medical scholars, notably , Frank John Ninivaggi MD of Yale University School of Medicine, researched and outlined its various postulates in one major textbook form suitable to Western academic science. In the United States of America, the NIH NCCAM expends some of its $123 million budget on Ayurvedic medicine research. In addition, the National Institute of Ayurvedic Medicine, established by Dr. Scott Gerson, is an example of a research institute that has carried out research into Ayurvedic practices. Gerson has published part of his work on the antifungal activities of certain Ayurvedic plants in academic journals. The postulates and history of Ayurveda have also been outlined by foreign scholars—such as Dominik Wujastyk in the United Kingdom.

Journal

A variety of peer reviewed journals focus on the topic of ayurvedic medicine, including the Theoretical and Experimental Journal of Ayurveda and Siddha (TEJAS; published between 1981 and 2008 as Ancient Science of Life), the Journal of Research & Education in Indian Medicine (JREIM), AYU (published quarterly) and The International Journal for Ayurveda Research (published quarterly).

Patents

In December 1993, the University of Mississippi Medical Center had a patent issued to them by United States Patent and Trademark Office on the use of turmeric for healing. The patent was contested by India’s industrial research organization, Council for Scientific and Industrial Research (C.S.I.R), on the grounds that traditional Ayurvedic practitioners were already aware of the healing properties of the substance and have been for centuries, making this patent a case of bio-piracy. The Government of India had become involved in promoting traditional medicine by 1997.

“In India the government became involved in traditional drug production when the Central Drug Research Institute patented two new drugs from ancient Ayurvedic formulas. One, a mixture of black pepper, long pepper, and ginger, allows for the dosage of the antibiotic rifampicin to be halved in the treatment of tuberculosis and other mycobacterial infections. The other is a memory tonic produced from the traditional plant called brahmi. Overseas patenting of turmeric and products of the neem tree caused controversy in India and other nations. In August the U.S. Patent and Trademark Office canceled a U.S. patent on the wound-healing properties of turmeric when the Indian government proved that records had existed for this use for centuries.”