Ranbaxy effect: Indian government defends pharma industry

Few isolated cases cannot undermine well regulated system, says commerce ministry

Published on:

03 Jun 2013, 3:36 pm

The Indian government appears to be keen to protect the reputation of the Indian pharma industry, which has been dented by the recent incident of Ranbaxy pleading guilty to selling sub-standard drugs in the US. In a press release issued on Monday, the department of commerce under the Union Ministry of Commerce and Industry said the Indian pharma industry is well regulated and that it could not be undermined because of a few isolated cases.

Indian pharma's success story

India had, as on December 30, 2012, over 3,000 drug master filings (DMF’s) with USA amounting to almost 40 per cent of the total DMF’s filed with USFDA. These are filed by over 233 different companies from India
During 2012, USFDA has granted 476 ANDAS (abbreviated new drug application, generics) and India has 178 market authorisations of them—amounting to 37.4 per cent of the total
As on Dec 30, 2012, over 2,275 ANDAs are approved by USFDA, covering over 31 different companies
There are over 550 manufacturing sites registered with USFDA, out of which 323 sites are approved by USFDA as on March 31, 2013
130 companies have over 902 CEP’s (Certificate of Suitability to the monographs of the European Pharmacopoeia) approved by EDQM (European Directorate for the Quality of Medicines and Healthcare), which is more than 25 per cent of the total CEP’s approved by EDQM globally
India has a share of 15 per cent of US generics by way of volume

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