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      India's strength on basic research has a long way to go

      Posted AtThe Financial Express

      The Indian pharmaceutical industry is one of the fast growing sectors of the Indian economy and it has made rapid strides over the years. The key drivers of the growth and the perception of growth are the potential of the exports of generics to regulated markets, possibilities on the research and development front and the domestic market.Various events around these drivers make the Indian pharma industry an important player on the global pharma stage. A critical inflection point is set to unfold in the generic markets in the next few years, especially the US/European markets. Indian pharma companies are eying the US generic drug market with pharma manufacturers filing as many as 143 drug master files (DMF) with the US Food and Drug Administration (USFDA), in the first half of 2005.

      The 143 Indian DMFs make up around 35% of the total 411 DMFs filed in the first half of this year (upto end of June). Products worth $40-50 billion will lose patent protection in the next five years.

      Indian companies have the strengths "world-class plants and formidable chemical synthesis skills" to compete in the generic markets. Generics have gradually inched up 22% of the prescription market in 1985 to 47% of a much larger market in 2002. Even though competition will be intense in global generic markets that hold a lot of promise, Indian companies have the capability to succeed in this space.

      On the domestic front, the pharmaceutical market has been growing at a CAGR of 8.7% over the last five years. Going forward, with the robust economic growth, large investment in infrastructure, improving regulatory framework, patent regime and dilution of price controls, one should not be surprised if all these factors result in a healthy double digit growth of the domestic pharma market. The absolute numbers of the entire domestic market will compare rather unfavourably even with that of individual companies internationally. However, the growth rate leading to an eventual large market size will make India a significant player.

      There have been various indicators for India's potential on the research and development front. For example, Mumbai-based Glenmark Pharmaceuticals Ltd's research product "Oglemilast", for asthma, has shown immense promise with studies moving to Phase II clinical trials with a development partner. However, India's strength on basic research has a long way to go. We would believe that strength on development and clinical research should be the driver for growth. India's potential for contract research lies in the fact that it possesses a large pool of talented, experienced and scientific manpower. There is also an excellent skill base in areas of chemical and biological sciences, which are a key expertise required for drug discovery and early development.

      High costs in US and Europe are putting pressure for procuring talent from Indian contract research organisation (CRO) firms.

      One of the other factors, which give India an edge over countries like China and Japan, is the wide usage of the English language, which the global investigators are comfortable with, thereby avoiding the need for translation. There is a high potential for developing India as a centre for international clinical trials and contract research.

      The most obvious benefit of conducting clinical trials in India is the potential for cost savings. It is estimated that a standard drug could be tested in India for about 60% of the sum it would cost to test in the US.

      Another indicator of India becoming an important player on the global pharma stage also comes form the flurry of corporate activity in the pharmaceutical sector. Bristol-Myers Squibb, Merck of US and Japanese majors are all set to enter India while Roche plans to make India its global hub for bulk drugs.

      At the same time, the Indian companies are also in the process of making their presence felt in the global pharmaceutical market.

      Towards this, Ranbaxy Laboratories, which acquired RPG Aventis of France, has already announced its intention of larger acquisitions in the US, Europe and India. Other companies such as Wockhardt, Torrent, Cadila, Jubilant, etc, have also made acquisitions in Europe.

      The Indian government is also doing its bit to support the industry, though there always exists room for improvement.

      To start with, foreign direct investment was permitted upto 100% under the automatic route followed by reduction in the number of drugs under price control over the years, and other fiscal benefits were granted to the Indian pharma industry.

      The introduction of Patents (Amendment) Act, 2005 is a step towards bringing India on international stage. All in all, there is a potential for India to become an important player on the global pharma stage.

      October 03, 2005


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