About a shared vision on safety issues

Fresh mangoes, bananas and other native fruits add a pop of colour 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 travelled here years ago as a young woman.

The partnership Since that time, the rapid globalisation of commerce has posed significant challenges to ensuring consumer safety as the number of products and suppliers entering the US has increased.

India now represents the third largest trade partner, second largest supplier of over-the-counter and prescription drugs, and eighth largest supplier of food to the US.

On Monday, I began my first official visit to the country as commissioner of the US Food and Drug Administration.

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 US and more than 200 countries around the world.

These meetings provided the opportunity to discuss our shared vision for strengthening the quality of the foods and medical products exported from India to the US.

Ultimately, this vision is intended to enhance consumer confidence in these products both at home and abroad.

Top priority 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 US meet our requirements for product safety and quality is among my top priorities.

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.

Working together 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 organisations 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.

Secure access 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 US 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.

(This article was first published as a blog post on FDA Voice)

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