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Innovation, IPR and Indian Pharmaceutical Industry – a growth formula is brewing.

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Innovate or perish:Many of us expect that ‘tomorrow’ will be a ‘mega today’ and prefer to run our business more or less the same way, as what we are doing today. At the same time the global market keeps us sending, in very small measures though, but definite and continuous signals of change. As we move on, we realize that ‘tomorrow’ will not be a ‘mega today’, just as ‘today’ is not a ‘mega yesterday’. To meet such challenge of change squarely and realistically, we need to embrace a culture of ‘continuous innovation’.Therefore, the name of the game, while competing within the globalised economy is “continuous innovation”. An innovation, as we know, is more than a novel idea. It is, in fact, the process of translating the novel idea into reality.

Like other industries, the pharmaceutical industry in India will also have to innovate with cutting edge ideas, convert them to innovative and implementable business models, which in turn would help these companies to remain competitive in the market place. The innovation, which I am talking about, extends beyond Intellectual Property Rights (IPR).

While innovation is an absolute must to remain and grow the business, having patented products and marketing these brands effectively are desirable and not a ‘must do’ in the pharmaceutical industry of India.

Many would like to ‘stick to knitting’ and innovate:

Indian Pharmaceutical Industry is now an internationally acclaimed player in process development, contract research, manufacturing and domestic marketing skills. The Government of India created this environment for the industry through amendments of the Indian Patents Act 1970.

During post product patent regime in India, there is no dire need for the entire domestic industry to shift its focus from world class process development skills to new molecule development skill. On the contrary, the strengths acquired by the domestic industry in such skill sets should be further honed, to utilize benefits from opportunities that arise out of basic R&D processes. Some of these are collaborative activities with the multinational companies (MNCs) to create a win-win situation in areas like, contract research, clinical development, contract manufacturing and domestic marketing of in-licensed products.

The domestic pharmaceutical industry should therefore adopt strategies like manufacturing off patent products, like recent collaboration between Aurobindo Pharma and Pfizer, Jubilant Organosys with French company Guerbet, for distribution of its nuclear medicine products in Europe. ‘Financial Express’ dated March 13, 2009 reported “Eli Lily seeks partner for Indian TB initiatives.

Such opportunities will keep on coming, may be more frequently and more in number, especially when global innovator companies take more interest in the generic pharmaceutical business, like, Novartis, Daiichi Sankyo, GlaxoSmithKline, Sanofi Aventis etc.

To grab such opportunities, the strategy of ‘stick to the knitting’ with continuous innovation is expected to help the domestic pharmaceutical companies immensely.

IPR regime – emerging opportunities:

Discovery Research:

While above approach will help many small and medium sector enterprises, many large pharmaceutical companies and research boutiques in India are investing significantly to discover New Molecular Entities (NMEs). It has been reported that by 2011, at least two Indian pharmaceutical companies are planning to launch their NMEs.

Biotech Research:

Research in the field of Biotechnology is rapidly evolving, especially in the areas of diagnostics, vaccines, cellular and molecular biology. It is heartening to note that for doing stem cell research National Institute of Health, USA, identified Reliance Life Sciences in Mumbai and the National Institute of Biological sciences in Bangalore to receive state funding from the USA. Both these two organizations entered into contracts to supply embryonic stem cells to the US based researchers. Moreover, in the field of ‘Biometrics’ raw clinical data are now being transmitted to the specialists in India for their scientific evaluation.

It has been reported that in the developing countries of the world malaria afflicts about 300-500 million population and kills 1-3 million of them. Malaria also allows some fatal genetic illnesses, like sickle cell anaemia to thrive in the gene pool. Hence a vaccine developed for this disease through Indian biotech initiatives, would indeed be a great boon for the developing countries of the world.

Industry – Academia Collaboration:

In the Western countries, close collaboration exists between the industry and academic institutes in the field of Pharmaceutical Research. Such type of collaboration has now started developing in India too, where Council of Scientific and Industrial Research (CSIR) is playing major role.

An effective collaboration between the pharmaceutical industry and the academia will ensure productive use of research talents where both the parties will draw benefits. The research done by the CSIR, Indian Institute of Technology (IITs), Indian Institute of Science and various universities is expected to throw open new avenues of collaboration and partnership between industry and Academia.

Benefits of Technology Transfer and increased Foreign Direct Investment (FDI):

The new product patent regime is also expected to facilitate flow of technology and foreign direct investment in India with adequate patent enforcement mechanism being put in place. Inadequate patent and regulatory data protection are considered by the developed nations as the key barriers, which restrict the flow of both technology and foreign investments.

In these areas, India mainly competes with China and Brazil, besides other emerging markets. Degree of patent and regulatory data protection in each of these countries will eventually decide who will emerge as a winner in these fields.

The issue of ‘Access to New Innovative Patented Drugs’:

Innovative pharmaceutical products patented in India will facilitate access to the latest modern medicines to Indian population. Such medicines will help to meet the unmet needs of the ailing population. Many multinational companies like, Merck, GlaxoSmithKline (GSK) have already announced a differential pricing mechanism for such medicines in the developing countries.

Moreover, to improve access of such medicines to the common man, the Government of India should have robust plan to purchase these medicines, at a negotiated price, for supply to Government Healthcare Units

Improving ‘Access to affordable modern medicines’ – a challenge to the nation

There are three key elements to improve access to affordable medicines to a vast majority (650 million) of Indian population:

1. Healthcare infrastructure and delivery
2. Healthcare financing
3. Procurement price of these medicines at the Government Healthcare units

Price of patented products will not have any impact on existing medicines available in the market. However, the reality is, price regulation in some form will continue to play a key role in India. The long overdue new Drug Policy of India is now expected to come only after the new Government takes charge, post General Election of the country. The new policy is expected to articulate the details on this important subject both for patented and generic medicines, in India.

A determined and focused approach of the Government on the above three elements would effectively address the key healthcare issues of India.

Small Scale Enterprises in India – expecting large scale consolidation:

In India over 70% of the small-scale units, within the pharmaceutical industry, currently operate as contract manufacturers, either for the domestic or multinational companies. These small scale units with their low operating cost ,make the contract sourcing model an attractive proposition. Many of these small scale enterprises, are mostly catering to the export business in non-regulated markets.

The demand for high quality standard by the drug regulatory authorities of various countries is fast increasing. It is, therefore, essential for these units to make significant investments to qualify for such stringent quality requirements. Some units would be able to invest enough to meet such regulatory standards. However, the cost of production for those units, which will invest towards facility up gradation is expected to increase significantly, leading to fierce cut throat competition. In a situation like this, we can expect to witness a large scale consolidation process within the industry.

Intense competition from China – cannot be ignored:

Globalisation of the markets could lead to significant dumping of products in different countries. Such a situation may adversely affect the cash flow of business, making the domestic industry highly vulnerable. Currently, Indian manufacturers are facing intense competition from China, in Pharmaceutical Intermediates (PI) and Active Pharmaceutical Ingredient (API) segments. This is mainly because China has a much better economies of scale in manufacturing, which gives them a pricing edge over their Indian counterparts.

PI and he API manufacturers in the small scale enterprise segments of India have already been very adversely impacted, leading to closure of many units in various states like, Andhra Pradesh, Karnataka and Gujarat.

Conclusion:

The issue of a robust world class patent regime in India has sparked off an intense debate with a heavy dose of acrimony. The key areas of concern of various stakeholders are as follows:

1. General public: inadequate access of affordable modern medicine to the common man
2. Domestic generic industry: overall industry growth and to some extent its survival
3. The Government of India: combination of 1&2

After many years of tough resistance mainly from the domestic generic pharmaceutical industry, in January 1, 2005, India re-entered into the pharmaceutical product patent regime. In this article, I have tried to give a snapshot of this new regime, for a quick reading.

Despite tough competition from China and increased possibility of consolidation within small scale pharmaceutical units, overall emerging scenario in India is indeed encouraging. Imbibing innovation culture and with the opportunities available in the new IPR regime, Indian pharmaceutical industry, I believe, will be able to catapult itself to newer heights of global success.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Biosimilar Drugs -A raging scientific debate with mounting global commercial interest

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On December 11, 2008, Reuters reported that two days after Merck & Co. announced a major push into generic versions of biotechnology medicines, Eli Lilly & Co. signaled similar aspirations. This report raised many eyebrows in the global pharmaceutical industry, in the midst of a raging scientific debate on this issue. Be that as it may, many felt that this announcement ushered in the beginning of a new era. An era of intense future competition with Biosimilar drugs in the world market with immense commercial interest.Globally, the scenario for generic versions of biotechnology medicines, which are called Biosimilars, Biogenerics or follow-on Biologics, started heating up when Merck announced that the company expects to have atleast 5 follow-on biologics in the late stage development by 2012. The announcement of both Merck and Eli Lilly surprised many, as the largest pharmaceutical market of the world – the U.S.A is yet to approve the regulatory pathway for generic biologic medicines. In the developed world, European Union (EU) has taken a lead towards this direction by already having a system in place for regulatory approval of Biosimilar drugs in 2003.What then prompts the research based global pharmaceutical companies like Merck and Eli Lilly to step into the arena of Biosimilar medicines? Is it gradual drying up research pipeline together with skyrocketing cost of global R&D initiatives?

The future business potential of Biosimilar medicines:

Currently, over 150 different biologic medicines are available in the Global Pharmaceutical market. However, the low cost Biosimilar drugs are available in just around 11 countries of the world, India being one of them. Supporters of Biosimilar medicines are indeed swelling as time passes by. At present, the key global players are Sandoz (Novartis), Teva, BioPartners, BioGenerix (Ratiopharm) and Bioceuticals (Stada). This market is expected to develop slowly because of regulatory hurdles in the major countries of the world.

Very recently, the EU has approved Sandoz’s (Novartis) Filgrastim (Neupogen brand of Amgen), which is prescribed for the treatment of Neutropenia. With Filgrastim, Sandoz will now have 3 Biosimilar products in its portfolio.

Raging debate on Biosimilar Drugs still continues:

The debate is centered on the argument that like small chemical molecules is it possible to replicate large biological molecule of the innovator? It is widely believed that a protein cannot be absolutely replicated. How could possibly then Biosimilar drugs be considered equivalent to the original product by a regulator and marketing approval be granted to them without full scale clinical trials ignoring safety concerns of the patients? In favor of this argument some refer to the problem of red cell aplasia that affected many patients administering Johnson & Johnson’s Exprex (Epoetin) after only a minor change made in its manufacturing procedure.

Hurdles to cross for future Market entry of Biosimilar Drugs:

Emergence of second generation branded biosimilar products such as PEGylated products Pegasys and PegIntron (peginterferon alpha) and Neulasta (pegfilgrastim), and insulin analogs etc. have the potential to reduce the market size for first generation Biosimilar drugs creating significant entry barrier.

Even otherwise, the barriers to market entry of Biosimilar drugs are much higher than any small molecule generic drug. In the markets within EU, many companies face the challenge of higher development costs for biosimilar drugs because of stringent regulatory requirements and greater lead time for product development. Navigating through such a tough regulatory environment will demand a different type of skill sets from the generic companies not only in areas of clinical trials and pharmacovigilance, but also in areas of manufacturing and marketing. Consequently, the investment needed to take Biosimilar drugs from clinical trials to launch in the developed markets, will indeed be quite significant.

Current Scenario in the U.S:

Recently in the U.S.A, the new, widely reported, biotechnology policy of President Barak Obama has become one of the most closely watched healthcare policy initiatives of the country. It is expected that such a policy will help facilitate regulatory approval process of Biosimilar drugs in the USA by end 2009. This new policy initiative could have a major impact on many biotech companies who will face new generic competition, rather quickly. On the other hand, it will prove to be a boon to the new entrants in this market like, Merck and Eli Lilly, besides the existing ones.

Global Market Potential of Biosimilar Drugs:

The biosimilar drug market in the world is estimated to be around U.S. $ 16 billion by 2011. Currently, off-patent biologic blockbusters including Erythropoietin offer an excellent commercial opportunity in this category of drugs. By 2013, about 10 branded biologics with a total turnover of around U.S. $ 15 billion will go off-patent.

Biosimilar Drugs in India:

Sales of biosimilar drugs in India are estimated to be around U.S. $ 4 billion by 2011.

Biosimilar drugs fall under high growth segment within Indian pharmaceutical Industry. Recombinant vaccines, erythropoietin, recombinant insulin, monoclonal antibody, interferon alpha, granulocyte cell stimulating factor like products are manufactured by a number of domestic biotech companies like Biocon, Panacea Biotech, Wockhardt, Emcure, Shantha Biotech, Bharat Biotech, Serum Institute of India, Dr. Reddy’s, Ranbaxy, etc. The ultimate objective of all these Indian companies, I am sure, will be to get regulatory approval of such products in the EU and then in the U.S. when the time comes.

It is worth mentioning here that to give a fillip to the Biotech Industry in India, the National Biotechnology Board was set up by the Government of India under the Ministry of Science and Technology in 1982 and the Department of Biotechnology (DBT) came into existence in 1986. The DBT now spends around US$ 200 million annually to develop biotech resources in the country and have been making reasonably good progress. The DBT is reported to have undertaken an initiative to prepare regulatory guidelines for Biosimilar Drugs, which is expected to conform to international quality and patients’ safety requirements.

The points to ponder with the Biosimilar Drugs in India:

It is, indeed, quite surprising that in India there is still no separate transparent and published guidelines for regulatory approval of Biosimilar drugs, although the Drug Controller General of India (DCGI) seems to have a different view in this matter. The Drugs and Cosmetics Acts of India have no separate provisions either, for Biosimilar Drugs. In a situation like this, we find that many Biosimilar Drugs are still getting regulatory approval in India.

Currently India supplies 30% by volume of the global requirements of generic drugs both in regulated and non-regulated markets. In the regulated markets like North America and EU, for small molecule generic products, Indian manufacturers conform to the global safety and efficacy standards by getting these products approved by the most stringent regulators of the world like, U.S. FDA, MHRA (Medicines and Healthcare products Regulatory Agency) etc. The very fact that none of the Biosimilar drugs developed in India could get approval in the EU as yet, may well suggest that the stringent regulatory requirements for both efficacy and patients’ safety followed in the EU for Biosimilar drugs, could not be met by the Indian manufacturers, as yet. The question, therefore, comes to my mind whether the Biosimilar drugs manufactured in India conform to international quality and safety standards? If not, who will address the safety concerns of the patients who are or will be administering these medicines?

Such a concern gets vindicated by widely reported serious quality problems, detected by the drug regulatory authorities, at some large and well known Biosimilar drugs manufacturing units in India and also from the condition of some vaccine manufacturing units in our country.

India needs to manufacture the world class Biosimilar drugs conforming to the highest efficacy and patients’ safety standards, just the way Indian pharmaceutical manufacturers have demonstrated with ‘made in India’ generic drugs, the world over. The Indian drug regulatory authority should now take some important initiative with the publication of world class Biosimilar drugs regulatory approval guidelines, may be following the similar process as what we see in the EU.

Currently, experts from India are participating towards preparation of ‘WHO Guidelines’ for Biosimilar Drugs. The progress made towards this direction is yet to be ascertained. Simultaneously, the DBT is reported to have under taken an independent initiative to prepare similar guidelines, the progress of which is also yet to be known.

Before other developed markets open up for Biosimilar drugs, if India can align itself with its own world class regulatory standards for the same, yet another significant export opportunity could be created for the country, competing with the best performers of the world in this category.

Meanwhile, it will only be good to know that like many other initiatives, India has taken one more important initiative to address this important issue, for the sake of humanity. As the existing process of granting regulatory approval for Biosimilar drugs continues in India, the lurking fear towards patients’ safety with such drugs will remain unabated with a large majority of experts in this field.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

We need to encourage the new product patent regime

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Ushering in the Product Patent Regime in India heralds the dawn of a new era. The era that vindicates not only the need to encourage, protect and reward innovation for the rapid progress of our nation but also to compete effectively, in the knowledge economy with the best in the world to establish India as a leading country with a significant share of the global economy.However, it is quite unfortunate that the patents that protect today’s innovations and drive research and development to create tomorrow’s life-saving treatments are under criticism from some quarters.India chose to follow an alternative to Product Patent regime for many years. In 1970, the Government of India amended its IP laws with a clear objective in mind to reduce the prices of medicines to improve their access to the ailing population of the country.

As a result, some drugs were made cheaper. However, the moot question that we need to address now: was it a panacea? While looking back, it does not really appear so. On the contrary, the situation remained as gloomy thereafter, so far as the access of medicines is concerned. After almost 4 decades of continuation with the above policy, around 65% of Indian population still do not have access to cheaper off-patent medicines against comparative figures of 47% in Africa and 15% in China (Source: International Policy Network, November 2004).

Children still go without routine vaccinations, though the Government has made the primary vaccination programs free in our country, for all. Even in a situation like this, where affordability is no issue, only about 44% of infants (12 – 23 months) are fully vaccinated against six major childhood diseases – tuberculosis, diphtheria, pertussis, tetanus, polio and measles.

Moreover, as we know, despite distribution of cheaper generic HIV-AIDS drugs by the Government and others mostly free for years, only 5% of India’s AIDS patients were receiving any drugs by the end of 2006.

The above two important examples prove the point very clearly that, addressing the issue of price alone will not help our country to solve the issue of poor access of medicine to the ailing population of India. Only a sharp focus on rejuvenation of our fragile healthcare system, healthcare financing and rapid development of healthcare infrastructure of the country by the Government or through Public Private Partnership (PPP), will help address this pressing issue.

Indian Patent Act 2005 has paved the way for innovation and hi-tech research and development within the country. Contrary to adverse forecasts from some quarters, prices of medicines have not gone up.

However, while medicines play a relatively small role in rising overall health care spending including hospitalization, it is important to ensure that individuals with large healthcare expenses have affordable access to their medicines. Thus a good affordable insurance coverage (both Government and Private) available to all Indians belonging to various socio-economic strata, together with the above measures, will help address the key issues of both access and affordability of medicines for all, in a holistic way.

The attack on patents is not really a defense of patients or the poor. Such attacks help diverting attention from the core healthcare issues, as mentioned above, which are healthcare system, healthcare financing and healthcare infrastructure. Health of our nation will depend on how well these key issues are being addressed by the policy and decision makers. Our country cannot afford to ignore that Intellectual Property is one of the keys to prosperity of a great nation like India and it should be encouraged, protected and rewarded under a robust Patent Act of the country for inclusive growth.

By Tapan Ray

Disclaimer:Views/opinion expressed in this article are entirely my personal, written on my individual and personal capacity. I do not represent any other person or any organization for this opinion.