Friday, September 29, 2006

Indian Pharmaceutical industry

Battle over generic drugs
Indian companies always look for an opportunity to play the generics market. They wait for the patents of the US companies to expire and come up with low cost generics.

When Indian companies do so, US companies usually file law suits against the Indian companies (patent challengers) within the 45 day period prescribed by the Hatch-Waxman Act. Nowadays, instead of filing the cases immediately, the US companies are resorting to allowing the Indian companies enter the market. Then after a few months of sales, they file a law suit seeking triple damages.

The innovator companies are also using the authorized generics more aggressively than before. They are launched at very competitive prices and sometimes, even before the patent expires.

The global generics industry is expected to grow at 10-12% over the next few years against the 6-9% for the innovative drugs market.

The domestic pharma is growing by 17% to Rs. 25,700 cr in the 12 month period ended July 2006.

Global contract research and manufacturing services market
This market currently stands at $100 bn and is expected to touch $168 bn by 2009.
The contract research market is expected to reach $21 bn by 2009 from $14.5 bn in 2004.
Outsourcing in the drug discovery alone stood at approx. $4 bn in 2005 and is expected to reach around $7 bn registering a growth rate of 15-20%.

Process of Clinical trials
Research studies in human volunteers are conducted in three phases. At each phase, they have a different purpose and help scientists to answer different questions. In the first phase, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects. In the second phase, the experimental drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In the third phase the drug or treatment is given to large groups of people (1000-3000) to confirm its effectiveness, monitor side effects and compare it to other existing treatments. It is the last phase before the launch of the new molecule.