LIFE-SCIENCES INDUSTRY: India tipped to be bio-IT leader, says IDC

The growth of bio-IT spending within India’s life sciences industry is set to increase at a compounded annual growth rate of 65 per cent to touch $120 million by 2006, according to an IDC report.

The report says the life sciences markets of India and Japan hold great promise.

IDC expects India to develop into a significant global player over the next decade and beyond, aided by the continuing disintegration of the blockbuster, multi-billion-dollar drugs model the world over.

In a recent analysis, IDC has pointed out that India’s fledgling biotech sector, which is expected to grow 90 per cent year-on-year during the forecast period, the most dominant force behind the rapid adoption of bio-IT.  IDC believes India will become an ideal center for outsourcing R&D and drug development processes.

“With many global branded drugs going off-patent in the next few years, India has the capital infrastructure and the scientific capabilities to produce vastly cheaper generic drugs that can severely undermine branded names,” said director, Bio-IT and Life Sciences Research, IDC Asia/Pacific, Philip Fersht.

With intense demand for low-cost R&D, India’s developing skills and infrastructure in the R&D, India’s developing skills and infrastructure in the R&D phases of drug development are providing an enticing proposition for global pharmaceutical companies and investors, the report points out.

It adds that India’s skills in technical computing, bio-informatics and chem-informatics, data integration and the ability to resolve issues surrounding unstructured data are key to the lead compound phases of the drug discovery cycle.

IDC has forecast that pharmaceutical companies will look to out-source costly areas of R&D to places like India.  “Once India develops a genuine global reputation in life sciences innovation, it will attract investor attention to develop its own intellectual property,” Fersht said.

IDC’s research and analysis is focused on the fact that the development of bio-sciences in India will result in heavy investment in IT infrastructure to enable biotechnology processes.

This growth will be further fuelled by the increasing R&D collaborations between Indian organisations and foreign firms, the report says.

[Ref: The Times of India, Jan. 20, 2003]

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INDIAN pharmaceutical companies have further consolidated their position as the leading DMF (Type 2) filers in the United States. From 37 DMF (Drug Master Files) fillings in the calendar 2000, second only to 44 by Italian companies, the number of filings by Indian companies has jumped to 77 in 2002 more than the fillings of China, Spain and Italy put together.

DMF’s are submissions to the US Food and Drug Administration (USFDA).  These provide information about facilities, process, or ingredients used in the manufacturing, processing, packaging, and storing of a medicine.  A DMF of Type II, the most important among the five types, relates to drug substance, drug substance material, and material used in their preparation or a drug product.

Significantly, submission of a DMF is not mandatory by either law or FDA guidelines for drugs proposed to be sold in the US.  However, most holders do submit their DMFs as it does serve a useful purpose.  The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or an export application.

Therefore, an increased number of DMF filing by Indian companies is an indication of their willingness and the ability to sell their drugs in the US market.  It is also an affirmation of the advanced skills of Indian pharmaceutical companies in process chemistry.  The results are already beginning to show in the export figures of the leading pharma companies.

According to the data with the USFDA, Dr Reddy’s Ranbaxy, Wockhardt and Cipla were the leading DMF filters in the US in the calendar 2002.  In keeping with this trend, the total exports from these companies, of which a major component is to the US, have shown an impressive improvement over the last couple of years.  Moreover, an increased number of DMF’s are now for formulations against bulk drug filings of earlier years.  This is a welcome trend as the margin in formulations is higher than in bulk drugs.

[Ref: The Economic Times, Feb. 04, 2003]

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Patents are the life blood of the pharmaceutical industry.  And with drugs worth a combined $44 billion in annual sales facing patent expiry by the end of 2003.  Indian firms are scrambling to exploit the opportunities this presents.

Among developing countries, Indian firms are already way ahead in the race.

During the period, India registered the highest growth rate of 51.9 per cent among the major patent applicants in the developing world.  With 480 applications, India lags only South Korea (2,552) and China (1,124) among developing countries under the Patent Co-operation Treaty.

The drugs industry, which rakes in over $300 billion a year, argues that the exclusivity guaranteed by patents is an essential reward for innovation.  That may be the case, but the fact is that by the end of 2003 the US generics market will account for more than 40 per cent of the global generics market.

More importantly, 60 per cent of the generics sold in the US are imported, and obviously the most cost-effective supplier has the best chance of breaking into an increasingly competitive market.

[Ref: The Times of India, March. 07, 2003]

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