NEW DELHI: Against the backdrop of the US and EU moves to fine drug firm Ranbaxy, the government has said drugs produced by Indian pharma industry are of proven global quality standards and the sector is a highly regulated one.
“The pharmaceutical sector is a highly regulated one and the exports are heavily guided by various regulatory regimes of the importing countries…,” the Commerce and Industry Ministry said in a statement.
Citing statistics, the government said “The strong presence of Indian industry in the US and the reports of US FDA penalizing Indian companies are only a small aberration.”
The statement also assumed significance on a day there were reports from Brussels that European Union’s anti-trust regulators may fine the domestic pharma company for allegedly blocking of entry of cheaper generic medicines in the market.
Reports said that Ranbaxy was among the nine companies that are to be fined for the allegedly blocking the entry of the generic medicines in the EU.
However, Ranbaxy Laboratories declined to comment on the reports.
The government statement said India has proven global quality standard capabilities as measured by number of Abbreviated New Drug Application (ANDA) approvals, DMF filings, USFDA/UK MHRA approved manufacturing facilities/bio equivalence centers, which are considered as key indicators for assessing the capabilities of any national pharma sector.
“This fact is further firmly demonstrated by the trends in the number of product approvals received from various major regulatory authorities of the world,” it said.
All the concerned organizations in the government are constantly interacting to ensure that India’s image as a safe exporter is protected from all angles. -PTI
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