A rash of recent inspections that led to FDA enforcement actions against a number of Indian biopharma companies doesn’t mean the U.S. agency is targeting drugmakers in that country.

Rather, it’s an indication of how important India has become as a U.S. source of APIs and finished drugs, FDA Commissioner Margaret Hamburg said in an international media briefing following her historic visit to India. The country, known for its generic drugs industry, is now the third largest trading partner for the U.S. when it comes to FDA-regulated products and the second largest supplier of prescription and over-the-counter drugs, in terms of volume, she added.

Overall, India ranked as the 11th top trading partner for the U.S. in 2013, according to the U.S. Census Bureau. Canada, China and Mexico topped the list, followed by Japan, Germany, South Korea, the UK, France, Brazil and Saudi Arabia. While India may ship the highest volume of drugs to the U.S., most of the products are generics. In terms of valuation, India is further down the list of U.S. drug suppliers. (See BioWorld Asia, Feb. 5, 2014.)

Given the volume of products they’re sending to the U.S., Indian drugmakers should expect FDA inspections, which are a routine part of the process of approving drug applications and ensuring that the drugs entering the U.S. market are safe and meet FDA quality standards, Hamburg said.

As the first FDA chief to officially travel to India, Hamburg saw her visit as an opportunity to build relationships with Indian regulators and industry. She met with drugmakers in India to stress the importance of quality in terms of public trust in their brands.

To help build that quality, Hamburg signed a nonbinding, five-year statement of intent with the Indian Ministry of Health and Family Welfare. The statement reflects a commitment to work together to improve their lines of communication and to ensure that the products being exported from India meet FDA standards. To help uphold its end of the commitment, the FDA plans to add seven new positions to its 12-member staff in India.

The commitment also includes offering training and workshops so Indian drugmakers will understand the quality standards the FDA expects.

Hamburg tied quality standards to drug shortages and the integrity of a supply chain that is becoming much more complex. She said the FDA wants to work with all drugmakers, regardless of where they’re located, to ensure the quality and availability of important drugs.

But the work doesn’t stop with India’s agreements with the U.S. If India is to continue as a significant player in the global marketplace, the country’s health officials must be at the table when regulators from various countries sit down to discuss harmonization and globalization efforts, Hamburg said. They must understand what is required in other countries and have a say in the development of world standards.

While the trip was Hamburg’s first official visit to India, it was not her first trip as FDA chief. She has met with officials in China twice, visited with regulators in other countries and plans to engage with officials elsewhere in the future.