Dr. Amit Gangwal
Pharmacy college as a Lecture,
Smriti college of pharmaceutical education, Indore
The pharmaceutical industries world over, are in a period of crisis due to the poor number of approved drug molecules relative to the high levels of R&D investment. The drug industry is facing major scientific and strategic challenges. Conversion of genomics knowledge into new molecules seems to be unimpressive and futile. Moreover competition from generic giants is giving tough competitions to established products. Indian companies are no exception; rather, hardly any molecule has been delivered by Indian companies since time immemorial (readers are kindly requested to correct/update me, if I am not acknowledging some discovered molecule).
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; a renowned management guru, Philip Kotler has said in a Hyderabad based function, few months back. 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”1. But what about innovation at Indian pharma firms?
But a lot said and done, what lies ahead? Where we are going and literally are we marching ahead or limping ahead? A question, need to be addressed? The think tank should brainstorm. Rapidly changing business models and government policies/laws are making unprecedented moves in pharmaceutical industries in world’s largest democracy.Patent application/granted patents are being challenged/revoked in the court of law citing various unexplored grounds in country; making case studies for future. Much talked about pricing system is yet to be finalized by government. Another law is being framed for foreign players who want to invest in Indian pharmaceutical market. If a recent comment by government is to be believed then the firm, who acquires an Indian counterpart, will have to manufacture the drugs till the proposal is under consideration as stated by government “whosoever acquires an Indian firm (producing essential drugs) will have to continue to manufacture those essential drugs till Competition Commission of India (CCI) is empowered to take a view on such mergers and acquisitions." The move is aimed at giving rights to CCI to ask companies to produce a specific quantity of essential medicines after acquiring an Indian entity. Every proposal for foreign investment in existing Indian pharmaceutical companies will be on FIPB (Foreign Investment Promotion Board) table till the time the Competition Act is amended2.
Patent is among those rare and crucial incentives that drive the research groups around the world. Owing to strict grounds being furnished by defending companies in court, the verdict of court in Hyderabad based Natco Pharma’s favour will cause a rippling effect, making a beginning for such provisions.Another major decision announced by court is for global pharma major Pfizer.In a landmark ruling, the Supreme Court has sent back a case involving crucial renal cancer drug, sunitinib (Sutent® of Pfizer) to the patent authorityto ponder over this case, while the domestic company, Cipla is expected to argue against granting of the patent to Pfizer, all over again. At the same time, the court has ruled in favour of Cipla, by lifting an injunction against it, which may pave the way for the launch of a generic version of the drug. Pfizer was granted a patent for kidney cancer drug Sutent in India in 2007. Significantly, Cipla filed a post-grant application and won the case in September this year, with the Patent Office rejecting the claims made by Pfizer over the drug, on grounds that Sutent®did not involve an inventive step. To confront this decree of court, Pfizer appealed in the Delhi high court which granted an injunction restricting Cipla from launching the drug. Last month, Cipla filed an appeal in the Supreme Court against the high court order. The SC order on the case is still awaited3.
Other biggest ever change being witnessed in pharmaceutical world is pushing once upon a time non-OTC (over the counter) products in OTC category (or this seems imminent) and investing heavily into (and launching a vast range of) nutritive products to capture FMCG market in a well strategized manner. The OTC segment has been identified as one of the potential growth drivers for the Indian pharma industry, as the sale of OTC drugs in India has been increasing over the years. The OTC market was worth about US$1.8 billion in 2009 estimates that by 2020, it will grow to US$11 billion4.
Another corporate revamp at higher level is effecting at Abbott Laboratories. Extending its policy of single-CEO/country head, the $39-billion pharma giant Abbott Laboratories is consolidating India operations under a new single leadership, as part of a plan to tap broad operational synergies between the three domestic units. The New York-listed Abbott, which tops India's drug retail market after acquiring Ajay Piramal's domestic formulations business, will soon appoint a new honcho who will manage its $1 billion operations spread across three companies-Abbott India, Abbott Healthcare and Abbott True Care. Pharmaceutical companies have managed their business in much the same way for decades. Indian pharma companies so far concentrated on marketing generic versions of drugs and nothing significant came out from R & D efforts. Discovering and developing a new medicine has always been a highly complex and complicated endeavor, often requiring clever, breakthrough solutions. Indian pharma companies need to spend heavily in R & D under the aegis of a putative R & D/Innovation honcho of a global pharma major, no matter where in the world he/she expertise resides. It is disappointing that the pharma industry spent as much as Rs15000 crore on R&D during the past five years without producing a single new molecule. In sharp contrast, the US drug industry spends $55 billion on more than 450 drugs every year to come out with 26 new molecules. Nothing hopeful has come from Indian giants, especially generic giants. A major part of R&D expenditure has gone to reverse engineering, generics, contract research, clinical research and little to new molecule research. In the US, 80% of R&D expenditure goes to molecule research. That is why the US has high productivity in the entire chain of the molecule development cycle6.
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Besides making efforts to launch generic versions of permitted branded molecules or those molecules going off patent, interest must also be shown to launch new molecules by companies. After all if motto is to make huge money in this Nobel profession then what could be a better way than devising an entirely new molecule for existing disease, rare disease or to address the side effects shown by existent molecule? But I thinks less efforts are required in devising, formulating, launching a FMCG (perhaps healthy biscuits, recommended for diabetics and other similar products claimed to be fortified from view point of nutrition are giving tough competition to pharmaceutical companies having interest in similar products). By very nature of drug discovery process, it seems industries are realizing the potential of nutraceutical markets in various territories and therefore the rate of coming of these products (nutraceutical and allied stuff) in market is much faster than what it used to be earlier. It implies that once a upon time purely prescription/OTC making pharma majors are also hugging this untapped market worth millions of dollar which is in no way less than what can be fetched by devising a new drug molecule, because a drug molecule has far less user than the nutraceutical or medically fortified biscuits, grain products etc. The day is not very far when more elaborated and strict guidelines will be formed to differentiate between OTC and prescription products because in few therapeutic segments this line of difference is seemingly blurring very fast. One major change world has yet to see is anti-obesity formulations which will drive the system to sell anti obesity medicaments without prescription either as OTC product or drug blended nutraceutical or medicated nutraceutical (yes anything is possible in this rapidly changing world of Facebook; moreover this may be possible owing to this man made calamity; obesity). If public (patient) is made aware and updated voraciously and rigorously then rules for few category of drugs (looking at the threat or rate of disorder) may be waived in future. The best quotable example is anti-obesity agents. Paradoxically, two molecules to treat obesity have been withdrawn from market looking at severe side effects.
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. Despite whopping investment in pharmaceutical R&D, the number of new drugs approved by the USFDA remains unimpressive. To help understand this situation, an exhaustive review investigating the record of pharmaceutical innovation has been published after analyzing data on the companies that introduced the ~1,200 new drugs that have been approved by the FDA since 1950. This analysis shows that the new-drug output from pharmaceutical companies in this period has essentially been constant. Original contributor of this Nature article concluded that, contrary to common perception, the new-drug output is not depressed, but may simply reflect the limitations of the current R&D model7. Another beautiful article highlights the growth of research capabilities in emerging economies such as India and China compared to US economy. Original review discusses the outsourcing of some of the more routine activities involved in pharmaceutical R&D such as compound synthesis and preclinical toxicity tests, to organizations in these countries8. Butone thing is beyond comprehension that despite of these goodies why Indian pharma giants are not churning out molecules? Why these off-shore pharma biggies not opening their full fledged R & D centre in India? It is a thought provoking and introspection warranting question. Advances in the understanding of the molecular basis of diseases have expanded the number of plausible therapeutic targets for the development of innovative agents in recent decades. However, although investment in pharmaceutical R&D has increased substantially in this time, the lack of a corresponding increase in the output in terms of new drugs being approved indicates that therapeutic innovation has become more challenging. A large database (that contains information on R&D projects for more than 28,000 compounds investigated since 1990) was examined to understand the decline of R&D productivity in pharmaceuticals in the past two decades and its determinants by Fabio Pammolli et al. The decline is found to be associated with an increasing concentration of R&D investments in areas in which the risk of failure is high, which correspond to unmet therapeutic needs and unexploited biological mechanisms. That report also investigated the potential variations in productivity with regard to the regional location of companies and find that although companies based in the United States and Europe differ in the composition of their R&D portfolios, there is no evidence of any productivity gap9. It is rightly said by Mr. Eli Lilly, grandson of the company founder, Colonel Eli Lilly, “Research is the Heart of the business, the Soul of the enterprise.” Drug discovery and development is a long voyage requiring whooping fund besides involvement of mélange of people from varied backgrounds, and facilities. The most important factor to boost industry productivity and bring innovative new medicines to patients is a through understanding of physiology, pathophysiology and target selection. A keen observer of nature and natural phenomenon (happening in our ecosystem) may lend a good hint towards a break through.
When I posted a question “Which drug molecule deciphered/invented purely by Indian pharma company in India since time immemorial till 13/12/12” on my Facebook wall (Amit Ratn Gangwal Jain), hardly I got any solid comment. It was rather shocking when people liked this question rather to put relevant words. Only one comment came: “Perhaps pimpricin”.
(Author is MPharm., PhD, and a voracious writer and a regular blogger on social website on pharmaceutical affairs and developments, besides being a motivational speaker and personality development trainor. It is his passion to keep close eye on corporate affairs. He is a quizzer and is a victim of marketing and branding bug too.)
1. Amit Gangwal, Burning issue - Present status of Pharmaceutical Industries, Pharmatutor (www.pharmatutor.org/articles)
2. Foreign Investment Promotion Board to vet pharma M&As involving FDI, TNN, Dec 4, 2012 (timesofindia.indiatimes.com/business/india-business)
3. Supreme Court sends Pfizer-Cipla case back to Patent Office, TNN, Nov 29, 2012 (timesofindia.indiatimes.com/business/india-business)
4. Ritul Bapna, Indian pharma : Raising barometer of success beyond generics, Pharmatutor (www.pharmatutor.org/articles)
5. (Abbott set to consolidate India ops)
6. Dhruv Rathi The Indian pharmaceutical saga: Strong on generics, weak in R&D, (moneylife.in/article)
7. Bernard Munos, Lessons from 60 years of pharmaceutical innovation, Nature Reviews Drug Discovery 8, 959-968 (December 2009)
8. Yali Friedman, Location of pharmaceutical innovation: 2000–2009, Nature Reviews Drug Discovery 9, 835-836 (November 2010)
9. Fabio Pammolli, Laura Magazzini & Massimo Riccaboni, The productivity crisis in pharmaceutical R&D, Nature Reviews Drug Discovery 10, 428-438 (June 2011)
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