India pharma produces high-quality drugs

The Ministry of Commerce and Industry is confident about the quality of Indian drugs.


New Delhi, June 4, 2013: The Government of India believes that the drugs proced by the Indian pharma industry are of global quality standards and the Indian pharma sector itself is a highly regulated sector.


Being the fourth largest in the world in terms of production volumes, over 55 per cent of its total exports go to highly regulated markets like the USA and Europe. India has 550 registered manufacturing sites and 323 approved manufacturing sites by US Food and Drug Administration (FDA). India held over 2275 ANDA’s (Abbreviated new drug application) approvals from USFDA covering over 31 different companies as on December 30, 2012. In fact, India has over 350 manufacturing sites endorsed by the European Union (EU) for their good manufacturing practice in India as on April 30, 2013.


The Ministry of Commerce and Industry also said in a statement that the reports of the US Health Regulator (USFDA) penalising Indian companies is only a small aberration.


The Indian government has been continuously taking steps to ensure the manufacture and export of quality drugs including efforts like the trace and track mechanism introduced by the government.


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