Pharmaceutical Industry India to Become Global Pharmacy: Strong Generics Market boost R&D

Editor: Dominik Stephan

More than just cheap generic drugs: With exports growing at nearly 30% per year, India's pharmaceutical industry is well positioned for greater research spends. The country has already submitted 112 ANDAs in 2013, nearly 40 percent of last year global ANDA-volume with the FDA.

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(Picture: PROCESS)

A recent research by the India Brand Equity Foundation (IBEF) predicts that the Indian pharma market is now at the precipice of the next stage in its development, having seen manufacturing innovation and development technologies rise- thanks to the explosion in generics production.

Over the last three years exports of pharmaceuticals (largely generics) have grown at over 21.5% and now accounts for over US $ 13 billion in annual sales. Highlighting India’s dominance, nearly 40% of Abbreviated New Drug Applications (ANDA) received by the FDA in 2012 were from India, with a further 87 confirmed and another 25 already received between January and June 2013.

India to Challenge Big Pharma

This huge growth in generics production has seen the country become a hotbed of manufacturing innovation – India has over 3000 DMFs (drug master files) registered with the US FDA – which coupled with increased investments in R&D means India is now ready to challenge traditional big pharma and start producing more patented products.

A natural evolution of the success of the generics market has been the rise in supergenerics across India where much R&D spend is currently being invested (e.g. Lincoln Pharma’s patent for NDDS).

With the world’s pharmaceutical development manufacturing base moving to India – there are 546 FDA approved company sites (second only to the US), 23 companies holding 1100 authorisations with UK's MHRA, and 166 companies with CEPs (Certificates of Suitability) from EDQM – coupled with the rise in supergenerics, the country’s next natural step is to use its world leading development expertise in the creation of new chemical entities.

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