The Hindu Business Line : We need quality standards in plant-based drugs

The modern pharma industry is stuck with a dry pipeline and plant-based medicines are good alternatives. There must be more initiatives and sops from the government to give it a thrust so that these initiatives will bear fruit in the next decade. — DR P. M. MURALI, FOUNDER DIRECTOR, DALMIA CENTRE FOR RESEARCH AND DEVELOPMENT

The Indian system of medicine is ancient. But what's happening now is a virtual rediscovery of how drugs from the ancient systems work and also how to manufacture them, says Dr P. M. Murali, Founder Director and member of the Governing Board of the Dalmia Centre for Research and Development (www.dalmiaresearch.org). He has more than two decades of research experience with plant-based products and quality control. Dr Murali has been the principal investigator for a number of government projects and also for the various clinical trials.

Dalmia Centre for Research and Development or DCRD was earlier DCBT or Dalmia Centre for Biotechnology, promoted in 1990 by Mr Sanjay Dalmia and Mr Anurag Dalmia of the Dalmia Group. DCRD is recognised by the Department for Scientific & Industrial Research, and has an ISO certification for herbal drugs. It has carried out several human clinical trials with plant-based products under strict monitoring conditions for a number of disease indications. Located in Coimbatore, the Centre has a core team of 15 scientific personnel and several collaborators. Here is Dr Murali, answering a few questions from Business Line.

Excerpts from the interview:

Plant-based medicinal research is an ancient science. What is new about it?

Much of the insight for development comes from natural products. Plants have contributed to a number of inspirational molecules including the blockbuster `statin' drugs. Ayurveda, Siddha and other Indian systems of medicine, Homeopathy, and Unani have all a huge compilation of treatment procedures for a number of diseases with plant and metal-based formulations. However, these systems do not offer the same window of understanding of how the drug works, as is the case with present day medicines. Without a knowledge of how these Indian medicines work, modern physicians do not feel comfortable prescribing the same. For large-scale manufacture, quality and consistency of the product is key — a problem, again, that switching from traditional to modern methods would face. It is likely that mass manufacture was not done in ancient times when drugs were prepared by `vaids' for a local population; issues such as stability, storage and methods of manufacture were possibly not encountered then. Hence, while the therapeutic properties of plants are known, the other areas concerning the commercialisation are yet to be standardised. Which explains why there is now a rediscovery of how drugs from Indian systems work and also how to manufacture them.

What have been the projects in your Centre?

Our projects have been on respiratory diseases, mainly asthma and chronic obstructive pulmonary diseases. We have worked on plant-based products for harm reduction, particularly addressing the tobacco menace. Our thrust is on even more important problems such as Hepatitis C, dementia and arthritis. Reason for choosing to work on these diseases is that modern biomedicines do not have `ideal' drugs to address these diseases, and also because plant-based products show greater promise in mitigating suffering with fewer side effects.

Which are the major countries that have achieved progress in this line of research?

The Chinese have an edge over Indian systems of medicine. Chinese medicines are traded in more countries. Chinese medicines have not drawn the adverse attention of regulatory authorities the way our herbo-metallic products have come under scrutiny. Japan and Korea are doing significant work, and publishing their research.

To what extent has research in this sphere moved on to the development phase and translated as commercial products?

Considerable processes have been set into motion in India but these should have happened much earlier. We have only reacted to bans or bad press to our drugs and then set about planning how to solve it. Even though it is better late than never, if we were pro-active to the changing world and requirements, we could have easily had a better situation than what we are in today commercially.

One example is our `slow' approach to set standards for plant-based drugs. Also, manufacturing under Good Manufacturing Processes (GMP) should have begun long ago. Even reputed manufacturers in India have suffered in the hands of overseas drug testing houses as a result of producing non-standard products.

Research is now trying to strengthen the industry by bringing in advanced instrumentation and effective standardisation to combat inconsistencies. Products, packaging and labelling of the products are now slowly gearing up for the international consumer. On the whole, we are now moving.

How affordable are plant-based medicines? How big is the market for these products?

Well, the market is huge. The oft-quoted statistic is that 60 per cent of the US population has at some time used products of natural origin. Trend these days is to consume things that are of natural origin. Also, since the basic active scaffold of the molecules of nature are untampered (that is, not modified by chemists), chances of side effects are generally low. This makes the products very desirable for use. Demand for nutraceuticals and other functional foods will grow at a rapid pace in the years to come. At present plant-based products are affordable. However this is likely to change with a greater emphasis on quality and regulatory aspects. Nutraceutical and lifestyle products are already marketed as premium products. For the poor, the Government and primary health channels may have to subsidise the products.

Do government policies impede the growth of plant-based medicinal research?

Firstly, the Government can spend more in this area. The R&D (research and development) funding should have a very specific thrust on Indian system of medicine, and on diseases that are of considerable relevance, and metabolic diseases such as diabetes, and coronary heart disease. Research institutions that are exclusively into Indian systems should be incentivised and encouraged to carry out further work. Such institutions should not be basketed with pharmaceutical research institutions.

Also, the Government needs to have a number of systems put in place for streamlining this area. A coordinated effort to bring in quality standards in plant based drugs and in implementing the standards rigorously should be top in the list of things to do.

Government must keep a watch on the changes that regulatory authorities around the world bring about to herbal and plant based products, so that we react to these requirements appropriately. Not many Ayurvedic and Siddha drugs can meet the demanding FDA (Food and Drug Administration, US) requirements because most of the drugs from the Indian System are multiple plant cocktail formulations.

If they are to be sold as Ayurvedic drugs abroad then who will prescribe them, as presently one system of medicine is not prescribed by the other? If they are sold as over the counter products, then how serious can they be? It is important for the Government to adopt a comprehensive approach and see how to address these issues. As in the case of information technology, this is an area with promise, and is possibly going untapped. The modern pharma industry is stuck with a dry pipeline and plant based medicines are very good alternatives. There must be more initiatives and sops from the government to give it a thrust so that these initiatives will bear fruit in the next decade.

What are the skills required of a new researcher in your field?

The industry finds it difficult to get new researchers with the desired skill-sets, as the present system of teaching is bookish. We need people who can apply reasoning and be inquisitive. The younger generation still feels that taking up research and settling down in life is a long route. Also, these days, every single science faculty member has to have multi-disciplinary knowledge.

Even for the learned and experienced it is highly intriguing how people in ancient times put together such a beautiful compendium of treatment methods without the modern gadgetry. It only goes to prove the superiority of their education system. Somehow, this has to be rediscovered as well. Maybe, completely different approaches to the understanding of medicine coupled with a bit of patriotism and pride that Indian systems were in existence much before modern medicine, and that many of the formulations still bring relief and mitigate suffering can bring in fresh air to this field.

On the challenges that research faces at the frontier, which may unravel in the years to come.

The biggest challenge will be in trying to put in place processes for multi plant cocktail formulations. Also, since most people are going to have these formulations in conjunction with some other biomedicine, it is important that drug-drug interactions are well studied. There is an onus on Indian scientists to prove how herbo-minerals work and that they are safe for consumption. Publications in peer-reviewed high impact journals should increase. GMP norms for manufacture will soon be the minimum standards and, hence, this area will also see improvement in the future.

More than all these, drugs of Indian origin should be prescribed by physicians from biomedicine. For this to happen, Indian system and modern biomedicine should speak the same `language' that is understandable by both the faculties. Unless more research is done to back the therapeutic claims of Indian systems through structured research, the drugs will still have to be sold over the counter. Future research should pave the way for offering a number of `proven' drugs to the modern world where biomedicines have not delivered. Cross-training of professionals from the Indian system and modern medicine is a must.

MuraliDe@gmail.com

D. Murali

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