Increased US Vigilance on Imported Drugs Can Impact India.

MUMBAI : The US Food and Drug Administration sought to tighten vigilance on imported drugs in a plan that could potentially impact India's drug companies and its own regulator's vigilance standards. India is a large exporter of drugs to the United States.

In a report titled 'Pathway to Global Product Safety and Quality,' the FDA said it has outlined its strategy to deal with rising medicine imports. "There has been a perfect storm - more products, more manufacturers, more countries and more access," said FDA commissioner Margaret Hamburg. "A dramatic change in strategy must be implemented," she said.

The statement highlights four key elements of this strategy.

One, it intends to partner with regulators worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

Two, the coalitions will develop international data information systems and networks and share data and regulatory resources across markets.

Three, the FDA will build in additional information gathering and analysis capabilities using information technology and risk analytics.

And four, the FDA will increasingly leverage public and private third parties and industry to allocate resources based on risk.

The latest announcement is part of a continuous move to monitor imported medicine whether raw materials or finished drugs. "FDA regulated imports have quadrupled since 2000," Hamburg said.

"The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face."

The FDA increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and has opened a series of international offices in key locations including China and India.

Indian companies have already begun feeling the impact of stepped-up vigilance by the FDA in the last two to three years. The number of inspections is up, and so are the number of warning letters for quality gaffes. This latest move seems intended to tighten the screws further.

Given that India has the largest number of FDA-approved manufacturing facilities in the world outside the US, Indian regulators too may see a greater move by the FDA to engage them in safety and quality monitoring. Regulating the Indian drug industry is currently a responsibility shared by the Centre and states.

If the Indian drugs regulator co-operates more fully with FDA's stepped-up vigilance then companies may find that the bar for manufacturing for the Indian market also raised gradually. Many Indian companies follow a different, more benign set of rules when manufacturing for the local market as compared to western markets.

Source : economictimes.indiatimes.com