The Department of Pharmaceuticals (DoP) will form a working group with representatives from the Department of Biotechnology (DBT), industry bodies like FICCI and the leading industry players to work out strategies to make India a leader in the biopharma sector, through various initiatives including streamlining the regulatory system.

This was decided after a day-long interaction between the government and the industry on biopharma recently. Both the industry and the government decided to focus on biopharma which is growing fast in other regions of the world. The overall goal, set by the DoP and the industry, is to make India a leading producer of affordable biopharmaceutical products by 2020.

The DoP also assured the industry to look into the demand for the simplification of the regulatory system by setting up a single window clearance instead of having multiple bodies. DoP secretary Ashok Kumar said he would consult with the DBT, DCGI, ICMR and other concerned agencies about the possibility of simplifying the regulatory mechanism.

"We have been the leaders in the generics but the time is changing in the sector. Given the question of taking the chemistry route or biology route, we should better now focus on the latter, in the changing circumstances," he said.

The biopharmaceutical market is worth 137 billion dollars world over and is growing fast. At present, India has a miniscule share of 1.4 per cent from this huge bounty. Industry experts estimate that it could grow up to 319 billion dollars by 2020. Moreover, at least 48 products with combined sales of nearly 73 billion dollars in 2009 are due to come off patent over the next decade.

India is aiming to capture 10 per cent of the global market for biosimilar by 2020 and become one of the top five producers in the world. For this, an investment of about one billion dollars needed for the next five years. If the proposed plans are implemented properly, India can bring in additional revenues of 4.3 billion an year, according to the industry experts.