In the context of global slowdown and its impact on all sectors is normally expected to be downtrend. However, Indian economy being semi-closed the prophets of Indian economy were constantly impressing on Indian public not to bother about global slowdown as the Indian economy is based on strong fundamental market. To verify the substance of the foundations of Indian economy we have taken a study of Indian pharmaceutical industry and analysed its strength and weaknesses based on their activity grid covering the entire spectrum of the indications for last six months. The Indian pharmaceutical industry had grown over last 50 years and has participation of multinationals and indigenous manufacturers, and biotechnology based industries. Indian pharma industry is a significant global player in terms of quality and quantity. There are spectrum of small, medium and major industries, which manufacture most of the important drugs which are used not only by India but also by other developed and developing countries. Many of these MNCs, foreign investors and venture capitalists are collaborating with Indian companies, which often offer as much as 30 to 50 per cent growth; savings in total drug discovery and development costs. Recent amendments to India's patent laws have also made India more attractive as a drug discovery destination. In 2005, India amended its patent laws to comply with the World Trade Organization's (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international treaty mandating minimum standards for trade and intellectual property protection. These amendments allowed, for the first time, patent protection in India for pharmaceutical products. The earlier law provided patent protection only for the process of making the drug, not for the drug itself. The pharma industries started looking outwards in late 2005's due to amendment of Indian Patent Act which had a transformation from process patent to product patent. Recently, a growing number of MNCs have entered into more collaborative ventures with Indian pharmaceutical companies and contract research organizations, extending well beyond task-driven outsourcing. These transactions involve more complex intellectual property considerations. A recent Price Waterhouse Coopers report indicates that India could well become one of the top 10 global pharmaceutical markets by the year 2020. Thus, any pharmaceutical company doing research and development in India will likely choose to patent its technology in India.
Current scenario
India currently represents just US$6 billion of the $550 billion global pharmaceutical industry but its share is increasing at 10 per cent a year, compared to 7 per cent annual growth for the world market overall. Also, while the Indian sector represents just 8 per cent of the global industry total by volume, putting it in fourth place worldwide, it accounts for 13 per cent by value, and its drug exports have been growing 30 per cent annually. The pharmaceutical industry in India has made phenomenal progress in the past 10 years. With over $ 8 billion in domestic sales and another $ 5 billion in exports in the year 2006, both growing at double digit, it has acquired its place in the sun. It has also started making global footprints and over $ 2.5 billion worth of acquisitions were made overseas in past couple of years. Undoubtedly, the major inflexion point in the history of Indian pharma industry is the passage of product patent law in 2005. Indian pharmaceutical industry strived hard and learned the rules of international market. Many of the industrial units raised their standards to match the global regulatory authorities like US FDA, etc. There are largelnumber of US FDA facilities which is largest approved facilities anywhere in the world apart from USA itself. The CRO also grew exponentially at an annual growth rate of 15-20 per cent.
There are many generic drugs manufactured in India for exporting into countries like USA, Canada, Australia etc.
The Indian pharmaceutical industry is a net exporter of bulk drugs and generics and ranks 17th in the world in terms of bulk drug and formulation exports. In 2004-05 the net pharmaceutical export was more than US $ 3.75 billion, formulations accounted for 55 per cent; while the remaining 45 per cent; came from bulk drugs. US, Germany, Russia, the UK and China are the top five export destination for the Indian pharmaceutical sector. As per the Government of India's annual report 06-07 the Indian pharma industry is worth about $12 billion (over Rs 55,000 crore) as of now which includes $4.5 billion in exports of drugs, pharmaceutical and fine chemicals. The pharmaceutical industry needs to focus more on R&D and better productivity to capitalise on the immense existing opportunities. India, with its inherent competitive advantages and cost-effective manufacturing capabilities, has now become one of the most preferred destinations for Contract Research and Manufacturing Services (CRAMS).
Conclusion
The Indian market has some unique advantages. India has a 60-year-old thriving democracy. It has an educated workforce and English is business language. It has a solid legal framework and strong financial markets. More than 9,000 companies are publicly listed. Professional services are easily available. There is already an established international industry and business community. It has a good network of world-class educational institutions and established strengths in information technology. The country is now committed to a partial open economy and globalisation. Above all, it has about 200 million middle class market, which is continuously growing. Over time the international pharmaceutical industry has been finding great opportunities in India.
The Indian pharmaceutical industry players in the future can continue to look forward with confidence. There are immense opportunities for pharmaceutical players both at the domestic as well as the global level, but along with opportunities are challenges which need to be overcome in order to achieve sustainable growth in the future. The future will be extremely promising with many more milestones to come in the journey of the Indian pharmaceutical industry.
(The authors are with Manipal College of Pharmaceutical Sciences, Manipal-576104)