Burning issue - Present status of Pharmaceutical Industries
“Recent acquisition of Indian generic drug companies by MNCs has increased fears that the price of low-cost generic drugs will rise in India. The buy-outs will reduce domestic availability of many essential medicines; point out an internal assessment of the health ministry, Government of India. It is ironic that despite India supplying quality generic drugs around the world, the country has concerns about sufficient domestic drug supply and vaccines security. With the increasing acquisition of Indian companies by overseas drug corporations, there is a pressing need to rethink India’s drug strategy”. This statement was released by government of India before few months. Now what global honchos think about India?
On a recent visit to India, Andrew Witty, global top boss - GlaxoSmithKline told “Indian has been slow in terms of innovation and needs a robust intellectual framework so that firms who invest have a certain level of certainty that they will be rewarded for risk. This presence of protection is necessary to recoup investment innovation may it be patents, data exclusivity or any other mechanism”. He was addressing organization of pharmaceutical producers of India (OPPI) and said “cost of failures has pushed up drug process to billions of dollars”. After having established itself as a global leader in IT and pharma generics, India is not only poised to emerge as the world's auto factory and medical tourism hub, but also as a global peacemaker as it can offer the world the great Indian dream that strikes the ideal balance between materialism and spiritualism; management guru Philip Kotler has said in a Hyderabad based function recently in India. He further told “you certainly have the brain power; you have schools like IITs and IIMs. India has done a tremendous job with IT and generic drugs.
But what will India be selling five-six years from now”?
Pharmaceutical industries are at cross roads owing to rapidly drying pipeline with fewer potential molecules at various phases of clinical trials, yet to see their names in prescriptions. Research and development and subsequent patent benefits are the main source of the economic value that the pharmaceutical industry creates for its survival in market and to further boost itself to engage in the very aim of research and development. It is therefore not surprising that the evidence of a major decline in R&D productivity has led to a sense of catastrophe. Drug discovery and development is a long voyage requiring whooping fund besides involvement of mélange of people from varied backgrounds, and facilities.
If it does not fructify then there is huge loss in terms of efforts, resources and perhaps most importantly capital. Though there is technological advancement which is being employed in various steps and processes during drug development and discovery like genomics, proteomics, combinatorial chemistry (CC), DNA shuffling, combinatorial biosynthesis, bioinformatics, high-throughput screening (HTS), incorporation of robotic stuff, but pharmaceutical industries are witnessing a tough time due to shrinking R and D pipeline, poor productivity, ever increasing cost of drug discovery programs and cash crunch. High failure rate and less innovative pipeline raise concerns on the robustness of R and D process. There are hosts of new ways industries are trying to get around it. Pharmaceutical companies are on the spree of merging or acquisition or some sort of joint venture in an attempt to make profits while churning out some fruitful products/molecules for society. This approach has worked successfully outside the pharma industry and some companies, given the long lead times to market and the intrinsically scientific nature of the drug discovery process, new models that have worked for technology companies such as IBM and for consumer product manufacturers like P&G may not be entirely appropriate for the pharmaceutical industry.
As far as cost pressures are concerned, the pharma industries are very aggressively rationalizing cost structures across board. Layoffs, reorganization, shutting down of facilities, outsourcing/offshoring, and new commercial models are among the many changes being implemented.The decade-old promise of the Human Genome Project in the form of pharmacogenomics is not yet living up to its full potential, while the diseases of old age represent a new pipeline but the complexity of these illnesses – Alzheimer’s, Parkinson’s, cancer, cardiovascular, even obesity and aging itself – seem to require something more than pharmaceutical intervention. Macromolecular medicine using peptides, proteins, and genetically modified antibodies are struggling to get out of clinical trials and into the clinic.
Moreover there is escalating pressure from regulators. Chinese and Indian drug makers have taken over much of the global trade in medicines and now manufacture more than 80 percent of the active ingredients sold worldwide but these countries also lagging behind when it comes to churning out new molecules. With a large number of drugs nearing patent expiry and fewer blockbuster molecules; major pharma companies will lose about 15 percent of their revenues. It is expected that around $81.5 billion worth of branded products will loose patent privilege. November 30, 2011 has witnessed Lipitor (world’s largest selling pharmaceutical brand) loosing its patent in US and coming out of comfort zone. Atrovastatin containing this blockbuster brand is owned by pharmaceutical giant Pfizer. In 2007, the US Food & Drug Administration (USFDA) approved just 17 new drug products for market, the lowest number since 1983. Looking at this scenario of pharma industries, mostly engaged in discovering drugs from synthetic sources, looking back into nature in a full fledged way will be a silver line. Human history is replete with several uses of natural resources, plants being the cardinal ones. It is the beauty of plants to provide phytoconstituents that serve as nutrients, essential factors, therapeutics and toxins which have given them an invaluable role in human development. Most of the therapeutic agents which are in clinical practices have been derived from natural sources directly (involving only extraction and purification steps) or indirectly (synthetic offspring-after deciphering the structure of the natural molecule or semi-synthesis of altogether a new skeleton from metamorphosis of natural molecule).
Traditional medicines are gaining recognition around the world for their efficacy in the treatment of adult and degenerative diseases. Natural medicines and medical plants hold promise of being the key to the development of new drugs. Perhaps it would have been difficult for human being, had it not been done by morphine, reserpine, aspirin, ephedrine, taxol, quinine, digitalis etc. They are the molecules which helped mankind time to time and chemists to develop more suitable synthetic siblings or offsprings. Researchers in natural medicine have played a significant role in maintaining and strengthening human health and will continue to do so in the future. Ethnopharmacology and natural product drug discovery remains a significant hope in the current target-rich, lead-poor scenario. A quick look into history reveals that for each of the pioneer molecule, for combating almost every class of diseases, nature played incomparable role. Despite this fact, turning back to nature by pharmaceutical industries is beyond comprehension and something uncalled for.
Dr. Amit Gangwal
Smriti college of pharmaceutical education, Indore (MP)