New Delhi, May 6: Problems faced by Indian drug makers in the US are not related to quality but to documentation and data maintenance, a senior government official said today.
Stressing that India is already engaged with the US Food and Drug Administration (USFDA) to sort out the matter, the official said domestic firms would have to meet the requirements of all the countries where their drugs were exported.
The USFDA had in the past one year found manufacturing violations by several plants of generic drug suppliers such as Ranbaxy, Wockhardt, Sun Pharmaceuticals, RPG Life Sciences and Agila Specialities. A series of actions have been taken against these companies to restrict their shipments to the US. Some factories have also been barred from supplying to other markets such as the EU.
“In none of those (cases taken up by the USFDA), quality was an issue. It was the documentation and data maintenance process. Quality was not an issue as far as supply of generics are concerned,” joint secretary in the commerce ministry, Sudhanshu Pandey, said.
USFDA officials are in the country to hold talks with regulators and industry players to iron out their differences. The USFDA is expected to explain its expectations from domestic manufacturers and get their feedback.
Workshops will be held in Hyderabad, Goa, Ahmedabad and Chandigarh where officials from both the sides will participate to understand each other’s viewpoints.
As much as 55 per cent of the $14.5-billion pharma exports are meant for the highly regulated markets, including the US and the EU.
Pharmaceutical exports registered the slowest growth in 15 years at 1.2 per cent to $14.84 billion last financial year.
Exports stood at $14.66 billion in 2012-13.
According to industry observers, exports will miss the target of $25 billion for 2014-15.
“The dialogue process would resolve the differences between the two trading business partners. The issue of concerns can be addressed through regular interaction,” Ashutosh Gupta, chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), said.
He said key buyers and importers from major economies, regulators and government procurement agencies from 25 countries, including the US and EU, would attend the iPHEX 2014, an industry event, later this month.