Old Cures, Modern Medicines

The demand for herbal drugs is growing rapidly. But manufacturers will have to clinically validate their claims to penetrate both the domestic and overseas markets.

Last year, the ministry of health set up a department of Indigenous Systems of Medicine in Delhi. It was the first step towards co-ordinated research into herbal drugs. Besides, the Department of Science and Technology (DST) and the Council of Industrial and Scientific Research have instituted a research programme. Herbal drugs major Zandu Pharmaceutical Works Ltd is participating in this venture to examine the clinical claims of some herbal drugs. The DST is spending Rs 1.3 crore on the three-year project.

 

Understandably, companies are investing in R&D as a growing segment of the Indian population is looking at alternative cures. These include traditional systems of medicine like Ayurveda, Unani and Siddhi.

There are an estimated 6000 players in the Rs. 1,000 crore herbal drug industry. The market was chugging along at two per cent five years ago. Demand for herbal products has seen it leapfrog to 10-15 per cent over the last three years.

Pain-relievers, balms and medicines for upper respiratory tract disorders like Procter & Gambles Vicks, Hamdards Joshina and Daburs Honitus and Madhuvani have been doing brisk business. Digestives like Hajmola, Amritdhara and Pudin Hara and relievers of rheumatic and arthritic ailments are big ticket items. Herb-mineral combinations are also making a mark in the market, mostly in the form of rejuvenators or revitalisers like 303, Spy and Vita-X.

Prescription drugs are not as high profile as their OTC counterparts. A recent Supreme Court ruling makes it mandatory for a doctor to prescribe medicines only in his area of specialisation. However, as industry sources reveal, a lot of doctors get round this ruling by suggesting herbal medicines for certain disorders. A typical case is Himalya Drugss Liv 52, which through historical usage has become a kind of generic cure for liver ailments.

A major hurdle for herbal players is mass acceptance. For none of the herbal drugs strictly qualify as medicinal drugs. These are systems that have evolved through experience, not experiment, says a scientist in a premier research organisation. Curative claims now need validation in modern scientific terminology, but this is an expensive and long-term proposition.

Some of the herbal drug companies are now focusing on this. According to Dr. K M Parikh, president, The Zandu Pharmaceutical Works Ltd, the Rs 76.35 crore company has been investing two per cent of its turnover on R&D to ensure product quality. It has also promoted a non-profit body, the Zandu Foundation for Health Care, to augment the supplies of raw materials of a standard quality and clinically evaluate the benefits of some herbal products.

Dabur, the largest drug major with an estimated turnover of Rs 700 crore for March 1997, set up an All India Sales Board two years ago, with medical representatives. This lends credibility in marketing the brands to ayurvedic practitioners around the country.

The Rs 100 crore Hamdard, a major player in the Unani segment, is maintaining its edge by highlighting its difference with the Ayurvedic tradition. The difference, though, is not so much in the composition of drugs as the method of treatment

All the big players believe that a lot leaves to be desired on the export scene. The Middle-Eastern countries, USA, Canada and Europe constitute Indias main export markets for herbal products. Total exports of herbal drugs from India are pegged at $100 million. According to the Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council (Chemexcil), India could earn Rs 5000 crore from herbs and herbal formulation exports by 2000.

The market is huge. According to Dr V P Kamboj, director, Central Drug Research Institute, Lucknow, sales of herbal drugs in the United States have touched $4 billion. They are expected to be in the region of $6 billion by 2000. But financial resources are a constraint in establishing a niche in foreign markets, both in terms of establishing credibility and registering and marketing products. Unless you develop proper products and standards, our existing products wont sell abroad, says Parikh. Since herbal drugs do not qualify as medicinal drugs, they are sold as OTC products under the umbrella term dietary supplements.

The largest exporter is the 113-year-old Dabur, though it got into organised exports only around a decade ago. Exports account for a mere 10 per cent of Daburs turnover. But this is expected to go up to 25 per cent in five years. Eighty per cent of its exports comprise value-added toiletries and cosmetics inspired by traditional ayurvedic recipes and based on contemporary cosmetology. According to a Dabur spokesman, single-ingredient herbal drugs like garlic, mint or ashwagandha globules are popular in the European and US markets.

Herbal manufacturers also need to improve packaging to be noticed overseas. For instance, Hamdard exports its general tonic Singhara, drink Roohafza, skin cleanser Safi and digestive Pachmola, all OTC products, mainly to the Middle East and Europe. But we need to tone up our brand and make it trendy to have a presence in the western market, says a Hamdard spokesman.

Hamdard entered the export market only two years ago. Its exports, largely to the Middle East, cater to the immigrant Indian and Pakistani populations here. Apart from OTC sales, it caters to Unani physicians in these countries. Although exports have grown by 300 per cent, they account for five per cent of the turnover.

Over the next five years, the company expects exports to grow by 100 per cent per annum. It should constitute 25 per cent of our annual turnover in five years provided the western markets relax their rules and we manage to satisfy their requirements, says the companys export manager, Shivendra Kumar Srivastava.

Some of the rules have already been relaxed. According to the 1994 US Dietary Supplement Health and Education Act, a company making natural or herbal products can sell it over the counter provided the manufacturers have data to prove the structure or function claim on the basis of clinical trials.

They must also add a disclaimer that the claim has neither been evaluated nor approved by the Food & Drug Association. Since the regulatory body can ask for substantiation of claims, the terminology on the wrappers usually skirts them. So Isabgol cant be said to relieve constipation, which is a medical claim, but can be termed as a bowel regulator. The Act has resulted in supermarket chains and chemists also stocking herbaceuticals .

A number of big western pharmaceutical companies like American Home Products, Pfizer and Rhone Poulenc, have sensed the opportunity and are increasing their presence in the herbal drugs market.

Will this squeeze out the Indian players? A Dabur spokesman believes that the west will not want to reinvent the wheel. Rather, western companies may look for collaborations with the Indian herbal drug manufacturers. S K Sharma, joint managing director of the Rs 100 crore Shree Baidyanath Ayurved Bhawan Ltd, says his company is open to such ventures.

But the single biggest hurdle in the way of establishing herbal drugs as medicines is in clinically testing and establishing their efficacy. This is an expensive proposition. Each drug would involve research to the tune of some Rs 1500 crore, says a scientist at a premier research institute.

Besides, herbal drug companies will also need to standardise processes from cultivation to collection to transportation and storage of herbs.

Some companies like Dabur have begun employing techniques like high pressure liquid chromatography (HPLC) and high pressure thin layer chromatography (HPTLC) to fingerprint and establish the uniform activity of a compound. But this is only the first step. Simultaneous testing of biological activity on animal models is not carried out to test the veracity of a medical claim. Now Dabur Ayurvedic Specialities has identified 300 products in its classical range to establish hygienic standards of production, further research and clinical trials.

Western drug firms reportedly plan to invest $1 billion to initiate research into herbal drugs. They have not yet penetrated the Indian market independently or through collaborations.

Evidently, the growth potential is immense. But the industry will need to evolve standards before it can exploit the opportunities.