Indian Drug makers face problems in US due to Documentation

The problems faced by Indian drug makers are in the US are not related with quality but more because of improper documentation and data integrity. Although India is still engaged with the US FDA to solve the matter, a senior government official said that the companies would have to meet the specified requirements of all the countries where the drugs are being exported.

The US FDA has taken a series of action against Indian Pharmaceutical companies, confining their shipments to US, their largest export market. The US health regulators have banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was company’s fourth plant to face regulatory issues from USFDA. Wockhardt is another Indian firm that has been banned for import from its two plants to US market. Indian government is working closely with the US FDA to deal with the issues.

Pharmaceuticals Export Promotion Council (pharmexcil) Chairman too said that the Indian industry is complying with all the international standards and norms. And we have a highly dynamic regulatory framework and we are closely working with the USFDA on all 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. They (domestic firms) have to meet the requirements of the markets. There has to be no compromise on regulatory standards and quality.