P.T. Jyothi Datta

Mumbai, Nov. 3 Not too many business or political conferences get by without talking about the emerging opportunities in China and India in the same breath, and in that order. But when it comes to tapping the generic medicine market in the US, India it seems may have the edge.

In contrast, the first Chinese generic company has received tentative regulatory approval from the US Food and Drug Administration, points out Dr Brian Tempest, Ranbaxy’s Chief Mentor and Executive Vice-Chairman.

In the case of drug master files (DMF) in the US, Indian companies filed half of the DMFs in the US. China seems to be seven years behind India, but this could change soon, observed Mr G.V. Prasad, Chief Executive Officer of Dr Reddy’s Laboratories.

Illustrating the point, Dr Tempest’s presentation quoting different sources showed that in the first quarter of 2007, India had 48 per cent of the DMF filings in the US, while China had only 17 per cent.

India’s DMF filings in the US increased from 187 in 2004 to 252 in 2005 to 357 in 2006. Comparatively, China’s DMF filings in the US increased from 48 in 2004 to 87 in 2005 to 128 in 2006.

DMF filings from India accounted for 27 per cent of US filings in 2004, 37 per cent in 2005 and 44 per cent in 2006, he said quoting varied sources. In the corresponding years, DMFs from China accounted for 9 per cent of US filings in 2004, up to 10 per cent and 14 per cent, respectively in 2005 and 2006, Dr Tempest told the Confederation of Indian Industry’s Pharma Summit.

India is increasingly finding it difficult to ignore China, a recent KPMG Pharma report observed. China is emerging as a strong competitor on the back of its cost competitiveness, strong government support (in the form of incentives), implementation of good manufacturing practice norms, aggressive exports thrust and increased consolidation to build Chinese pharma giants.

But, China lacks the required specialisation in some areas such as finished formulations, regulatory compliances for regulated markets and intellectual property rights development. In terms of the US FDA approved plants, China is behind India. And in 2007, India has filed 110 DMF filings, which is nearly three times that of China’s filings at 38, it said. Several Indian drug companies, including Ranbaxy, Sun Pharma and Aurobindo, have operations in or import ingredients from China.

Finished medicines

Mr D.G. Shah of the Indian Pharmaceutical Alliance observed that China has a five-year lag behind India when it comes to making finished medicine forms and seeking permissions in selling them in regulated markets like the US.

Credibility may also be a dampener, he added, given the recent recalls and other regulatory issues in China. Despite the competitive pricing in bulk-drugs, India has an edge when it comes to meeting US regulatory standards, he added.