Visiting India: Sharing a Vision for Strengthening Food and Medical Product Safety

By: Margaret A. Hamburg, M.D.

Fresh mangos, bananas and other native fruits add a pop of color and provide the backdrop while we ride along the busy streets of Delhi. While en route to the first of several meetings I held with Indian regulators, I can’t help but marvel at the vibrant buzz of India’s capital and the progress that has been made since I traveled here years ago as a young woman. Since that time, the rapid globalization of commerce has posed significant challenges to ensuring consumer safety as the number of products and suppliers entering the U.S. has increased. India now represents the 3rd largest trade partner, 2nd largest supplier of over-the-counter and prescription drugs, and 8th largest supplier of food to the United States.

Margaret Hamburg and officials in India

(L-to-R) Arun Panda, Joint Secretary, Ministry of Health and Family Welfare; Shri Keshav Desiraju, Secretary, Ministry of Health and Family Welfare; Shri Ghulam Nabi Azad, Minister, Ministry of Health and Family Welfare; Dr. Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration; Dr. Altaf Lal, Director of U.S. FDA’s India Office; Nancy Powell, U.S. Ambassador to India.

On Monday, I began my first official visit to the country as Commissioner of the FDA. I met with officials from the Indian government who oversee the country’s health-related matters as well as those responsible for overseeing the export of foods to the U.S. and more than 200 countries around the world. These meetings provided the opportunity for me to discuss our shared vision for strengthening the quality of the foods and medical products exported from India to the United States. Ultimately this vision is intended to enhance consumer confidence in these products both at home and abroad.

As two of the largest democracies in the world, our countries have enjoyed an enduring partnership and commitment to collaborate on initiatives designed to enhance both our economies and the lives of the people in our respective countries.

Ensuring that the products distributed in the United States meet our requirements for product safety and quality is among my top priorities as Commissioner. Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.

While the FDA will take appropriate action against any company that doesn’t meet our requirements, we are also willing to work with them to address their issues. All consumers deserve access to safe and affordable drugs and should not have to sacrifice quality to get that.

Officials at India’s Ministry of Health and Family Welfare share this goal. In the spirit of continued collaboration and a commitment to quality, our agencies signed the first-ever Statement of Intent. Our organizations plan to collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.

While the Statement of Intent is an important milestone, I am proud to report that FDA’s Office in India has already been working closely with India’s drug regulators to reinforce the importance of producing quality products for patients. Drug and food regulators in India have participated in FDA-hosted workshops and observed FDA inspections of manufacturing facilities and clinical sites with operations in India.

During my visit I am eager to learn more about the industries that produce products for the United States and to meet with business leaders where I will reinforce our expectations that they meet our requirements for ensuring that consumers here and around the world have access to safe and high-quality products.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

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