Running the export marathon
India’s growth in ayurvedic exports has remained flat over the years, unlike exports of pharma generics and contract services, which are seeing phenomenal growth rates. In the race to put up branded goods on the consumer shelf, ayurveda remains far behind Chinese, Korean and South American traditional medicines. Our natural products exports are a mixed bag of finished goods, but also include therapeutic and food ingredients (flavouring), large number of excipients (gums) and essential oils for foods, perfumery, etc. In fact, yoga has scored far better than ayurveda as a ‘product of India’ on the international scene. Ayurveda or herbal products of Indian origin have not made a significant mark either in nutraceuticals or in pharmaceuticals in the global healthcare markets. There is no third side to this coin. Our current herbal offerings (APIs or formulations) lack either the strong branding needed for the nutra markets or the foolproof science for the pharma approvals, or both. So we are nowhere. Proof is in the statistics. To be fair to the greens, even the pharma team has not yet won the innings in the ‘innovation series’, though there have been commendable openings by the likes of Glenmark and Dr Reddy’s.(source: DGFT Website)
Speak the right language
The West does not understand ayurveda or ayurved but we keep harping on ayurvedic medicines and herbal products. These classes of goods do not exist in the West. When an American consumer gets into a health food store like GNC or a pharmacy store like Walgreen, she wants to buy a dietary supplement for her aching knee joints. She has heard of glucosamine sulphate and picks a bottle. She doesn’t care if it is ayurvedic, plant-based or animal origin. The pharmacy chain stocks it because it can sell it legally in the US as a dietary supplement. On the other hand, ayurvedic medicine as a cure is not understood and not acceptable. Indian marketers would be better off first getting a presence in the existing segments of dietary supplements, functional foods and herbal personal care products and then build a new segment like ayurveda. Ayurvedic medicines as a regulatory class are recognised in some countries now, but their collective brand equity is questionable. Present day leading ayurvedic houses must either shed their traditional ideologies or be content with a domestic market. Recently, a new class of regulated products has emerged in the US and EU under the terms botanical drug products (BDPs) and herbal medicinal products (HMPs) respectively. This is an opportunity for the proponents of ayurveda who constantly claim that ‘ayurvedic products are medicines and not food supplements’. However, they must take up the challenge and ensure that their ayurvedic medicines measure up to the standards set by the Western boys to protect their own pharma turf. I believe that ayurveda is a superior science; however, if we go knocking on someone’s doors for business we have to play the music he likes to hear and not the trumpet of our ‘5000 year old tradition’. The choice of the language will be based on the brand we decide to build for Indian exports.
Clearly any national effort has to be collective. The Government via its policy makers, regulators and export promotion councils is clearly responsible, but the various trade bodies (Indian Drug Manufacturers’ Association (IDMA), Ayurvedic Drug Manufactures Association (ADMA), Association of Manufactures of Ayurvedic Medicines (AMAM), The Health Foods and Dietary Supplements Association (HADSA), etc.) need to talk to each other more openly. There are non-governmental agencies like GTZ, Germany, that are actively supporting herbal exports from India. Policy-makers and the industry must have a clear understanding of the markets. We must engage the best market research firms to survey all the major markets for health foods, supplements and herbal drugs and advise on the best positioning for Indian companies as each market is different. Top marketing gurus from pharma, foods, Fast Moving Consumer Goods (FMCG), ad agencies and academia can also be roped in. Primary research is available from international consulting firms, publishing houses, as well as industry specialists. The market survey will lay down the roadmap for the Government and the industry and channelise the investments effectively.
Whichever route is chosen, brand-building still is an effort. The biggest brands in this industry have been built on science but grown by smart marketing. Big brands have been backed with data supporting their marketing claims and differentiating also the technology from competition. This data may be sometimes sketchy and sometimes strong. But India clearly has the advantage in low cost research facilities -preclinical and clinical. Brand-building and growing will require a sustained effort and investment in the best practices for R&D, manufacture, packaging, quality control and export logistics of Indian nutraceutical products.
There is a market opportunity. With appropriate market research done we will even have a road map. We already have the ayurvedic research engine to drive product innovation. What the existing players need is capital. Given the sensible policies, money will flow in. Research grants and soft loans (free/cheap money) are always welcome, but we need to infuse capital from investors (smart money) who will help in building a solid business. Investments could be from existing players in Indian pharma, foods, FMCG, and other sectors. Smart money like Foreign direct investment (FDI), Venture capital (VCs) and Private Equity (PE) firms should be welcomed.
International best practices
India’s indigenous medicine manufacturers have to cater to the price-sensitive domestic healthcare needs, whereas for global compliance, we need to follow international guidelines. With no compromises, we can formulate separate set of regulations to accommodate realities of the overseas and domestic markets. This way exports can develop without blocking access of the Indian consumer to affordable traditional medicine. Industry must reciprocate and implement international best practices in design and development, manufacturing, packaging, quality control and marketing of export-worthy produce.
Industry’s attitude to quality
The industry should stop giving excuses that natural product quality is difficult to control and there will be variability in polyherbal product specifications from batch-to-batch and over the claimed shelf life. US FDA in its botanical drug products guidelines and the European medicines agency in its herbal medicinal products guidelines, give practical and not so expensive suggestions on controlling finished product quality. We should stop complaining about lack of HPLC marker compounds and expensive methods as a lot can be done with some innovative thinking and more importantly, the right mindset. The US Pharmacopoeia and NSF International Dietary Supplements Verification programs in India are also going in the right direction. The spotlight on heavy metals for last two years has diluted our focus on actives. Let us raise a toast to our strong ayurvedic actives and kill the negative hype.
Encouraging R&D spend
With a wonderful drug discovery platform like ayurveda at our disposal, it’s a pity that we don’t have any blockbusters like Ginseng from India. The Government, along with the industry must invest in high class pre-clinical and clinical pharmacology, safety pharmacology, and of course in intellectual property protection to ensure return on R&D investments. These technologies then may be commercialised on Indian players or licensed to strong overseas partners ensuring commercial success and not just academic laurels. The Government must also recognise and encourage Contract Research Organisations (CROs) that can better penetrate and serve the industry than any public lab or hospital. Extension of 150 percent IT sop to even non-DST approved in-house and stand alone research units will help.
Strengthening export regulations
Periodically, we hear some noise about regulating newly launched patent and proprietary ayurvedic medicines. One year, the local FDAs announce that they will need analytical methods before they approve a new patent and proprietary (P&P) medicine for manufacturing and sale. Another year they announce that they will need clinical trial data. I think this and an entry barrier to new-comers while old products continue to flourish even if they are sub-standard is not practical. The policy drawn must instead lay down easier and practical norms to be fulfilled and then enforced fiercely without fear of lobbies. Don’t ask for data which can be easily faked and only lead to corruption (eg. clinical trial data). Quality standardisation is more important than clinical evidence of efficacy and is definitely tougher to fake by unscrupulous applicants. Data submission for re-approval by FDAs should be made mandatory based on the domestic sales of the P&P medicine and for all export items regardless of size of business. I whole-heartedly welcome strong inspection norms for export shipments by Export Inspection Agency (EIA). I think that the EIA will become a partner rather than an obstacle for ASU exporters under the able leadership of current Director Shashi Sareen. Some of these policies may hit our exports for one year but we will emerge much stronger in the long run. Pharmaceutical Export Promotion Council (Pharmexcil) should stop sponsoring our industry colleagues for their foreign jaunts and divert these funds for sponsoring genuine quality improvement projects. Pharmexcil should support exporters for EIA inspection costs. That will be a true market development assistance. Let us develop world class quality then the customers will come running to India instead of us going abroad with a begging bowl.
Developing specialised talent
Neither of the graduates-ayurvedic (BAMS), pharmacy (BPharm) or lifescience-today understand clearly the business requirements of the global herbal industry. Even the multitude of pharmaceutical management programmes that have sprung up in the country has zero focus on the natural products market. I urge entrepreneurs in the training industry and the appropriate government bodies to consider instituting a one year program on the technology and business management of borderline healthcare products in order to meet the growing demand of talent who understand the international business of the phytomedicines and dietary supplements. Some universities and institutes have made small beginnings, but need to get better industry participation.
It’s a marathon
Let us admit that the Indian herbals image is a little better than battered in some of the major markets. Brand-rebuilding is a marathon not a sprint. Let us run to win. Indian natural product industry has to mature as a global player or be content with domestic business. If a traditional ayurvedic medicine (Liv 52) can top the charts of pharma brands in India, we surely have the potential to write a success story internationally as well.
(The author is MD and CEO of Vedic Lifesciences, a Mumbai-based CRO. He can be reached on firstname.lastname@example.org)