INDIAN PHARMA; CHANGING DYNAMIC_An essay by S. Vijayakirubha

Introduction:

The Indian Pharmaceutical Industry, sized at USD 34 billion (including exports) in 2013-14, has remained on astrong growth trajectory, over the past few years. The industry size is expected to increase to USD 48 billion byrd th 2017-18 at a CAGR of 14%. Indian Pharma industry is ranked 3 globally in terms of volume and 10 in terms ofvalue, supplying 10 % of global production.

Evolution of the Indian Pharmaceutical:

The Indian pharmaceutical industry has grown rapidly over the last few decades. Prior to 2005, the Indianregulatory system recognized only process patents. This helped build a firm foundation for the strong andcompetitive domestic pharmaceutical industry. During this phase, the prevalent price control mechanisms.

Helped companies deliver medicines at affordable prices, to patients across India. The different phases that theIndian pharmaceutical industry has gone through, during the pre-patent (till 2005) and post-patent (post 2005).

Regulatory Environment in India:

The Pharmaceutical Industry is characterized by maintenance of high quality standards as it concerns the livesof people. Regulatory bodies impose regulations to ensure that drugs meet the safety and quality standards. Regulatory bodies not only ensure that pharmaceutical companies meet the set quality standards.

 But also, ensure that the pharmaceutical companies do not charge unreasonable prices from consumers. The stringency of regulatory procedures varies across countries.

On the basis of established regulations andpatent laws, the global pharmaceutical industry can be broadly classified into regulated and semi-regulatedmarkets. Regulated markets include the USA, EU and Japan that have established systems of patent laws andsophisticated regulatory systems for controlling drug quality.

 On the other hand, semi-regulated marketsinclude countries such as China, India and South Africa, which have less stringent systems of patent laws andless sophisticated regulatory systems for drug quality control.

The India Advantages in the Life sciences Industry:

The India has emerged as a pharmaceutical supplier in the international markets. This is not only because of a low-costmanufacturing, operations and research base but also a combination of additional factors such as processimprovements in manufacturing API, faster recruitment for conducting clinical trials, availability of skilled manpower and developed regulatory skills.

Indian Pharmaceutical players sharpen focus on regulated markets

Large players enjoy better profitability and undertake higher capital

Investments

Over the past few years, Indian pharmaceutical players have been increasingly tapping opportunities in globalgenerics markets, especially the US and Europe. Meanwhile, mid-sized and small-sized players have targetedsemi-regulated markets of Africa, Asia and Latin America to enhance their distribution network before exporting to regulated markets.

Conclusion:

India is one of the fastest growing economies of the world, and the IndianPharmaceutical Industry has been animportant constituent to the pharmsector worldwide due to the recent changes in patent laws, the rising use ofgenerics, high cost competitiveness, and availability of large scientific research force in the country.It has been estimatedthat the cost to conduct a trial in India is 50% lower than that of a developed market. Thus, India is definitelypoised to become one of the leading Pharmaceutical markets in the world.