Indian Drug Makers Face Problems In U.S. Due To Documentation And Data Maintenance: Report

In 2013, Ranbaxy had agreed to pay a fine of U.S. $ 500 million to U.S. 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 U.S.FDA. 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 U.S. 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 fullyTRIPS compliant and that is accepted," he said.