The time tested traditional drugs and healthcare system of India, Ayurveda, is still almost a taboo in the developed world albeit its immense credibility in the homeland. The primary roadblocks to this credibility and global success that the Ayurvedic industry currently faces are lack of product standardization and quality control and also absence of documental evidence for clinical efficacy.
Today, it is for sure that every Ayurvedic exporter who wish to take his products to the developed markets, the first set questions faced by him by the respective regulatory agencies is that what is the proof that the product contains all that is claimed on the label and how does the product actually work.
Distributors of herbal supplements in North America and Europe do not want to touch Indian products because of these defects. Most foreign buyers are asking for a minimum of HPLC or HPTLC profiling of the polyherbal product; Active ingredient Assays or Tests for Identification if assays not possible; Accelerated Stability Data; and Phase II Clinical data from a Randomized Controlled Trial in a minimum of 30 subjects per arm.
Following the safety concerns of popular herbs such as St John's Wart and Kava Kava in N. America and history's largest recall of herbal supplements by the Australian TGA (Pan Pharmaceuticals), another question has come up in the consumer's mind: "Is the herbal product I'm swallowing safe??" Most Indian companies in the Ayurvedic Sector reach out to their pockets for R&D spending when there is an actual demand for such data from the overseas customer or potential customer.
This demand could be for product registration/ regulatory purposes or simply to satisfy the customer about product quality and efficacy before he invests his marketing dollars in the Indian product. Often this is a kneejerk reaction and has to be done in a hurry as there is no prior planning or effort. The data needs to be sent to the foreign buyer in a jiffy. The Export department normally makes unreasonable demands of schedule on the Production or R&D teams to "generate" such data. But such experimental data on a proprietary blend of herbs cannot appear overnight. Only companies who can plan such an effort in advance and invest small sums of money and effort year by year will be able to soon develop a respectable package of data of all their products for exports. Gone are the days when herbal products were sold without data.
Charak, Ajanta, Lupin, Dabur and Himalaya are some of the Ayurvedic groups who have invested in product standardization and label claim substantiation work. Lately, the FMCG majors like Hindustan Lever also joined the bandwagon though their involvement in natural product R&D is limited to formulation development in the personal care range.
Some of the other companies have either no will or vision to invest in the future of their products or do not have the internal resources in terms of capital, trained manpower or infrastructure to carry out such an exercise.
Herbal product development to the uninitiated may still be a daunting task. Moreover, putting together a complete marketing-research strategy, research program planning, IPR planning, literature review, lab search, protocol writing, monitoring, analysis and reporting for a complete range of herbal products is something of a 2-5 year plan involving the CEO as well as heads of marketing, exports, medical, purchase, production and research functions.
Here comes the essentiality of professional organizations in the filed of research services to help out the actual manufacturers and exporters of Ayurvedic drugs. The role of such CROs catering to these diverse special needs of small to large-scale manufacturers of Ayurvedic and herbal health-care and beauty-care products are very crucial.
The first such contract research institution in the organised sector in India by the name Vedic Lifesciences, was set up in 2001. Vedic Lifesciences has been conceived as a one-stop-shop for herbal quality control, research and consultancy.
The company is promoted by a group with a decade of business experience in herbal product development and quality control. Though the company made modest beginnings with local clients in areas such as Cancer, Arthritis, Immuno-modulators, Protein Supplementation, etc with projects involved mostly literature review, research planning, invitro and invivo screening for various biological activities, oral toxicity studies, etc, several of these clients have now progressed from pre-clinical to Phase II Clinical. Hence this year Vedic Life sciences has seen a large number of requests coming in for Phase II clinical studies for herbal products from existing as well as new clients. Clients are now spread over USA, Canada, Malaysia, France and the Netherlands.
The Vedic Lifesciences team consists of protocol writers, clinical research associates, data entry personnel, quality control and SOPs group with collective background of the pharmaceutical sciences, Ayurveda, homeopathy, medico-marketing, clinical pharmacology, animal pharmacology and marketing. In order to tap the expanding markets, the company has now joined hands with like-minded organizations in this sector in the country and abroad. Plan to enter into more such alliances in 2004-05.