Generics India’s Generics Overview: A Market on the Verge of Something Big

Editor: Dominik Stephan

The India Brand Equity Foundation (IBEF) has compiled its findings and released an overview of the current generics market in India. They predict that the Indian pharmaceutical 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.

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(Picture: PROCESS)

Delhi/India – Over the last three years exports of pharmaceuticals (largely generics) have grown at over 21.5 per cent (CAGR) and now accounts for over $ 13 billion in annual sales. Highlighting India’s dominance, nearly 40 per cent 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.

This huge growth in generics production has seen the country become a hotbed of manufacturing innovation – India has over 3000 DMFs registered with USFDA – 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).

Indian Brand Equity Foundation

With the world’s pharmaceutical development manufacturing base moving to India—there are 546 USFDA 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.

Recognizing this opportunity, the Government of India is putting in place supportive initiatives with the goal of cementing the country’s position as the ‘pharmacy of the world’ and creating a global innovation hub. With generics predicted to rise to 35 per cent of global pharmaceutical market value by 2016 (some $400bn+), and with an annual growth rate of 27 per cent amongst Indian generics exports (comparing very favorably with the global average of 10 per cent) the Government and Pharmexcil are forecasting much of this revenue will be reinvested across the country in new research- leading to a steady pipeline of future drug targets.

Schemes for Generics in India

In support of this, the Indian Government has committed to three schemes including a major multi-billion dollar initiative with 50 per cent public funding through a public-private partnership (PPP) model to harness India’s innovation capability. In addition, the Government has made tax-breaks available to the pharmaceutical sector and a weighted tax deduction of 150 per cent for any R&D expenditure incurred. Additionally, they have also introduced 19 dedicated Special Economic Zones to help stimulate pharma sector investment across the country.

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