US FDA to increase scrutiny of food and drug firms in India

The US Food and Drug Administration (FDA) is planning to increase the frequency of inspections in India and will collaborate with the country's regulatory authorities at the centre and state level. 

"We will increasingly build relationships with the Indian industry and regulators through joint inspections, inspector training, data sharing etc and it will evolve in the coming years," said Howard Sklamberg, the US FDA Deputy Commissioner for Global Regulatory Operations and Policy.  

Exports of food and drugs to the US from India have increased over the years and that warrants more inspections and scrutiny by the FDA. The US regulator has taken enforcement action against companies not meeting their standards in recent years, said Sklamberg.

Data management is an important issue for many drug companies worldwide which often attracts scrutiny from the regulators. The FDA does not discriminate against any particular company or a nation,  said the official while reacting to allegations that Indian drug companies are increasingly found guilty of poor data maintenance and in many cases falsified data.  

The regulator also said language is not a barrier in its inspections. "We require data and numbers for evaluation and those are same everywhere", said Sklamberg, after a two week-long tour of India, visiting facilities and meeting officials.

The US FDA is developing many matrix and policies for future, including a system for incentivizing firms that try to establish and maintain higher level of quality standards, said the official. The FDA will soon fill up its 19 sanctioned posts in India, he added.