'Indian pharma companies face problems in US due to documentation'

Problems faced by Indian drug makers in the US are not related with quality but more due to documentation and data maintenance, a senior government official today said.

While stressing that India is already engaged with the USFDA to sort out the matter, the official, however, said domestic firms would have to meet the requirements of all the countries where their drugs are exported.

"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, told reporters here.

The USFDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, their largest export market.

The US health regulator on January 23 banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was the company's fourth plant to face regulatory action from the USFDA, after Mohali, Paonta Sahib and Dewas plants.

In 2013, Ranbaxy had agreed to pay a fine of $500 million to US authorities after pleading guilty to 'felony charges' relating to manufacture and distribution of certain adulterated drugs made at the Paonta Sahib and Dewas units.

Another Indian firm, Wockhardt, had its two plants put under import alert by the USFDA.

Pandey said that Indian government is working closely with the USFDA to deal with the issues.

He said that workshops are going on across the country on pharma sector where officials from domestic industry and US are participating to understand each other's issue.

"In the coming days, workshops are there in Goa and Ahmedabad," he said adding "They (domestic firms) have to meet the requirements of the markets. There has to be no compromise on regulatory standards and quality".

Pharmaceuticals Export Promotion Council (pharmexcil) Chairman Ashutosh Gupta too said that the Indian industry is complying with all the international standards and norms.

"We have a highly dynamic regulatory framework and we are closely working with the USFDA on all the matters," Gupta said.

On the recent report of USTR, Pandey reiterated that Indian intellectual property rights are in compliance with the WTO norms.

"India has made amply clear at the international forums that India is fully TRIPS compliant and that is accepted," he said.