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The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market
Date:1/30/2013

NEW YORK, Jan. 30, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market

http://www.reportlinker.com/p01089686/The-Indian-Pharmaceutical-Industry-2013-Coming-of-Age-in-a-Global-Market.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Generic_Drug

The 20 companies examined in this report had combined sales of more than US$17.4 billion in their most recently reported fiscal year, which generally concluded on 31st March 2012. Ranbaxy reported revenue of Rs.99,769 million (US$2,145 million) for the calendar year ended 31st December 2011, making it the leading company in terms of revenue. Of the companies listed, 18 reported improved sales over 2010/11.

New Guidance on Biosimilar Manufacture

In 2012, new "Guidelines on Similar Biologics" were published. The Guidelines were prepared by the Central Drugs Standard Control Organisation and the Department of Biotechnology, and lay down the regulatory pathway for a biologic claiming to be similar to an already authorised reference biologic. The Guidelines apply to both locally-developed and imported products, although the precise approval process differs in each case. The document notes that a reduction in testing and data requirements at the preclinical and clinical level is likely to be possible for a biosimilar, however, 'it is essential that the testing of the similar biologic be sufficient to ensure that the product meets acceptable levels of safety, efficacy and quality to ensure public health'.

A number of Indian companies are active in the biologics segment of the pharmaceutical market. Leading indigenous biot
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